Abstract
Introduction
Pro re nata (PRN) medications can be administered for the treatment of agitation. Evidence-based recommendations for the pharmacologic treatment of agitation in children and adolescents admitted to a behavioral health unit are limited. The primary objective of this study was to analyze medication use patterns for managing agitation in a pediatric and adolescent inpatient behavioral health unit. The secondary objective was to evaluate the effectiveness and safety of commonly administered PRN medications in this population.
Methods
This retrospective chart review included patients who received a 1-time or PRN medication for agitation while admitted to a pediatric and adolescent behavioral health unit between July 1, 2020, and June 31, 2022. Primary outcomes examined agents administered and the route and rate of concurrent medication administration. Secondary outcomes included administration of subsequent medications, the use of restraint or seclusion as a surrogate marker for effectiveness, and rate of adverse events for safety.
Results
A total of 191 patients were included in the final analysis. There were 1238 doses of 1-time or PRN medication administered for agitation during the study period. Antipsychotics were administered most frequently (661, 53.4%). However, the most commonly administered medications were diphenhydramine (327, 26.4%), lorazepam (235, 19%), and olanzapine (224, 18.1%). Antipsychotic-induced extrapyramidal symptoms (EPS) occurred in 3 instances (0.24%), with all being managed with diphenhydramine.
Discussion
When treating agitation in pediatric and adolescent patients admitted to an inpatient behavioral health unit, antipsychotics were administered most frequently. It appears that most doses were well tolerated, except for EPS in a subset of patients.
Keywords: pediatric, adolescent, agitation, inpatient, behavioral health
Introduction
Agitation is a challenging behavioral health concern that is seen in emergency departments (EDs) and inpatient behavioral health units. Acute agitation episodes can pose a significant safety risk (eg, danger to self and/or others nearby).1 In the APPLIED study, Manuel and colleagues2 observed the prevalence of agitation among all behavioral health patients presenting to a pediatric ED to be 13.8%. This study concluded that effective non-pharmacological de-escalation strategies may reduce the need for physical restraint or seclusion.2 The Best Practices for Evaluation and Treatment of Agitated (BETA) Children and Adolescents guidelines, the British Columbia treatment of Agitation with Least Medication Restraint (B CALMER) working group, and the American Psychiatric Association all recommend using less restrictive means (eg, non-pharmacologic strategies and pharmacologic management) before considering physical restraints and/or seclusion.1,3,4 Unfortunately, extensive evidence-based recommendations for the pharmacologic management of agitation in pediatric and adolescent patients presenting to an inpatient behavioral health unit are limited.
Both the BETA guidelines and B CALMER clinical pathway provide pharmacotherapy recommendations for specific etiologies on the use of antipsychotics (APs) and benzodiazepines (BZDs), including the management of delirium and mania or psychosis.1,3 Most additional agitation research for pediatric and adolescent patients is based in the ED setting. Kendrick and colleagues5 conducted a retrospective study examining the use of APs and BZDs for acute agitation and aggression in pediatric patients in the ED. They concluded that APs and BZDs are generally safe and well-tolerated as single-use agents for managing agitation in pediatric patients.5
The APPLIED study is a retrospective observational study focused on the prevalence and predictors of acute agitation among all behavioral health patients presenting to a pediatric ED. Among all doses administered in the APPLIED study, the most frequently used agents included olanzapine (51%), lorazepam (40.1%), ziprasidone (31.6%), risperidone (18.3%), and haloperidol (10.5%), with approximately 35% of patients receiving concurrent medications. Common concurrent regimens included a BZD with an AP. Diphenhydramine was rarely administered as monotherapy (2.8%) for the management of agitation in their cohort. The investigators also noted that, compared with other patients, the admission rate for patients experiencing agitation was higher, especially among those who required restraint.2
For pediatric patients presenting with agitation, there are likely to be similarities in pharmacotherapy management between those presenting to the ED versus an inpatient behavioral unit. An additional gap in the literature is dosing guidance for pharmacotherapy management. Yip and colleagues6 aimed to determine the optimal dose of various pro re nata (PRN) medications for agitation in pediatric patients and determined the following mean effective doses: quetiapine 32 mg/dose, haloperidol 4 mg/dose, loxapine 13 mg/dose, and chlorpromazine 29 mg/dose. They also observed that concomitant lorazepam was administered to 6 (18.8%) patients on quetiapine, 10 (90.9%) on haloperidol, 8 (80%) on loxapine, and 4 (25%) on chlorpromazine.6 Overall, a better understanding of current prescribing practices in an inpatient behavioral health unit is vital in determining more effective and safer practices for pharmacologic management of agitation in this specific patient population. The primary objective of this study was to describe medication use patterns in a pediatric and adolescent inpatient behavioral health unit. The secondary objective was to evaluate the effectiveness and safety of commonly administered medications for the management of agitation in our institution.
