Optimal Dose of Intranasal Dexmedetomidine for Laceration Repair in Children: A Phase II Dose-Ranging Study

Poonai, Naveen; Sabhaney, Vikram; Ali, Samina; Stevens, Holly; Bhatt, Maala; Trottier, Evelyne D; Brahmbhatt, Shaily; Coriolano, Kamary; Chapman, Amanda; Evans, Natalie; Mace, Charlotte; Creene, Christopher; Meulendyks, Sarah; Heath, Anna

doi:10.1016/j.annemergmed.2023.01.023

Cited by 5 publications

(4 citation statements)

References 59 publications

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“…Study designs included 11 RCTs, 22,[32][33][34][35][36][37][38][39][40][41] 13 cohort studies and other nonrandomized studies, [19][20][21]23,[42][43][44][45][46][47][48][49][50] and 11 case series and case reports. 12,[51][52][53][54][55][56][57][58][59][60] Six of the included studies were conference abstracts.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…52,53 However, DEX was inferior to midazolam plus fentanyl in another trial, 36 was not associated with a more rapid time to discharge than ketamine or midazolam in retrospective matched-cohort study, 47 and was associated with only 60% sedation success in a prospective dose-ranging study. 50 Most studies reported no patient-level or drug-level efficacy results.…”

Section: Procedural Sedationmentioning

confidence: 99%

“…12,[51][52][53][54][55][56][57][58][59][60] Six of the included studies were conference abstracts. 20,21,40,47,50,56 Dates of publication ranged from 2010 to Each of the 11 case reports and case series were judged to be either high risk of bias or had some concerns. Indications for DEX varied as reported in Table 4; the indication was procedural sedation in two studies, and several studies reported the use of DEX for agitation due to general medical conditions such as asthma exacerbation, baclofen withdrawal, sepsis, and familial dysautonomia.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…The most common indication for DEX was procedural sedation, which was reported in three RCTs, 32,36,39 six cohort and nonrandomized studies, 19,20,43,47,48,50 and two case reports or series. 52,53 Pooling of efficacy results was not feasible due to the heterogeneity of DEX dose and route, procedures being reported, and outcome measurements used.…”

Section: Procedural Sedationmentioning

confidence: 99%

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The use of dexmedetomidine in the emergency department: A systematic review

Baumgartner

Groff

Yaeger

et al. 2022

Academic Emergency Medicine

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Sedatives, anxiolytics, and analgesics are near-ubiquitous interventions during daily care in the emergency department (ED). The agents most commonly used to treat intubated patients include sedatives acting on the gamma-aminobutyric acid (GABA) receptor, such as benzodiazepines and propofol, as well as the opioid analgesic fentanyl. Benzodiazepines are highly deliriogenic 1 and may prolong duration of mechanical ventilation and length of stay. 2 Propofol can be associated with significant hypotension and with a life-threatening

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Section: Study Characteristicsmentioning

confidence: 99%

Section: Procedural Sedationmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Section: Procedural Sedationmentioning

confidence: 99%

See 2 more Smart Citations

The use of dexmedetomidine in the emergency department: A systematic review

Baumgartner

Groff

Yaeger

et al. 2022

Academic Emergency Medicine

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Intranasal Dexmedetomidine: Should It Have a Place in Your Emergency Department?

Tsze¹

2023

Annals of Emergency Medicine

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A comparison of alternative ranking methods in two-stage clinical trials with multiple interventions: An application to the anxiolysis for laceration repair in children trial

Tran,

McGrory,

Poonai

et al. 2024

Clinical Trials

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Background/Aims: Multi-arm, multi-stage trials frequently include a standard care to which all interventions are compared. This may increase costs and hinders comparisons among the experimental arms. Furthermore, the standard care may not be evident, particularly when there is a large variation in standard practice. Thus, we aimed to develop an adaptive clinical trial that drops ineffective interventions following an interim analysis before selecting the best intervention at the final stage without requiring a standard care. Methods: We used Bayesian methods to develop a multi-arm, two-stage adaptive trial and evaluated two different methods for ranking interventions, the probability that each intervention was optimal (P best) and using the surface under the cumulative ranking curve (SUCRA), at both the interim and final analysis. The proposed trial design determines the maximum sample size for each intervention using the Average Length Criteria. The interim analysis takes place at approximately half the pre-specified maximum sample size and aims to drop interventions for futility if either P best or the SUCRA is below a pre-specified threshold. The final analysis compares all remaining interventions at the maximum sample size to conclude superiority based on either P best or the SUCRA. The two ranking methods were compared across 12 scenarios that vary the number of interventions and the assumed differences between the interventions. The thresholds for futility and superiority were chosen to control type 1 error, and then the predictive power and expected sample size were evaluated across scenarios. A trial comparing three interventions that aim to reduce anxiety for children undergoing a laceration repair in the emergency department was then designed, known as the Anxiolysis for Laceration Repair in Children Trial (ALICE) trial. Results: As the number of interventions increases, the SUCRA results in a higher predictive power compared with P best. Using P best results in a lower expected sample size when there is an effective intervention. Using the Average Length Criterion, the ALICE trial has a maximum sample size for each arm of 100 patients. This sample size results in a 86% and 85% predictive power using P best and the SUCRA, respectively. Thus, we chose P best as the ranking method for the ALICE trial. Conclusion: Bayesian ranking methods can be used in multi-arm, multi-stage trials with no clear control intervention. When more interventions are included, the SUCRA results in a higher power than P best. Future work should consider whether other ranking methods may also be relevant for clinical trial design.

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Optimal Dose of Intranasal Dexmedetomidine for Laceration Repair in Children: A Phase II Dose-Ranging Study

Cited by 5 publications

References 59 publications

The use of dexmedetomidine in the emergency department: A systematic review

The use of dexmedetomidine in the emergency department: A systematic review

Intranasal Dexmedetomidine: Should It Have a Place in Your Emergency Department?

A comparison of alternative ranking methods in two-stage clinical trials with multiple interventions: An application to the anxiolysis for laceration repair in children trial

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