Optimal Dose of Intranasal Dexmedetomidine for Laceration Repair in Children: A Phase II Dose-Ranging Study - 19/07/23
, Vikram Sabhaney, MD b, Samina Ali, MD c, Holly Stevens, BSc a, Maala Bhatt, MD d, Evelyne D. Trottier, MD e, Shaily Brahmbhatt, BSc a, Kamary Coriolano, PhD a, Amanda Chapman, BSc a, Natalie Evans, BSc a, Charlotte Mace, MD a, Christopher Creene, MD a, Sarah Meulendyks, BScN a, Anna Heath, PhD fAbstract |
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.
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| Please see page 180 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Steven M. Green, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
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| Author contributions: NP and AH conceived the study, designed the trial, and obtained research funding. NP supervised the conduct of the trial and data collection. KC supervised the conduct of the trial and data collection. SB, CM, CC, and SM undertook the recruitment of patients and managed the data, including quality control. HS, AC, and NE viewed and analyzed the video recordings. HS and AH provided statistical advice on study design and analyzed the data. NP, VS, SA, and MB drafted the manuscript. All authors contributed substantially to its revision. NP takes responsibility for the paper as a whole. |
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| All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. Funded by Children's Health Research Institute and Lawson Health Research Institute, London, Ontario, Canada. |
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| Trial registration number: NCT03957304 |
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| A podcast for this article is available at www.annemergmed.com. |
Vol 82 - N° 2
P. 179-190 - août 2023 Retour au numéro
Article précédent
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- Intranasal Dexmedetomidine: Should It Have a Place in Your Emergency Department?
- Daniel S. Tsze
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