Methods
Design and Participants
A retrospective chart review was completed for patients admitted to a pediatric and adolescent inpatient behavioral health unit within a large academic medical center between July 1, 2020, and June 31, 2022. Data were retrieved from the electronic health record (EHR) via a combination of internal reporting software and manual chart review. This study was determined to be a quality improvement by the institutional review board (IRB), thereby exempting it from requiring IRB approval. All instances of patients aged 6 to 18 years at the time of the encounter who received a PRN or an order for a medication used to manage agitation during the encounter were included. This age range was selected because it aligns with the admission criteria for the institution's inpatient pediatric and adolescent behavioral health unit. Patients were excluded if they were pregnant during the encounter or only treated with a PRN medication for indications other than agitation, based on manual chart review.
Data Collection
Baseline demographic characteristics collected included patient sex, age, race, and the diagnostic-related group (DRG) for the encounter. Patient charts were reviewed to confirm DRGs; thus, patients with multiple DRGs were included in the final data set. Medication use patterns were determined by reviewing the agent(s) administered, the number of doses, the strength, route, concurrent medication(s), and documented indications. Concurrent medications were defined as more than 1 agent administered within 5 minutes of one another. Doses administered between 5 and 120 minutes after the first agent were defined as subsequent doses. These definitions were selected in collaboration with nursing staff on the inpatient pediatric and adolescent behavioral health unit based on usual practice. Nursing staff described that medications administered with the intent of concomitant use would almost always be documented within 5 minutes of each other. Subsequent medications are requested and administered if an inadequate response was obtained before the next available administration time. At this institution, PRN administration availability times is standardized to 120 to 360 minutes. Nursing and physician staff described an inadequate response to initial medications, largely subjectively, and did not perform standardized assessments or rating scales. Therefore, the need for subsequent doses and for orders of restraint or seclusion was selected as a surrogate marker of the effectiveness of the initial regimen. Orders for subsequent restraint or seclusion were defined as active orders within 31 to 120 minutes of the most recent agitation medication administered, based on the institutional practice.
Safety was determined by the presence of adverse drug reactions (ADRs) documented in the EHR. The ADRs assessed were the development of extrapyramidal symptoms (EPS) and vital sign derangements that could indicate the development of orthostasis or neuroleptic malignant syndrome. Medication administration record (MAR) comments were reviewed to assess the use of diphenhydramine as a preventative agent versus a treatment for the development of EPS. If a MAR comment indicated that the administration was for the treatment of EPS, these administrations were captured in the safety analysis rather than the effectiveness analysis. Vital signs included heart rate, blood pressure, and temperature. These were evaluated against standard ranges proposed by the United States Department of Health and Human Services and the American Academy of Pediatrics.7-9
Statistical Analysis
Data were abstracted from the EHR and entered into REDCap. Descriptive statistics were used to summarize demographic characteristics and general medication use patterns. Statistical comparisons for categorical data were made between groups using Χ2 or Fisher’s exact tests. Continuous data were compared between groups using Mann-Whitney U tests. SPSS version 28 was used for statistical analysis.10 P values < 0.05 were considered statistically significant.
