Inadequate pain management with opioids fentanyl and morphine by paramedics and emergency physicians in rural Germany: an observational study

Abstract

Background

Between 20% and 30% of patients in Europe receive inadequate prehospital analgesic therapy by emergency medical services. Current study investigated the group of patients with an NRS > 4 (Numeric Rating Scale) with regard to opioid dosages, leading diagnoses and changes in opioid applications following the removal of the requirement for an emergency physician callout.

Methods

The application protocols of 1147 patients (over 106 months) were evaluated. Missions were categorised according to opioids, symptom groups, diagnosis groups or accident mechanisms. Pain intensity, vital signs were evaluated before and after analgesia, as well as any adverse effects.

Results

The target NRS of ≤ 4 was not achieved in 26.5% of the cases. The average pain level of these patients upon admission to hospital was NRS 5.8 ± 1.2. No significant difference in the dose of fentanyl administered exclusively by paramedics was found between the groups (NRS ≤ 4: 0.155 ± 0.078 mg versus NRS > 4: 0.156 ± 0.082 mg). The majority of the patients with insufficient pain management were assigned to the symptom groups “trauma pain” (42.8%, NRS: 5.8 ± Ta1.2), “visceral pain” (22.0%, NRS: 6.1 ± 1.4) and “back pain” (17.8%, NRS: 5.8 ± 1.1), the injury pattern “fall” (27.6%, NRS: 5.7 ± 1.2), the diagnosis fields “acute abdomen” (26.0%; NRS: 6.1 ± 1.4) and “lumbago” (17.7%, NRS: 5.8 ± 1.1) were leading. The diagnosis group ‘visceral pain’ (p = 0.00024) was significantly more frequently associated with failure to achieve the target NRS. There was no increase in side effects in inadequately treated patients compared to patients with NRS ≤ 4. The proportion of inadequately treated patients increased significantly after the abolition of the requirement to call an emergency doctor to the scene (p = 0.045).

Conclusions

Approximately one quarter of patients had excessive pain levels upon handover. We suggest insufficient titration and/or limited dose escalation of opioids by paramedics and emergency physicians to be the important contributor to inadequate treatment.

Trial registration

Not applicable.

Background

An important task of the emergency medical services is the treatment of severe pain at the scene of an incident. Patients in severe pain assess the quality of prehospital care primarily based on the success of pain management [1]. Emergency medical services in Germany have a selection of highly effective analgesics at their disposal, the most commonly available substances of this type being esketamine (98.7%), morphine (98.7%) and fentanyl (85.7%) [2]. Recent studies from Germany and Europe report that 20 to 30% of patients receive inadequate analgesic treatment (NRS > 4 upon admission to hospital) [3–7].

Most emergency calls in Germany are handled by non-medical emergency service personnel. An emergency doctor joins the team for certain illnesses and injuries or upon request in a rendezvous procedure [8]. At some locations, an ambulance is directly staffed by an emergency doctor. Since the introduction of the professional title “emergency paramedic” in 2014, the responsibilities of non-medical emergency medical services personnel have been expanded. An amendment to the Narcotics Act in 2023 gave emergency paramedics the legal right to administer opioids independently [9].

Until the amendment to the Narcotics Act, the use of opioids by non-medical emergency service personnel was investigated in projects with good results [10–12].

Since the introduction of the project in our rural emergency medical services, there has been a sharp increase in the number of emergency paramedics authorized to administer analgesia and in the use of opioids. This trend has accelerated further since the requirement for emergency paramedics to request additional assistance by the emergency physicians at the scene was abolished [2]. To our knowledge, this is therefore the first study of the group of inadequately treated patients following the change in the law, comparing the results of pain treatment before and after the amendment.

Aim of the study

The aim of this study was to focus on the group of patients who received inadequate analgesic treatment upon handover at the emergency department with regard to opioid dosages, leading diagnoses and changes in opioid applications after the removal of the requirement for emergency physician consultation.

Methods

The emergency medical services district under investigation covers an area of 1420.34 km² and has a population density of 125/km². The largest city with a primary and specialist care hospital (38337 inhabitants as of September 2024) is located in the southeast of the district.

Four rescue stations and three emergency physician bases ensure emergency medical care for the population (3 emergency physician vehicles, 12 emergency ambulances). An average of 17000 rescue calls and 2700 emergency physician deployments are completed each year (Table 1).

Table 1.

