ABSTRACT
Aim:
The aim of the present study was to compare the pain intensity due to intravenous injection of sodium thiopental, propofol, diazepam, and etomidate during the induction of general anesthesia.
Methods:
This was a non-controlled quasi-experimental double-blinded study performed on eligible patients referred to the operating room of Shahid Beheshti Hospital in Yasouj. A total of 200 patients were randomly selected by convenience sampling and based on a table of random numbers generated on a computer. They were then randomly divided into four intervention groups based on random blocks (sodium thiopental, propofol, etomidate, and diazepam). Finally, the collected data were analyzed using descriptive as well as analytical statistical tests such as Chi-square, analysis of covariance (ANCOVA), and Bonferroni post hoc test were analyzed in SPSS ver. 24.
Results:
The results of the present study showed that the diazepam group experienced the highest pain intensity (8.42) compared to other groups, which was statistically significant (P = 0.001). Also, the sodium thiopental group experienced the highest pain (6.92) after the diazepam group, which was also statistically significant as compared to the other remaining two groups (P = 0.001). Propofol and etomidate groups experienced the lowest pain intensity (3.30 and 3.26, respectively).
Conclusion:
The present study revealed that the use of diazepam and sodium thiopental as anesthetic drugs was generally associated with greater pain intensity during injection and less hemodynamic stability. The results of the present study indicated that propofol and etomidate are preferred over diazepam and sodium thiopental in abdominal and gastrointestinal surgeries, considering their less pain intensity and fewer hemodynamic changes.
Keywords: Diazepam, etomidate, pain, propofol, sodium thiopental
Introduction
Induction of anesthesia is the first stage of general anesthesia. It is a very important and vital stage before surgery. Before induction of anesthesia, the patient undergoes complete monitoring, which includes measurement of blood pressure, electrocardiogram (ECG), measurement of arterial oxygen saturation, and heart rate.[1,2] Cardiac arrhythmias,[1] hemodynamic changes,[2,3] and hypotension[3] are some of the events that may occur during the induction of anesthesia and endanger the lives of patients who are diagnosed with the help of monitoring, and treated, if necessary. There are various anesthetic drugs and often belong to benzodiazepines (midazolam and diazepam, barbiturates (sodium thiopental, methohexital), propofol, etomidate (Ding et al. 2021), inhaled anesthetics (isoflurane), neuromuscular relaxants (atracurium), and opioids (fentanyl, sufentanil).[1] The anesthetic drugs are selected based on the patient’s conditions, induction rate, drug recovery, and mechanism of action of the drug.[2,3] Propofol, sodium thiopental, etomidate, and diazepam are among the most widely used drugs in general anesthesia. Propofol, sodium thiopental, and etomidate are among the intravenous anesthetics, and diazepam belongs to the benzodiazepines.[4] Characteristics such as rapid metabolism and high plasma clearance, neuroprotection, anticonvulsant activity, inhibition of upper airway reflexes, anti-nausea and vomiting, and decreased Intracranial pressure (ICP) make propofol and sodium thiopental more popular for use in the induction of anesthesia. Propofol is also used for the maintenance phase of anesthesia.[5-7] Etomidate is used in patients with respiratory and cardiac dysfunction because it has minimal effect on respiratory and cardiac functions and is a short-acting drug.[5,8,9] Benzodiazepines are used as premedications and sedatives to prepare patients for surgery. Properties such as high-fat solubility, favorable side effects, minimal attenuation of respiratory ventilation, and cardiovascular system with controlled doses, induction of forgetfulness during surgery, anti-anxiety, and sedation have led researchers to use this drug as a premedication and anticonvulsant drug.[10,11] One of the common side effects of these four drugs is acute injection pain, which can even cause the patient to react. The injection pain may cause the patient to experience an unpleasant sensory or emotional experience, discouraging the patient from the next re-referrals.[12-15] Many factors affect the incidence of injection pain, which include the injection site, the vein size, the injection speed, the drug concentration, and the blood buffer. Other important factors include the velocity of the intravenous fluid, the drug temperature, the syringe material, and the concomitant use of drugs such as local anesthesia and drugs before injecting the aforementioned drugs.[16,17] Pain and absence of control strategies can lead to patient dissatisfaction, inappropriate patient–nurse communication, and increased treatment costs.[12,18] Pain may be due to the formulation of propylene glycol, which may cause direct damage to the vascular endothelium.[15] Pain sensation has adverse physiological effects such as atelectasis, hypercapnia, systemic hypertension, tachycardia, cardiac dysrhythmia, hyperglycemia, decreased immune function, and urinary retention.[18] The occurrence of any of the above complications during induction of anesthesia can cause irreparable damage to the patient. Various studies have been performed to reduce the sensation of injection pain, such as the use of lidocaine and dexamethasone.[19-21] There have been numerous studies on the prevalence of pain due to the injection of the above drugs, and all of them have confirmed the sensation of injection pain.[5,10,12,14] In another study in 2017, injection pain was reported in the case of sodium thiopental and etomidate, and the intensity of injection pain in the etomidate group was higher than sodium thiopental group.[22] The above studies did not compare pain intensity due to the injection of the above drugs, and such limitation was eliminated in the present study. The above drugs are among the most widely used anesthetic drugs, and attempts should be made to minimize the injection pain in these drugs. Therefore, the aim of the present study was to determine the drug that induces the highest pain intensity during the injection. Therefore, this study was performed to compare the pain intensity due to intravenous injection of sodium thiopental, propofol, diazepam, and etomidate during induction of general anesthesia.