Results
A total of 191 unique patients with 219 hospital encounters were evaluated during the 2-year period. There were 958 medication regimens, totaling 1238 individual medication administrations, most of which were administered orally (n = 997, 80.5%) compared with intramuscularly (IM) (n = 241, 19.5%). The following medication classes were used: APs (53.4%), anticholinergic agents (26.4%), BZDs (19.4%), and alpha-2 agonists (0.8%). Of note, diphenhydramine was the only anticholinergic agent administered while clonidine was the only alpha-2 agonist administered. Most patients were Caucasian (n = 114, 52.1%), male (n = 125, 57.1%), and had DRGs of depressive and anxiety disorders (n = 132, 60.3%) and/or neurodevelopmental disorders (n = 126, 57.5%). Baseline demographic characteristics are further described in Table 1.
Table 1.
Demographic characteristics of patient encounters (N = 219)
| Sex, n (%) | |
| Male | 125 (57.1) |
| Female | 94 (42.9) |
| Age, yr (median, IQR 1, 3) | 15 (12, 16) |
| Race, n (%) | |
| Caucasian | 114 (52.1) |
| African American | 79 (36.1) |
| Other* | 26 (11.9) |
| Hospital length of stay, days (median, IQR 1, 3) | 12 (8,17.7) |
| Diagnosis-related group†, n (%) | |
| Depressive and anxiety disorders | 132 (60.3) |
| Neurodevelopmental disorders | 126 (57.5) |
| Disruptive, impulse-control, and conduct disorders | 76 (34.7) |
| Schizophrenia spectrum and other psychotic disorders | 61 (27.9) |
| Trauma- and stressor-related disorders | 59 (26.9) |
| Bipolar and related disorders | 33 (15.1) |
| Substance-related and addictive disorders | 33 (15.1) |
IQR = interquartile range.
Other = includes Asian, others, patient refused.
Patients may have had multiple diagnostic-related groups in a single encounter.
Of all 1238 administrations, second-generation APs (SGAs) were administered most often (419, 33.8%), followed by anticholinergic agents (327, 26.4%). First-generation APs (FGAs) and BZDs had similar rates of use (242, 19.5%; 240, 19.4%, respectively). Among specific agents, diphenhydramine (n = 327, 26.4%), lorazepam (n = 235, 19%), and olanzapine (n = 224, 18.1%) were most frequently administered. Medications were more commonly administered as single agents (n = 731, 76.3%) than in concurrent regimens (n = 227, 23.7%). Of the single-agent regimens, olanzapine (n = 174, 23.8%), lorazepam (n = 146, 20%), and diphenhydramine (n = 115, 15.7%) remained the most frequently used agents. For concurrent regimens, the most common combination was diphenhydramine plus an AP (n = 136, 60.2%), followed by a 3-agent regimen of AP, diphenhydramine, and BZD (n = 53, 23.5%). Of the 2-agent combinations, haloperidol plus diphenhydramine (58/136, 42.6%) was most commonly administered concurrently. Of the 3-agent combinations, chlorpromazine plus diphenhydramine plus lorazepam (29/53, 54.7%) was most commonly administered concurrently. Table 2 includes additional administration data, including median doses administered. Of the most commonly administered agents in this study, the median dose administered was diphenhydramine 25 mg oral and IM, lorazepam 1 mg oral and 2 mg IM, and olanzapine 2.5 mg oral and IM.
Table 2.