Inadequate pain management

Emergency area
		Total population				177 025 (31. Dez. 2024)
		Population density				125/km²
		Ambulance missions/year				ca. 17.000
		Emergency physician missions/year				ca. 2700
		Number of ambulances				12 (81emergency ambulances + 4² patient transport vehicle with extended skills)
		Number of emergency physician vehicles				3³
Study cohort and mission times
NRS h > 4 (n=304/26.5%)						Span: 9 – 95 years				p = 0.895
		M: 55.3 ± 21.0 (n=147/48.4%)
		W: 54.9 ± 21.3 (n=157/51.6%)
		Time on scene				31.8 ± 12 min
		Time with patient				53.6 ± 17.7 min
Opioids				NRSiM ± SD	NRShM ± SD			Dosage PMM ± SD	Dosage EPM ± SD		Total dosage M ± SD
				8.9 ± 1.1	5.8 ± 1.2
Fentanyl (n=243/79.9%)					5.8 ± 1.1		p =0,723	0.159 ± 0.08mg	0.02 ± 0.06mg		0.18 ± 0.1mg (0.025-0.6/p=0.121)
Morphine (n=31/10.2%)					6.4 ± 1.4			4.8 ± 2.5mg	3.8 ± 4.9mg		6.8 ± 5.0mg (2-20mg/p=0.003)
Combination (n=30/9.9%)
					NRS=5 (n=169/55.6%)NRS=6 (n=69/22.7%)NRS=7 (n=30/9.9%)NRS=8 (n=22/7.2%)NRS=9 (n=11/3.6%)NRS=10 (n=3/1.0%)
NRSh≤ 4 (n=843/73.5%)				8.3± 1.3p<0.0001	2.9 ± 1.1p=0.0004
Fentanyl (n=679/80.5%)								0.152± 0.08mg	0.019±0.05mg		0.17± 0.1mg (0.025-0.9mg)
Morphine (n=80/9.5%)								3.1± 1.5mg	1.1± 2.2mg		4.3 ± 2.9mg (1 – 15mg)
Combinations (n=84/10.0%)
Symptom groups
Trauma pain	(n=130/42.8%)				5.8 ± 1.2 p=0.000029 (negative assosiation)
Thoracic pain	(n=16/5.3%)				5.7 ± 0.7
Visceral pain	(n=67 /22.0%)				6.1±1.4 p=0.00024 (positive assosiation)
Colic	(n=13/4.3%)				5.8 ± 1.1
Back pain	(n=54/17.8%)				5.8 ± 1.1
Other pain	(n=24/7.9%)				5.5 ± 0.7 p=0.0031 (positive assosiation)
Diagnosis groups / accident mechanisms
Acute coronary syndrome			(n=12/3.9%)		5.7 ± 0.7
Acute abdomen			(n=79/26.0%)		6.1 ± 1.4
	Morphine (n=19/24.1%)				6.8 ± 1.6			5.1 ± 2.6mg	3.4 ± 4.2		7.1 ± 2.6 (2-20mg)
	Fentanyl (n=47/59.5%)				5.9 ± 1.3 p=0.017			0.16 ± 0.07mg	0.08 ± 0.08		0.18 ± 0.08 (0,025-0,4mg)
	Combination* (n=13/16.4%) (fentanyl / morphin + metamizole and/or butylscopolamine)
Other thoracic pain			(n=3/1.0%)		6.0 ± 1.0
Other accident			(n=19/6.3%)		5.7 ± 1.3
Fall			(n=84/27.6%)		5.7 +- 1.2
	Fentanyl (n=84/100%)							0.17 +- 0.08mg	0.05 +- 0.09mg		0.20 +- 0.12 (0.05-0.6)
		femoral neck/femur fracture (n=28 /21.5%)			5.6 ± 1.2			0.16 +- 0.08mg	0.06 +- 0.1mg		0.20 +- 0.13 (0.05-0.5)
Burns/scalds			(n=2/0.7%)		5.5 ± 0.7			0.15 ± 0.07mg	0.05 ± 0.08mg		0.18 ± 0.09mg (0.05-0.35)
Traffic accident			(n=21/6.9%)		6.0 ± 1.5			0.16 ± 0.09mg	0.08 ± 0.08mg		0.18 ± 0.11mg (0.05-0.5)
Lumbago			(n=52/17.1%)		5.8 ± 1.1			0.16 ± 0.08mg	0.08 ± 0.08mg		0.18 ± 0.11mg (0.05-0.5)
		Lumbar spine syndrome (n=40/76.9%)			5.7 ± 1.0			0.16 ± 0.13mg	0.08 ± 0.09mg		0.19 ± 0.13mg (0.05-0.5)
		Herniated vertebral disc (n=12/23.1%)			6.1 ± 1.4			0.16 ± 0.13mg	0.08 ± 0.09mg		0.19 ± 0.13mg (0.05-0.5)
Others			(n=32/10.5%)		5.6 ± 0.8

NRS = numeric rating scale; i = at initial contact with patient; h = at handover in the hospital; EP = emergency physician; PM = paramedic; M = mean; SD = standard deviation

*Morphine always as a combination partner; ¹ = RTW (german); ² = NKTW (german); ³ = NEF (german)

The project for independent analgesia with opioids by emergency paramedics was introduced at our site in 2014. At that time, the prerequisite for certification was, in addition to self-study, participation in an 8-hour course and passing a final exam, which had to be repeated every two years.

Since the implementation of the amendments to the Narcotics Act 2023, training in opioid administration has become part of the standard training for paramedics, with the examination and issuance of the certificate of competence continuing to take place every two years.

Analgesic therapy with opioids is carried out in accordance with a “severe pain” algorithm, which is revised every two years.

Since the start of the project, morphine has been the first-line treatment for severe abdominal pain. Following the interim evaluation, fentanyl was approved for this indication in April 2022. Since January 2023, the indications for morphine have been limited to “respiratory failure” and “cardiac pulmonary edema” for the purpose of sedation. From this point onwards, all patients with severe and extreme pain, regardless of the cause, were treated with fentanyl by emergency paramedics.