Materials and Methods
This was a non-controlled quasi-experimental double-blind study performed on eligible patients referred to the operating room of Shahid Beheshti Hospital in Yasuj. A total of 200 patients who were candidates for elective abdominal and gastrointestinal surgeries were selected by convenience sampling and randomly based on a table of random numbers generated by computer. They were then randomly divided into four intervention groups using random blocks (sodium thiopental, propofol, etomidate, and diazepam) [Figure 1]. The researcher collected the data, after obtaining the approval of the Medical Ethics Committee of Yasouj University of Medical Sciences, number (IR.YUMS.REC.1398.167), registering the research project in the Iranian Registry of Clinical Trials (IRCT20190822044581N2), obtaining informed and written consent from the samples, and receiving official permissions from relevant officials. The subjects could participate in the study voluntarily, and they were assured that all their information would be kept completely confidential. Inclusion criteria included 1. having general anesthesia conditions based on pre-anesthetic examinations 2. participants aged 15 to 50 years 3. elective surgery 4. ASA class I patients 5. no drug addiction 6. no mental disorders based on pre-anesthetic examinations 7. no diabetes 8. no neuromuscular disorders 9. literacy skills. Exclusion criteria also included 1. patient dissatisfaction and unwillingness to cooperate 2. ASA class > I 3. vascular disorders 4. burns in the upper limbs 5. thrombophlebitis 6. history of chronic pain along with the use of analgesics 7. receiving analgesics within 24 h before surgery. Considering the study objectives and type and based on relevant previous studies taking into account the sample size formula and type I error 5% and 80% power, 43 people were estimated in each group. Considering the possible drop-out, finally, the total sample size was estimated to be 200 (N = 50 people per group).
Figure 1.
Consort flow diagram
Intervention
After obtaining informed consent from patients during the preoperative anesthetic visit, they were explained about the present study and responding to the intensity of pain caused by intravenous injection of anesthetic drugs based on the numeric rating scale (NRS). Eligible patients were transferred to the preoperative waiting room approximately 1 h before the operation. Venipuncture was performed on the back of the hand using an angiocatheter gauge 20, normal isotonic serum was injected at an infusion rate of 300 mL/h, and the demographic questionnaire was completed for each patient. After entering the operating room, patients underwent standard care and monitoring such as ECG, blood pressure, and pulse oximetry. All drugs were labeled and covered in similar and standard 10 mL syringes with special codes. They were prepared at the same temperature (room temperature). The drugs used for each group were prepared by the same pharmaceutical company in Iran. Simultaneously with intravenous injection of the studied drugs by the first anesthesiologist during the induction of anesthesia, the pain intensity was measured by the second anesthesiologist who was not aware of the groups and drugs using NRS, which is a self-report scale, and the intensity of injection pain was determined, accordingly. Patients were asked to give clear responses about pain or discomfort at the injection site in Yes or No format. If there was pain, its intensity was measured based on the NRS and recorded in a questionnaire. No other drugs were injected before the above drugs. Therefore, the pain intensity of each drug was measured based on the intravenous injection of the same drug alone. Sodium thiopental, propofol, diazepam, and etomidate were injected intravenously at doses of 3, 1, 0.1, and 0.3 mg/kg for each group by the first anesthetist upon induction of anesthesia. The volume of all drugs was increased to 10 mL. All studied drugs were injected slowly and within 20 s. The patient’s vital signs, including non-invasive blood pressure, heart rate, and arterial oxygen saturation were evaluated and recorded 1 min before the injection and every 5 min after the injection until the end of the operation. When studied drugs were injected, other anesthetics, including intramuscular relaxants (atracurium 0.5 mg/kg) and opioids (fentanyl or sufentanil 0.2 mg/kg) were injected intravenously and the patient was anesthetized and underwent intratracheal intubation.