Medication-use patterns
| Medication | Total Number of Doses, n (%) | Doses via PO Route, n (%) | Median Total Dose, mg (range) |
|---|---|---|---|
| Second-Generation Antipsychotic Agents | |||
| Olanzapine | 224 (18.1) | 165 (73.7) | PO: 2.5 (2.5-5) IM: 2.5 (2.5-10) |
| Risperidone | 108 (8.7) | 108 (100) | PO: 0.5 (0.25-1) |
| Quetiapine | 55 (4.4) | 55 (100) | PO: 25 (12.5-100) |
| Aripiprazole | 32 (2.6) | 32 (100) | PO: 2.5 (2-5) |
| First-Generation Antipsychotic Agents | |||
| Haloperidol | 126 (10.2) | 86 (68.3) | PO: 2.5 (2-5) IM: 2.5 (2.5-5) |
| Chlorpromazine | 116 (9.4) | 101 (87.1) | PO: 25 (12.5-125) IM: 12.5 (12.5-75) |
| Benzodiazepines | |||
| Lorazepam | 235 (19) | 188 (80) | PO: 1 (0.25-2) IM: 2 (0.5-2) |
| Clonazepam | 5 (0.4) | 5 (100) | PO: 0.5 (0.25-2) |
| Alpha-2 Agonist Agents | |||
| Clonidine | 10 (0.8) | 10 (100) | PO: 0.075 (0.05-0.1) |
| Anticholinergic Agents | |||
| Diphenhydramine | 327 (26.4) | 247 (75.5) | PO: 25 (25-50) IM: 25 (12.5-50) |
IM = intramuscular; PO = by mouth.
Medications may have been administered in combination with another medication in the list to assist in managing the acute agitation episode.
Medication use patterns were further analyzed to assess trends based on the patient’s sex and race (Table 3). The rate of concurrent regimen administration was significantly higher in male patients than in females (28.9% vs 15%, respectively, P < 0.001). There was also a statistically significant difference in race when examining the rate of administration of concurrent regimens (Caucasian 27.7% vs African American 20.5% vs Other 12.1%, P < 0.001). There was no difference when comparing IM and oral administrations in relation to the patient sex or race (P = 0.08 and P = 0.32, respectively). Focusing on AP agents administered, there were no differences in FGA or SGA administration based on sex (P = 0.84), but there was a statistically significant difference when examining race (P < 0.001) (Table 3).
Table 3.
Subgroup analyses
| Regimen | |||
|---|---|---|---|
| N = 958 | Single Agent, n (%) | Concurrent, n (%) | P Value |
| Sex | <0.001 | ||
| Male (n = 598) | 425 (71.1) | 173 (28.9) | |
| Female (n = 360) | 306 (85) | 54 (15) | |
| Race | <0.001 | ||
| Caucasian (n = 548) | 396 (72.3) | 152 (27.7) | |
| African American (n = 303) | 241 (79.5) | 62 (20.5) | |
| Other* (n = 107) | 94 (87.9) | 13 (12.1) | |
| Subsequent medication | 0.001 | ||
| No subsequent medications (n = 900) | 677 (92.6) | 223 (98.2) | |
| Required subsequent medications (n = 58) | 54 (7.4) | 4 (1.8) | |
| Restraint/seclusion | 0.089 | ||
| No subsequent restraint/seclusion orders (n = 944) | 723 (98.9) | 221 (97.4) | |
| Subsequent restraint/seclusion orders (n = 14) | 8 (1.1) | 6 (2.6) | |
| Route of Administration | |||
| N = 1238 | Oral, n (%) | IM, n (%) | P Value |
| Sex | 0.08 | ||
| Male (n = 814) | 667 (81.9) | 147 (18.1) | |
| Female (n = 424) | 330 (77.8) | 94 (22.2) | |
| Race | 0.32 | ||
| Caucasian (n = 741) | 598 (80.8) | 143 (19.3) | |
| African American (n = 374) | 306 (81.8) | 68 (18.2) | |
| Other* (n = 123) | 93 (75.6) | 30 (24.4) | |
| Antipsychotic Selection | |||
| N = 661 | FGA, n (%) | SGA, n (%) | P Value |
| Sex | 0.84 | ||
| Male (n = 424) | 154 (63.6) | 270 (64.4) | |
| Female (n = 237) | 88 (36.4) | 149 (35.6) | |
| Race | <0.001 | ||
| Caucasian (n = 389) | 168 (43.2) | 221 (56.8) | |
| African American (n = 187) | 54 (28.9) | 133 (71.1) | |
| Other* (n = 85) | 20 (23.5) | 65 (76.5) | |
FGA = first-generation antipsychotic; IM = intramuscular; SGA = second-generation antipsychotic.