In the current version of the algorithm, morphine is administered in a dosage of 2–3 mg and fentanyl in boluses of 0.1 mg every 3 min with the goal of an NRS ≤ 3 (maximum dose: fentanyl 0.3 mg, not defined for morphine). The timeline of the respectively applicable algorithms is summarized in Fig. 1.

Fig. 1.

Project development timeline

The use of opioids was documented in standard emergency medical service protocols (DIVIDOK^® version EPRO-01030801 as well as DIVI versions 6.0), the evaluation of which is part of the quality management of our emergency medical services.

Pain intensity is recorded using the Numerical Rating Scale (NRS), where 0 corresponds to no pain, 1 to 4 to a tolerable level of pain, and 10 to the maximum conceivable pain. Inadequate pain management corresponds to an NRS value of more than 4 upon handover at the hospital.

The categorization of the missions was done according to symptom groups (trauma pain, thoracic pain, visceral pain, colic, back pain and other pain), according to diagnosis groups or accident mechanisms (acute coronary syndrome, acute abdomen, lumbago, other thoracic diseases, traffic accident, other accident, fall, burns/scalds and others) as described previously [2].

Opioid therapy was recorded in three groups (fentanyl, morphine and combinations), with the opioid initially administered by the emergency paramedics defining the assignment to the corresponding group.

The primary outcome was the amount of opioids administered to patients with NRS > 4 in comparison to patients with low pain levels at handover in the hospital. The secondary outcomes encompass the proportion of undertreated patients both pre- and post-regulatory / protocol changes, the diagnosis groups at risk of being undertreated, vital signs and the adverse effects resulting from the treatment.

All analgesics were administered via adequate intravenous access.

Statistical methods

Data sets with incomplete documentation of dosages were excluded from the group analysis. Statistical analysis of the data was performed using IBM SPSS Statistics for Windows, version 27 (IBM Corp., Armonk, N.Y., USA).

Data was tested for normal distribution using the Kolmogorov-Smirnov and Shapiro-Wilk test.

Respiratory rate, systolic blood pressure, heart rate and peripheral oxygen saturation before and after treatment with opioids were compared using the Wilcoxon signed-rank test. The differences in pain levels at initial contact and upon handover at the emergency department as well as the average doses of opioids in two groups (NRS ≤ 4 versus NRS > 4) were calculated using the Mann–Whitney U test.

Correlation between the degree of pain reduction and the choice of opioid, the dosage administered, the presence of the emergency physician at the scene, additional analgesia and the emergency physician accompanying the patient to the hospital was tested by means of regression analysis.

Standard cut-off p-value was set to < 0.05. The analysis of the association between symptom groups, accident mechanisms, NACA-score, illness/injury groups and analgesic therapy was performed using the chi-square test and the significance level (p-value) for multiple comparisons within the test was adjusted using Bonferroni correction.

Ethics approval

The study was conducted following approval by the Ethics Committee of the Lower Saxony Medical Association (statement by the Ethics Subcommittee of the Lower Saxony Medical Association dated 12 January 2017).

The study has been performed in accordance with the Declaration of Helsinki. All methods were carried out in accordance with relevant guidelines and regulations in the declaration.

Results

Between 1 January 2016 and 14 October 2024 1235 patients were primarily treated with opioids by emergency paramedics (with and without an emergency doctor arriving later), of whom 1147 (92.9%) could be evaluated.

Patient characteristics and key response times are summarized in Table 1. The average time spent at the scene was 31.8 ± 12 min and the time spent with the patient (from arrival to handover at the hospital) was 53.6 ± 17.7 min.

The target NRS of ≤ 4 was achieved in 843 patients (73.5%). In 26.5% (n = 304) of the cases, the specified target NRS was not achieved, so that insufficient pain treatment can be assumed (Table 1).

The average pain level of inadequately treated patients upon admission to hospital was NRS 5.8 ± 1.2 compared to 2.9 ± 1.1 in patients who achieved the target NRS (p < 0.0001). An NRS of 5 (55.6%, n = 169) and 6 (22.7%, n = 69) accounted for 78.3% of all cases in these patients. The remaining patients (21.7%, n = 66) suffered from the most severe pain, defined as NRS > 6 (Fig. 2).

Fig. 2.

NRS at handover at the hospital

The baseline pain level of these patients, NRS 8.9 +- 1.1, was significantly higher than that of patients who achieved the target NRS (8.3 +- 1.3; p < 0.0001) (Fig. 3).

Fig. 3.

Baseline pain level at first contact

The average pain reduction in the entire cohort was 4.8 ± 1.9. In patients with inadequate analgesia upon admission to the hospital, this was significantly lower at 3.1 ± 1.5 than in the group with NRS < 4 (5.5 ± 1.6; p < 0.0001).

All patients were assigned to either the ‘illness’ category (40.2%/n = 461) or the ‘injury’ category (59.8%/n = 686). The target NRS was significantly less frequently achieved in the group of patients with illnesses (illness: n = 140/30.4%; injury: n = 164/23.9%; p = 0.015). Higher NACA-score (severity of the illness or injury) was also associated with inadequate analgesia (p = 0.037) at handover at the hospital.

Analgesics

In our patient population, the opioid fentanyl was used as the sole agent in a total of 80.4% of cases (n = 922), morphine alone in 9.7% of cases (n = 111) and combination therapy (fentanyl and/or morphine + metamizole and/or butylscopolamine and/or esketamine) in 9.9% (n = 114).