Instruments and data analysis
Data collection was carried out using demographic characteristics questionnaire and NRS. Background characteristics included age, sex, marital status, type of surgery, heart rate, arterial blood pressure, and arterial oxygen saturation were recorded in the anesthesia sheet before and after injection of the studied drugs. To measure the pain intensity, NRS was used, which is a self-report questionnaire and the pain intensity ranges between 0 (no pain) and 10 (the worst pain). This scale includes a straight line with the number 0 written at one end and the number 10 written at the other end, and the above line is divided into 11 equal parts using these numbers. They were asked to indicate their pain intensity by choosing a number between 0 and 10. The validity, reliability, and sensitivity of this instrument to therapeutic effects are confirmed.[18] In this scale, numbers smaller than 1, 2–4, 5–7, and 8–10 indicate no pain, mild, moderate, and severe pain, respectively.[19] The collected data entered SPSS ver. 24 and data analysis was carried out using descriptive as well as analytical tests such as Chi-square, analysis of covariance (ANCOVA), and Bonferroni post hoc test.
Results
The aim of the present study was to compare the intensity of pain caused by intravenous injection of sodium thiopental, propofol, diazepam, and etomidate during the induction of general anesthesia among 200 patients.
The mean and standard deviation (SD) of the participants was 40.46 ± 13.14 years. ANCOVA showed no significant difference between different treatment groups in terms of age (P > 0.05). Other demographic characteristics of patients are given in Table 1.
Table 1.
Demographic characteristics of research participants by study groups
| Variant | Groups | Chi-square | P | |||
|---|---|---|---|---|---|---|
|
| ||||||
| Diazepam number (Percentage) | Thiopental number (Percentage) | Propofol number (Percentage) | Etomidate number (Percentage) | |||
| Gender | ||||||
| Female | 21 (42%) | 24 (48%) | 28 (56%) | 24 (48%) | 1.98 | 0.58 |
| Male | 26 (58%) | 26 (52%) | 22 (44%) | 26 (52%) | ||
| Marital status | ||||||
| Married | 28 (56%) | 32 (64%) | 25 (50%) | 30 (60%) | 5.00 | 0.54 |
| Single | 17 (34%) | 15 (30%) | 16 (32%) | 16 (32%) | ||
| Widow | 5 (10%) | 3 (6%) | 9 (18%) | 4 (8%) | ||
| Education | ||||||
| Under high school | 9 (18%) | 9 (18%) | 14 (28%) | 11 (22%) | 3.67 | 0.72 |
| High school | 25 (50%) | 20 (40%) | 19 (38%) | 19 (38%) | ||
| University | 16 (32%) | 21 (42%) | 17 (34%) | 20 (40%) | ||
As the above table shows, there was no significant difference between the participants in the study groups in terms of sex, marital status, and literacy levels (P > 0.05).
To determine the difference between the mean pain scores between the studied groups, the Bonferroni post hoc test was used and the results showed that the mean pain intensity in the diazepam group was significantly higher from other groups (P = 0.001). There was also a significant difference between the thiopental group with other groups (P = 0.001). The present study showed no significant difference between propofol etomidate groups in terms of pain variables (P > 0.05).
With regard to heart rate and blood pressure 1 min before drug injection, results showed that only the heart rate variable affected the pain intensity at this period. To evaluate the mean pain intensity among the studied groups, the ANCOVA test was used, which after controlling the heart rate variable, the results are given in Tables 2 and 3.
Table 2.
Mean and standard deviation of pain in the studied groups
| Group | n | Mean | Std. deviation |
|---|---|---|---|
| Diazepam | 50 | 8.42 | 1.49 |
| Thiopental | 50 | 6.92 | 2.81 |
| Propofol | 50 | 3.30 | 1.84 |
| Etomidate | 50 | 3.26 | 1.79 |
Table 3.
Comparison of pain intensities in the study groups using the ANCOVA test
| Source | Type III sum of squares | df | Mean square | F | Sig. |
|---|---|---|---|---|---|
| H.R 1 min before injection | 21.86 | 1 | 21.861 | 5.32 | 0.02 |
| Group | 1039.21 | 3 | 346.40 | 84.42 | 0.001 |
| Error | 800.11 | 195 | 4.10 |
R2=0.566 (Adjusted R2=0.557)
As Table 3 shows, there was a significant difference between the study groups in terms of mean pain score (F = 84.42, df = 3, P = 0.001).