Other = includes Asian, others, patient refused.
Total number of medication regimens administered = 958.
Total of individual medications administrations = 1238.
Total number of antipsychotic agents administered = 661.
When evaluating surrogate markers for effectiveness, there were 58 encounters (26.5%) where patients required subsequent dose(s). Among all medication regimens requiring subsequent medications, the proportion who initially received a single-agent regimen was significantly higher than that of those who initially received concurrent medications (7.4% vs 1.8%; P = 0.001). Most subsequent medications (n = 37, 64%) were administered via the same route as the initial administration (Table 3). The rate of restraint or seclusion orders was low, with 1.5% of all regimens having subsequent orders for restraint or seclusion. Of the events with subsequent orders for restraint/seclusion, there was no significant difference in this rate between single-agent and concurrent regimens (1.1% vs 2.6%, P = 0.089).
The only ADR identified was EPS in relation to 3 (0.24%) medication administrations. In 1 instance, the patient received haloperidol 2 mg by mouth, and in 2 other instances, the patients received risperidone (0.5 mg and 1 mg) by mouth before receiving diphenhydramine to treat EPS. There were 9 (0.73%) instances where patients received diphenhydramine concurrently with an AP to prevent EPS. In 1 instance, the patient received a dose of diphenhydramine prophylactically to prevent EPS concurrently with an AP, after previously requiring diphenhydramine to treat EPS during an AP administration. The AP agents administered concurrently with diphenhydramine for prevention of EPS were risperidone (n = 4, 0.32%), haloperidol (n = 2, 0.16%), olanzapine (n = 2, 0.16%), and chlorpromazine (n = 1, 0.08%). The indication for all other diphenhydramine administrations (315/327, 96.3%) could not be determined. Documented vitals available for review were within normal limits for all patients.
Discussion
For the treatment of agitation, diphenhydramine was the most administered agent, with similarly high rates of use for both lorazepam and olanzapine. This finding aligns with those of Saito and colleagues,11 where diphenhydramine and lorazepam were administered most frequently for managing agitation in pediatric patients. Single-agent regimens were more common than concurrent regimens. Diphenhydramine plus an AP was the most favored concurrent regimen. Although most literature and guidelines support the use of single-agent regimens to prevent unnecessary polypharmacy, the retrospective nature of this study makes it difficult to ascertain if concurrent regimens were used based on perceived severity of agitation, which has been recommended by some authors.1,3 It is also unknown for most cases whether diphenhydramine was administered concurrently to prevent EPS or for concurrent treatment of agitation. Additionally, per Jeffers and colleagues,12 concurrent administration of haloperidol, lorazepam, and diphenhydramine was not shown to be superior to haloperidol and lorazepam combination therapy. In fact, they found that the triple therapy regimen resulted in increased oxygen desaturation, hypotension, physical restraint use, and longer length of stay.12 Of note, although we did appreciate clonidine use in our study, current literature does not support clonidine use specifically for the management of agitation, but for other indications such as treatment of disruptive behavior associated with attention-deficit/hyperactivity disorder.1
When assessing the use of single agent compared with concurrent regimens, there appeared to be no significant differences between sex or race. However, Caucasian patients received FGAs and SGAs at similar rates, whereas SGAs were used more often than FGAs in African American patients and patients of other races. This difference was not seen when evaluating FGA use between sexes. It is hard to draw robust clinical conclusions from this information, given the retrospective nature of the study. Although provider bias may have led to disparities in FGAs, there are many confounding variables that were not assessed, such as diagnosis and previous medications trialed.