In the group of patients with inadequate analgesic therapy, fentanyl alone was used in 79.9% of cases (n = 243), morphine in 10.2% (n = 31) and combination therapy (fentanyl and/or morphine + metamizole and/or butylscopolamine and/or esketamine) in 9.9% (n = 30) of cases.

With regard to the frequency of inadequate pain therapy (NRS > 4), there was no significant difference between the two opioids fentanyl and morphine in the entire patient population (p = 0.723) (Table 1).

However, in the group of inadequately treated patients, significantly lower handover NRS values were observed with fentanyl compared to morphine (NRS = 5.8 ± 1.1 vs. NRS = 6.4 ± 1.4, p = 0.004) (Fig. 4).

Fig. 4.

NRS at handover morphine versus fentanyl

Fentanyl

The mean total dose of fentanyl administered to patients with NRS > 4 (n = 243) at handover was 0.18 mg ± 0.1 mg (min. 0.025 mg, max. 0.6 mg), in the group of patients with NRS < 4 (n = 679) 0.17 mg ± 0.1 mg (min. 0.025, max. 0.9 mg/p = 0.121) (Fig. 5).

Fig. 5.

Amount of fentanyl administered by paramedics and emergency physicians

A mean of 0.16 mg ± 0.08 mg fentanyl was administered by the emergency paramedics (patients with NRS < 4: 0.15 mg ± 0.08 mg/p = 0.117) and an additional 0.05 mg ± 0.08 mg was administered by the emergency physicians (patients with NRS < 4: 0.035 mg ± 0.07 mg/p = 0.026) (Table 1).

Analgesic therapy with fentanyl administered exclusively by emergency paramedics was used in 49.6% (n = 463) of cases, with no significant difference (p = 0.942) in the dose administered between patients who achieved the target NRS (n = 327, 0.155 ± 0.078 mg) and patients with persistent severe pain (n = 136; 0.156 ± 0.082 mg) upon handover at the hospital (Fig. 6).

Fig. 6.

Amount of fentanyl administered by paramedics (no EP at the scene of emergency)

In the entire patient population treated with fentanyl (n = 922), the maximum permitted dose of 0.3 mg fentanyl was reached by emergency paramedics in 12.1% (n = 112 cases) and exceeded in 1.6% (n = 15). Overall, 0.3 mg of fentanyl was exceeded by emergency paramedics and emergency physicians in 6.9% (n = 64) of cases.

In the group of inadequately treated patients (n = 243), a maximum up to 0.2 mg of fentanyl was administered by emergency paramedics in 85.2% of cases (n = 207) and between 0.2 mg and 0.3 mg of fentanyl in 12.8% (n = 31) of cases. In 2.1% (n = 5) of cases, the maximum dose of 0.3 mg fentanyl was exceeded. In collaboration with emergency physicians, more than 0.3 mg fentanyl was administered in 8.2% (n = 20) of cases. Failure to achieve target NRS at hospital transfer was not associated with a significantly higher dose of fentanyl (p = 0.357).

In the group of patients with NRS > 4 on arrival at the hospital, no antagonisation of the fentanyl effect with naloxone was necessary, in one case (0.4%) temporary mask ventilation was necessary and in 4 cases (1.6%) the patients were temporarily asked to breathe (so-called command breathing). Mask ventilation, antagonisation of the opioid effect or command breathing was not necessary in any of the patients who received more than 0.3 mg fentanyl (Table 2).

Table 2.

Vital parameters of patients before and after analgesia and adverse effects

Vital parameters	N	Min	Max	M	SD	p-values	Adverse effects
RRi	288	10	42	16	3	< 0.001		NRSh ≤ 4 n = 843	NRS h > 4 n = 304
RRh	274	9	22	14	2		Command breathing	n = 7 (0.61%)	n = 5 (0.44%)
BPsysi	300	80	217	142	25	< 0.001		P = 0.232
BPsysh	290	80	204	138	22		Temporary mask ventilation	n = 1 (0.09%)	n = 2 (0.2%)
HRi	303	42	160	87	20	< 0.001		P = 0.115
HRh	303	40	150	82	17
spO2i	301	84	100	97	3	0,45	Antagonization of opioids	n = 0	n = 0
spO2h	300	80	100	97	3

RR = respiratory rate; BPsys = systolic blood pressure, HR = heart rate; spO2 = oxygen saturation; NRS = numeric rating scale; i = at initial contact with patient; h = at handover in the hospital; M = mean; SD = standard deviation

Morphine

In the group of patients with NRS > 4 upon arrival at the hospital, the opioid morphine (n = 31) was administered by the emergency paramedics in a mean dose of 4.6 ± 2.5 mg (min. 2 mg, max. 10 mg; patients with NRS < 4: 3.1 mg ± 1.5 mg, p = 0.003). The emergency physicians administered an additional average of 3.8 ± 4.9 mg. Overall, these patients received an average of 6.8 ± 5 mg (min. 2 mg, max. 20 mg) of morphine.

Mask ventilation was necessary once after the administration of morphine, antagonisation of the opioid effect was not necessary in any case (Table 2).

