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

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

doi:10.1016/j.annemergmed.2023.01.023

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

Ann Emerg Med. 2023 Aug;82(2):179-190. doi: 10.1016/j.annemergmed.2023.01.023. Epub 2023 Mar 3.

Authors

Affiliations

¹ Department of Pediatrics, Internal Medicine, Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. Electronic address: poonai@hotmail.com.
² Department of Pediatrics, BC Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
³ Department of Pediatrics, University of Alberta, Women and Children's Research Institute, Edmonton, Alberta, Canada.
⁴ Department of Pediatrics, Internal Medicine, Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
⁵ Department of Pediatrics, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.
⁶ Department of Pediatrics, CHU Ste Justine, Université de Montréal, Montreal, Quebec, Canada.
⁷ University of Toronto.

PMID: 36870890
DOI: 10.1016/j.annemergmed.2023.01.023

Abstract

Study objective: To determine the optimal sedative dose of intranasal dexmedetomidine for children undergoing laceration repair.

Methods: This dose-ranging study employing the Bayesian Continual Reassessment Method enrolled children aged 0 to 10 years with a single laceration (<5 cm), requiring single-layer closure, who received topical anesthetic. Children were administered 1, 2, 3, or 4 mcg/kg intranasal dexmedetomidine. The primary outcome was the proportion with adequate sedation (Pediatric Sedation State Scale score of 2 or 3 for ≥90% of the time from sterile preparation to tying of the last suture). Secondary outcomes included the Observational Scale of Behavior Distress-Revised (range: 0 [no distress] to 23.5 [maximal distress]), postprocedure length of stay, and adverse events.

Results: We enrolled 55 children (35/55 [64%] males; median [interquartile range {IQR}] age 4 [2, 6] years). At 1, 2, 3, and 4 mcg/kg intranasal dexmedetomidine, respectively, the proportion of participants "adequately" sedated was 1/3 (33%), 2/9 (22%), 13/21 (62%), and 12/21 (57%); the posterior mean (95% equitailed credible intervals) for the probability of adequate sedation was 0.38 (0.04, 0.82), 0.25 (0.05, 0.54), 0.61 (0.41, 0.80), and 0.57 (0.36, 0.76); the median (IQR) Observational Scale of Behavior Distress-Revised scores during suturing was 2.7 (0.3, 3), 0 (0, 3.8), 0.6 (0, 5), and 0 (0, 3.7); the median (IQR) postprocedure length of stay was 67 (60, 78), 76 (60, 100), 89 (76, 109), and 113 (76, 150) minutes. There was 1 adverse event, a decrease in oxygen saturation at 4 mcg/kg, which resolved with head repositioning.

Conclusion: Despite limitations, such as our limited sample size and subjectivity in Pediatric Sedation State Scale scoring, sedation efficacy for 3 and 4 mcg/kg were similarly based on equitailed credible intervals suggesting either could be considered optimal.

Trial registration: ClinicalTrials.gov NCT03957304.

Publication types

Clinical Trial, Phase II
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Intranasal
Bayes Theorem
Child
Dexmedetomidine* / adverse effects
Female
Humans
Hypnotics and Sedatives
Lacerations* / surgery
Male

Substances

Dexmedetomidine
Hypnotics and Sedatives

Associated data

ClinicalTrials.gov/NCT03957304