The effectiveness of agents is difficult to establish with retrospective studies. In the current study, patients who received single-agent regimens were more likely to receive subsequent medications than those who received initial concurrent regimens. Most subsequent doses used a different agent than the initial agent administered. This does not align with BETA or B CALMER guidelines, as they recommend trialing a second dose of the same medication if the initial dose seemed to be ineffective to avoid potential drug interactions and adverse effects.1,3 The BETA and B CALMER guidelines also provide dosing ranges for their specified medications. Most of the median doses and dosing ranges for the medications administered in this study fall within those designated ranges. Some instances where the doses administered in this study were higher than the ones listed in the guidelines may be explained by 1-time doses that were administered during a dose titration of the patient’s scheduled regimen rather than to manage agitation.1,3
There was a low incidence of restraint or seclusion after the administration of medication(s), with no significant difference in this rate for single-agent or concurrent regimens. As restraint or seclusion orders were input within 31 to 120 minutes of the medication administration(s), the severity of the agitation may have warranted additional interventions. Dorfman and colleagues13 found that 1 in 20 children who underwent a psychiatric evaluation required physical restraints, which is higher than the rate in the studied population. In line with the BETA and B CALMER guidelines, physical restraints should only be considered after less restrictive means (eg, environmental strategies, oral medications) have been attempted without success.1,3
Overall, most medications in our study were well tolerated, with only a small subset of patients experiencing documented EPS. There were 3 patients who received oral diphenhydramine in response to EPS per MAR comments. There were also 9 instances in which patients received combination therapy with an AP and oral diphenhydramine to prevent EPS. These findings align with those of other studies that used diphenhydramine concurrently with an AP to prevent EPS.6 Of note, paradoxical agitation can occur with BZD and diphenhydramine use.2,3 However, because of the nature of this study, the potential incidence of medication-induced paradoxical agitation may have been underrepresented. Within our cohort, we did not find any significant abnormalities in documented vital signs; however, the majority of the vital signs documented were collected on a scheduled basis, rather than as a 1-time order in relation to medication administration. This may underrepresent the potential impact of the medications on vital signs due to the difficulty in retrospectively ascertaining ADRs resulting from specific medications administered.
It is important to acknowledge several limitations largely due to the retrospective and single-center nature of the study. Notable limitations include the potential impact of formulary access to agents, potentially limiting medication selection. Another limitation is the lack of a standard protocol for objectively measuring agitation before medication administration and documenting both response and tolerability following administration. This required the use of surrogate markers to assess medication response and manual review of ADR documentation. On that note, owing to inconsistent documentation, it was unclear whether diphenhydramine was used to manage agitation or to prevent EPS in most cases; therefore, it was included in both effectiveness and safety analyses. As the authors collaborated with nursing staff to define surrogate markers that do not mirror those defined in literature,3 the results may not be easily generalizable to other institutions. It is also possible that ADRs are underreported in the current study due to inconsistencies in documentation. These gaps in clinical care and documentation may be used to justify psychotropic stewardship services at the institution studied.
Conclusions
For the management of agitation in pediatric and adolescent patients admitted to an inpatient behavioral health unit, antipsychotics were administered most frequently, followed by anticholinergic agents. Most medications also appeared to be well tolerated. Both single-agent and concurrent regimens appear to be viable in managing agitation in this patient population. Given the small patient pool in this study, those who received concurrent regimens were less likely to receive subsequent medications for the management of agitation. Further research, such as multicenter prospective studies, studies focusing on optimal dosing for pediatric patients presenting with agitation, and the relationship between pharmacologic requirements for agitation management and hospital length of stay, would be helpful to determine the overall effectiveness and safety of medications used for the management of agitation in this population.
Acknowledgments
The authors would like to thank Erin Weeda, PharmD, and Amy Hebbard, PharmD, BCPP.
References
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