Vital signs

Analgesic therapy resulted in a significant reduction in systolic blood pressure (initial 142 mmHg ± 25.6mmHg vs. 138 mmHg ± 21.5mmHg on admission to hospital; p < 0.001), pulse (initial 87/min ± 20/min vs. 82/min ± 17/min on handover at the hospital; p < 0.001) and respiratory rate (16/min ± 3/min vs. 14/min ± 2/min upon handover; p < 0.001), while spO2 remained unchanged at 97% ± 2% (97% ± 2% both initially and upon handover; p = 0.45) (Table 2).

Emergency physician treatment and transportation

In the group of patients who received inadequate analgesia, the emergency physician was not present at the scene in 52.0% of cases (n = 158). In 48.0% of the cases (n = 146), the emergency physician was present at the scene of the emergency, but additional analgesia was provided by the physician in only 24% (n = 73) of the cases and only 14.1% of the patients (n = 43) were accompanied to the hospital.

The presence of the emergency physician at the scene of the emergency had no influence on the handover NRS in the hospital in the group of inadequately treated patients (EP on site: 5.8 ± 1.2; only PM on site: 5.9 ± 1.2; p = 0.497).

Symptom and diagnosis groups in cases of inadequate pain management

The majority of the patients with insufficient pain management were assigned to the symptom groups “trauma pain” (42.8%, n = 130, NRS handover: 5.8 ± 1.2) followed by “visceral pain” (22.0%, n = 67, NRS handover: 6.1 ± 1.4) and “back pain” (17.8%, n = 54, NRS handover: 5.8 ± 1.1), the injury pattern “fall” with 27.6% (n = 84, NRS handover 5.7 ± 1.2), the diagnosis fields “acute abdomen” with 26.0% (n = 79, NRS handover 6.1 ± 1.4) and “lumbago” with 17.7% (n = 54, NRS handover: 5.8 ± 1.1) were leading (Table 1).

The highest NRS values upon admission to hospital were found in the diagnostic complex ‘acute abdomen’ (NRS 6.1 ± 1.4) and the trauma mechanism ‘traffic accident’ (NRS 6.0 ± 1.5).

In the entire patient population, the diagnosis groups ‘visceral pain’ (p = 0.00024) and ‘other pain’ (p = 0.0031) were significantly more frequently associated with failure to achieve the target NRS than other diagnosis groups. Trauma, as the largest group with an indication for analgesic therapy, was significantly less frequently associated with failure to achieve the target NRS (p = 0.000029) (Table 1).

There was no correlation between the degree of pain reduction and the choice of opioid, the dosage administered, the presence of the emergency physician at the scene, additional analgesia or the emergency physician accompanying the patient to the hospital, either in the patient group as a whole or in the two pain groups.

Inadequate analgesia for acute abdomen

No statistically relevant statements could be made about the specific diagnoses of patient with acute abdomen.

24.1% of patients (n = 19) were treated with morphine and 59.5% (n = 47) with fentanyl, with fentanyl showing an advantage in terms of the handover NRS (NRS 5.9 ± 1.3) compared to morphine (NRS 6.8 ± 1.6; p = 0.017). The mean dose of morphine administered by paramedics was 5.1 ± 2.6 mg, and emergency physicians administered a mean additional 3.4 ± 4.2 mg. The mean total dose of morphine administered was 7.1 ± 2.6 mg (min 2, max 20 mg).

In patients with acute abdomen treated with fentanyl, emergency paramedics administered an average of 0.16 ± 0.07 mg fentanyl, emergency physicians an additional 0.08 mg ± 0.08 mg and a total mean of 0.18 mg ± 0.08 mg (min. 0.025 and max. 0.4 mg) fentanyl (Table 1).

In the group of patients with acute abdomen, command breathing was necessary twice, mask ventilation or antagonisation of the opioid effect was not necessary.

Inadequate analgesia in trauma

All 130 (of a total of 608) traumatised patients with inadequate pain management (NRS > 4 at handover) were treated with fentanyl. The most common mechanism of trauma in this group was “fall” (64.6%, n = 84, NRS handover 5.7 ± 1.2) followed by “traffic accident” (16.2%, n = 21, NRS handover 6.0 ± 1.5) and the most common diagnosis was “femoral neck/femur fracture” (21.5%, n = 28). The mean dose of fentanyl administered by emergency paramedics in femoral neck/femur fracture was 0.16 mg ± 0.08 mg, by emergency physicians an additional 0.06 mg ± 0.09 mg and a total dose of 0.20 mg ± 0.11 mg (min. 0.05 mg and max. 0.6 mg) fentanyl (Table 1).

Back pain

In the group of patients with back pain (n = 54), the most common diagnosis was ‘lumbago’ at 74.1% (n = 40), followed by herniated discs at 22.2% (n = 12). All patients in this diagnostic group were treated with fentanyl. Paramedics administered an average of 0.16 ± 0.09 mg of fentanyl, and emergency physicians administered an additional 0.08 ± 0.08 mg of fentanyl for a total dose of 0.18 ± 0.11 mg (min. 0.05, max. 0.5).

Command breathing was used in 3.7% of cases (n = 2) and mask ventilation or antagonisation was not necessary (Table 2).

Overall there was no increase in side effects in inadequately treated patients compared to patients who achieved the target NRS (Table 2).

Amendment to the law and abolition of the requirement for an emergency doctor’s request

In 2023, the legal basis for handling narcotics was amended in Germany, creating a legal option for paramedics to administer this therapy without having to call for an emergency physician to the scene. The regional algorithms were then adjusted accordingly [9].