Figure 2 shows the mean heart rate and MAP index 1 min before and 5 min after injection by study groups.
Figure 2.
Mean heart rate and MAP index 1 min before and 5 min after injection by study groups
Discussion
The aim of the present study was to evaluate the pain intensity due to the intravenous injection of diazepam, sodium thiopental, propofol, and etomidate, which are said to be responsible for the highest pain intensity, respectively. An important and common characteristic of all four aforementioned drugs is injection pain, which can be an effective factor in expressing patients’ experience of their surgery.
In this study, the intensity of injection pain was significantly higher in the sodium thiopental group than in the propofol group, which is not consistent with the results of the study by Zhou et al.[22] This discrepancy may be due to the relationship between stress and anxiety, type, and extent of surgery. However, the incidence of pain was expressed by patients in both studies. The injection pain of diazepam is due to the presence of propylene glycol in some of its formulations or diazepam deposition at the injection site.[23] Numerous studies have reported diazepam pain.[2,19,24] Some studies have used various measures have been suggested to reduce the incidence or intensity of pain induced by intravenous diazepam, such as injection in the large vein, local administration of anesthetics, opioids,[25] metoclopramide,[26,27] and diphenhydramine.[28] Mamiya et al.[29] compared the intensity of injection pain of propofol, diazepam, and midazolam. They reported that the propofol significantly increased injection pain in a way that the intensity of injection pain in the propofol group was significantly higher than in the diazepam group, which is inconsistent with the results of the present study. Kaushal et al.,[30] investigated the effect of using etomidate and propofol on the induction of patients with cardiovascular bypass surgery. They divided patients into two groups: etomidate and propofol. They found the highest hemodynamic stability and most favorable results in the etomidate group, which is consistent with the results of the present study. Propofol reduces blood pressure considering its negative isotope and vasodilatory properties.[31] Propofol is a common anesthetic drug, one of the specific side effects of which is injection pain, which has been mentioned in many articles.[12,32,33,34,35,36] Propofol injection induces pain by stimulating the mucosa and the inner wall of the veins.[37] In a study, Miner et al.[38] compared etomidate and propofol for emergency sedation. They found no significant difference between etomidate and propofol in terms of intensity of injection pain and the hemodynamic changes, which confirms the results of the present study. Etomidate is a short-acting anesthetic that causes side effects such as myoclonus, nausea and vomiting, injection site pain, and adrenal axis suppression.[39,40] In a study, Safavi et al.[41] compared the effect of sodium thiopental, magnesium sulfate, and midazolam; etomidate and remifentanil on the incidence of myoclonus and injection of pain etomidate during the induction of anesthesia. They concluded that etomidate has a few cardiovascular complications and causes less hemodynamic changes, which is consistent with the results of the present study.
In a study, Saricaoglu et al.[42] compared the pain intensity of etomidate, propofol, and a combination of both drugs. They reported that the combination of etomidate and propofol resulted in greater hemodynamic stability during the induction of anesthesia. There was also no injection pain in this group, whereas the incidence of injection pain in the other two groups was almost equally high, which is consistent with the results of the present study.
In a study, Limin et al.[43] investigated the effect of two drugs etomidate and propofol in endoscopic candidate patients and concluded that there was no significant difference between propofol recipients and etomidate recipients in terms of the hemodynamic changes, which is consistent with the results of the present study. In this study, the injection pain was significantly higher in the sodium thiopental group than in the propofol group. Choi et al.[44] also compared the cardiopulmonary effects of sodium thiopental and propofol. They found that propofol causes fewer hemodynamic changes as compared to sodium thiopental, including a decrease in systolic blood pressure. The above study regarded propofol as a more appropriate drug than sodium thiopental and recommended its use, which is consistent with the results of the present study.
Limitations
One of the limitations of the present study was the lack of etomidate, which was solved with the help of hospital staff and other anesthesiologists.
Conclusion
The present study revealed that the use of diazepam and sodium thiopental as anesthetic drugs was associated with more intense injection pain and less hemodynamic stability. The results of the present study indicated that propofol and etomidate are preferable over diazepam and sodium thiopental in abdominal and gastrointestinal surgeries considering their less pain intensity and less hemodynamic changes.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
Acknowledgments
The authors would like to express their gratitude to all patients and their companions, as well as the operating room staff and the Vice Chancellor for Research of Yasouj University of Medical Sciences.
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