70.3% of the patients examined here (n = 807) were treated by emergency paramedics before the implementation of the legal change in the regional algorithms and 29.7% (n = 341) after the change in the legal basis. With a relative proportion of inadequately treated patients of 32.6% in 2024, there was a significant increase in inadequate treatment after the abolition of the requirement to call an emergency doctor (p = 0.045) (Fig. 7 and Fig. 8).

Fig. 7.

Inadequately treated patients over the years

Fig. 8.

Inadequately treated patient before and after amendment to legislation

Discussion

In our cohort, 26.2% of patients with an NRS > 4 at handover in hospital were inadequately treated with analgesics. Other studies also showed a similar proportion of undertreated patients in prehospital setting [13–16].

A higher initial pain level was associated with more severe pain during handover and failure to achieve the target NRS. Most patients had handover NRS scores that were 1 or 2 points above the target NRS. Oberholzer et al. were able to show that a higher baseline pain level, higher NACA classification and non-traumatic pain were associated with higher NRS scores at hospital handover [15]. In our work, higher NACA scores and non-traumatic pain were also associated with higher pain levels at handover.

While failure to achieve the target pain level of 4 or less was independent of the type of opioid selected, fentanyl showed an advantage over morphine in this group in terms of pain intensity at handover. This result is interesting because our regional algorithms specify a maximum dose of 0.3 mg for fentanyl therapy by paramedics, while no limit has been defined for morphine. The dose of fentanyl administered by paramedics showed no significant difference between patients who achieved the target NRS and those who still had severe pain on arrival at the hospital. On the part of the emergency physicians, the difference in dosage was small but significant. It would be expected that patients with more pain would receive a higher total dose of fentanyl, but this was not the case.

Unlike fentanyl, emergency paramedics actually administered a significantly higher dose of morphine to patients with an NRS > 4 upon arrival at the hospital, although in no case was the dose higher than 10 mg, which may be necessary, especially in patients with more severe pain. The reasons for this cannot be determined from the data. Teoh et al. identified interprofessional relationships, knowledge deficits, stress, anxiety and inadequate guidelines as causes of prehospital oligoanalgesia [17]. In our procedures/algorithms, we would critically question whether clearer/more precise dosage instructions would have led to an increase in the amount of opioids administered. This might have reduced the fear of overdose ‘without backup’ associated with the new ‘rule on not requesting emergency doctors’ assistance.

The proportion of patients treated with morphine is relatively low in our study. This can be attributed to the modification of local algorithms in the context of the interim evaluation of results, which has led to a restriction in the utilisation of morphine to cases of ‘respiratory insufficiency’ and ‘cardiac pulmonary oedema’ [2].

An alternative method for analyzing effective analgesia is to evaluate the degree of pain reduction after therapy. A difference of ≥ 2 points on the NRS scale (before and after analgesic therapy) is considered a significant reduction in pain.

Both in the entire patient cohort and in the group of inadequately treated patients, a significant pain reduction of more than 2 points was achieved on average. This result is encouraging and alarming at the same time, as a pure analysis of pain reduction would mean that a significant proportion of patients experiencing persistent severe pain upon admission to hospital would not be recognised.

The requirements for analgesic substances in prehospital pain management include sufficient analgesic potency, rapid onset of action, a wide therapeutic range and the greatest possible safety for the patient and the healthcare provider.

The substances most commonly used in Germany are the opioids fentanyl and morphine, as well as the non-opioid analgesic esketamine/ketamine, which is administered in combination with midazolam [18]. Particularly with regard to the potentially critical side effects in the absence of an emergency physician at the scene (complete treatment of the patient by emergency paramedics), the choice of the appropriate analgesic is a subject of ongoing debate. While supporters of esketamine/midazolam therapy highlight respiratory and circulatory depression, nausea and vomiting associated with the use of opioids as the most important counterarguments, the pro-opioid groups emphasize the reduction in consciousness, the risk of psychomotor side effects, the impossibility of antagonizing esketamine therapy and, ultimately, the necessary readiness to secure the airway when administering higher doses of esketamine/ketamine [2, 19]. In a retrospective patient survey conducted after low-dose esketamine/midazolam therapy, Häske et al. demonstrated a low level of side effects and high patient satisfaction [20].

Friesgard et al. demonstrated high effectiveness and low side effect rates in therapy with fentanyl [21]. Our research team has proven the high effectiveness and safety of these substances in the context of opioid therapy by emergency paramedics since 2016 [2]. In summary, the choice between fentanyl/morphine and esketamine/metamizole appears to be a matter of the clinical experience of the emergency medical services personnel in the respective emergency medical services area in dealing with one or the other group of analgesics. The results of the currently ongoing double-blind randomized FORE-PAIN study, which compares treatment with fentanyl and ketamine for traumatic pain, could be interesting in this context [22].

One substance that is not yet widely used in Germany is the opioid analgesic nalbuphine, which, due to its agonistic effect on the ƙ receptor and partial antagonistic effect on the µ receptor, does not cause respiratory depression and has a wide therapeutic range due to its ceiling effect. Deslandes et al. compared treatment with nalbuphine + paracetamol versus treatment with morphine alone by emergency paramedics and were able to demonstrate higher efficacy and a lower complication rate with nalbuphine. However, the proportion of patients who did not achieve the target NRS of < 4 was even higher than in our own study (51.3% in the nalbuphine + paracetamol group and 80.4% in the morphine group). The main reason for these results was most likely a low total dose of nalbuphine and morphine in both groups [23]. The use of nalbuphine in patients with chronic opioid consumption can trigger withdrawal symptoms and is therefore not recommended.

The effects of nalbuphine were primarily studied in the 1980s. The ability of this substance to reverse fentanyl-induced respiratory depression while, unlike naloxone, continuing to provide adequate analgesia was demonstrated by the group of Bailey et al. [24]. Consequently, nalbuphine could potentially be considered as the treatment of choice for fentanyl overdose in emergency medical services.

The application of combinations involving opioids and co-analgesics is another interesting and promising approach. Studies from the perioperative setting have shown an opioid-sparing effect for several classes of substances. While the addition of ketamine in the perioperative setting has led to controversial results, it appears to have a positive effect on postoperative pain in certain surgical procedures. The addition of paracetamol is generally considered to be a beneficial and safer treatment method [25]. The Italian Intersociety Group on Pain Management in the Emergency Setting recommends the use of paracetamol for opioid-sparing effect at Level A. At the same time, the same group warns of potential adverse effects when ketamine is added [19]. In the pre-hospital setting, another group highlights unclear risks associated with combining ketamine and morphine [26].

Emergency physician treatment and transportation

In the group of patients, who were still suffering from severe pain when handed over to the hospital, the emergency doctor was on site in approximately half of the cases, but this didn’t affect the handover NRS. The reasons for this aren’t clear. The emergency physicians administered only small amounts of opioids in addition to the opioid doses already administered by the paramedics. Thomas et al. showed in a recent study that emergency physicians achieved greater pain reduction than paramedics [27]. This result could not be confirmed in our study for the group of patients who received inadequate treatment. Despite inadequate analgesia, only 14.1% of patients were accompanied to hospital by emergency doctors. The project for independent analgesia by emergency paramedics was established at our site 10 years ago and has been widely accepted by emergency physicians [12]. It is therefore conceivable that the presence of doctors was often only for formal reasons (requirement for additional documentation when opioids were administered) and that responsibility for further analgesic therapy was transferred to the paramedics in most cases.

With an average attendance time of 53.6 min for emergency medical services personnel (time at the scene plus transport time), reduced by 10 min for initial assessment and establishment of intravenous access, there was a sufficient time interval for titration of fentanyl to the maximum dose of 0.3 mg, regardless of the protocol used. In the group of patients treated with morphine (maximum dose not specified), we would also have expected significantly higher doses to be applied.

Patient groups

Visceral pain

In our study, abdominal pain showed the highest NRS value at handover in hospital and was highly significantly associated with failure to achieve the target NRS. Galinski et al. showed that abdominal pain is more often associated with inadequate analgesic treatment [14]. Magnusson et al. recorded the pain level after analgesic therapy of hip, thorax and abdominal pain in 1234 patients. The study showed the highest success rate of therapy for hip pain (80%) and the lowest for visceral pain (43%) [28].

As in the entire patient population, fentanyl also showed an advantage over morphine in the treatment of abdominal pain. Häske et al. investigated the success rate of abdominal pain therapy with fentanyl, morphine, metamizole and ketamine in 129 patients. They found that fentanyl and ketamine were significantly more effective (92.9% and 92.6%) than other substances [29]. In their meta-analysis, Sobieraj et al. were able to show that in cases of inadequate analgesia with morphine, combining it with ketamine can lead to better and faster pain reduction than further administration of morphine. However, they also pointed out potentially incalculable risks [26].

An evidence-based recommendation for prehospital analgesic therapy published in 2023 by Lindbeck et al. recommended monotherapy with either ketamine or opioids and against a combination of both substances. The group also pointed out the challenge of calculating weight-adjusted dosages [30]. On the other hand, studies conducted in recent years show that the use of low-dose esketamine in the perioperative setting leads to savings in opioids and better postoperative analgesia [31–34].

Traumatic pain

In the present work, trauma was the most frequent indication for analgesic therapy at the site of emergency. Although inadequate analgesia in traumatised patients did not occur significantly more frequently in the entire patient population than in other groups, this patient population represents the largest population with inadequate pain management and thus the greatest potential for improvement. In the group of traumatised patients, emergency paramedics and emergency physicians also failed to achieve the maximum dose of fentanyl. Friesgaard et al. were able to achieve lower pain levels in their study by using an analgesia protocol that allowed emergency paramedics to administer higher doses of fentanyl [21]. However, the maximum dose in this study was calculated based on patient weight and, at 3 µg/kg bodyweight, was below the dosage of 0.3 mg approved by us in the liberal protocol for normal-weight adults weighing approximately 80 kg [21].

In addition to utilising the prescribed opioid dosages, the use of other painkillers (e.g. esketamine) or alternative analgesic methods (regional anaesthesia) should be discussed. While analgesia with esketamine is routinely administered by emergency paramedics in Germany, the use of regional anaesthesia procedures is an exception [10, 27, 35].

In femoral neck fractures, techniques such as fascia iliaca compartment block is a possible alternative to intravenous opioid therapy with a significant reduction in pain and low potential for side effects [36, 37]. In recent years, ultrasound-guided PENG nerve block has become established in our department for the treatment of proximal femoral fractures close to the joint, with very good results [38]. Pre-hospital application of that technique could potentially be a very good alternative to opioid therapy when an emergency doctor who routinely uses that method in hospital is present at the scene.

Back pain

Back pain represented another large group of patients with persistently high levels of pain at handover in hospital. In a meta-analysis, the working group led by Fichtner et al. reported advantages of modern regional anaesthesia procedures in emergency departments and in some situations in the pre-hospital setting over opioid therapy for back pain [39].

All regional anaesthesia procedures in the prehospital setting require a high level of expertise on the part of the emergency personnel at the scene, which is rarely available among medical personnel.

In addition to the legal uncertainties, the training required to learn the procedures for the entire group of emergency paramedics would be enormous and very difficult to implement.

Abolition of the requirement for an emergency doctor’s request

With the implementation of the legislative change for emergency paramedics, the pain therapy algorithms at our site were adjusted. The initial dose of fentanyl for adult non-geriatric patients was increased from 0.05 mg to 0.1 mg and the interval until the repeat dose was shortened from 5 to 3 min. The aim of the changes was to prevent underdosing by emergency paramedics and reduce the proportion of inadequately treated patients. Despite this adjustment to the algorithm, the proportion of inadequately treated patients increased.

It is possible that the abolition of the fallback level (emergency doctor) has led to a disproportionate increase in the level of responsibility for the administration of high doses of opioids. In addition to the formulation of dose and interval limits, an algorithm that includes ‘adequate analgesia’ is required.

Regular automated feedback on the results of analgesic therapy for each individual emergency paramedic could potentially improve analgesia in the emergency medical services.

Conclusions

1. Approximately one quarter of patients treated had excessive pain levels of NRS > 4 upon handover in hospital.

2. Insufficient titration and/or limited dose escalation of opioids by paramedics and emergency physicians seems to be the important contributor to inadequate treatment.

3. The proportion of inadequately treated patients rose significantly following the suspension of the obligation to call an emergency doctor to the scene.

4. The implementation of a feedback system with the objective of optimising opioid-based analgesia by emergency paramedics may result in a reduction in the proportion of patients who remain undertreated.

5. A use of Co-Analgetics (e.g. Paracetamol) might lead to opioid-sparing effect and improvement of pain level at handover at the hospital (Table 3).

Table 3.

Practice implications box

Practice implications box
For paramedics:	For medical directors:
Pain: Adults ≥ 7 years and NRS ≥ 6 Fentanyl: initial 0.1 mg, rep. 0.05-0.1 mg, interval: 3 min, max. dose 0.3 mg Stick to the algorithm for target-NRS ≤ 4 If NRS > 4 and max. dosage reached → request telemedical support or EP to scene	Process: Evaluate Patients with NRS > 4 at handover regularly (dosing of opioids, adverse effects) Consider implementing automated routines for evaluation Provide personal feedback to paramedics if necessary (delegate if apropriate)
Sedation (dyspnea e.g. in cardiac decompensation or COLD exacerbation): Morphin: initial 2-3 mg, rep. 2-3 mg, interval 3–5 min., unlimited max. dose EP request according to local algorithms	Analgesics Consider Combination of Opioid with Non-Opioid (e.g. paracetamol)

Abbreviations

NRS

Numeric rating scale

NRSⁱ

Numeric rating scale at initial contact with patient

NRS^h

Numeric rating scale at handover in the hospital

EP

Emergency physician

PM

Emergency paramedic

RRⁱ

Respiratory rate at initial contact

RR^h

Respiratory rate at handover in the hospital

BPsysⁱ

Systolic blood pressure at initial contact

BPsys^h

Systolic blood pressure at handover in the hospital

HRⁱ

Heart rate at initial contact

HR^h

Heart rate at handover in the hospital

spO2ⁱ

Oxygen saturation at initial contact

spO2^h

Oxygen saturation at handover in the hospital

NACA

National Advisory Committee for Aeronautics score

PENG

Pericapsular nerve group

BtMG

Narcotic act

COLD

Chronic Obstructive Pulmonary Disease

Author contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Data availability

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Declarations

Ethical approval

The Ethics Committee of the Lower Saxony Medical Association gave a positive vote for the retrospective evaluation of the anonymised intervention data (statement by the Ethics Subcommittee of the Lower Saxony Medical Association dated 12 January 2017): In the opinion of the Subcommittee for the Assessment of Medical Research Involving Human Subjects of the Ethics Committee at the Medical Association of Lower Saxony (ÄKN), the retrospective data evaluation planned by us is not a research project in which the psychological or physical integrity of a human being is interfered with or body materials or data are used that can be assigned to a specific human being. The study has been performed in accordance with the Declaration of Helsinki. All methods were carried out in accordance with relevant guidelines and regulations in the declaration.

Consent for publication

Not applicable.

Consent to participate

Waived by an ethics committee: “Provided that the personal patient data do not leave the circle of physicians who are obliged to remain silent anyway and who are involved in the treatment of the patient, including auxiliary staff, consultation with the ethics committee in accordance with § 15 of the professional regulations of the ÄKN is therefore not necessary. We strictly adhered to all provisions.”

Competing interests

The authors declare no competing interests.