Intranasal ketamine for procedural sedation in children: An open-label multicenter clinical trial.

Abstract

INTRODUCTION:

There are limited options for pain and distress management in children undergoing minor procedures, without the burden of an intravenous line insertion. Prior to this study, we conducted a dose-escalation study and identified 6 mg/kg as a potentially optimal initial dose of intranasal ketamine.

OBJECTIVE:

To assess the efficacy and safety of intranasal ketamine at a dose of 6 mg/kg for procedural sedation to repair lacerations with sutures in children in the emergency department.

METHODS:

We conducted a single-arm, open-label multicenter clinical trial for intranasal ketamine for laceration repair with sutures in children aged 1 to 12 years. A convenience sample of 30 patients received 6 mg/kg of intranasal ketamine for their procedural sedation. The primary outcome was the proportion (95% CI) of patients who achieved an effective procedural sedation.

RESULTS:

We recruited 30 patients from April 2018 to December 2019 in two pediatric emergency departments in Canada. Lacerations repaired were mostly facial in 21(70%) patients and longer than 2 cm in 20 (67%) patients. Sedation was effective in 18/30 (60% [95% CI 45, 80]) children and was suboptimal in 5 (17%) patients but procedure was completed in them with minimal difficulties. Sedation was poor in the remaining 7 (23%) patients, with 3 (10%) of them required additional sedative agents. No serious adverse events were reported.

CONCLUSIONS:

Using a single dose of 6 mg/kg of intranasal Ketamine for laceration repair led to successful sedation in 60% of patients according to our a priori definition. An additional 17% of patients were considered suboptimal, but their procedure was still completed with minimal difficulty.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov (NCT03053947).

• Authors: Soha Rached-d'Astous, Yaron Finkelstein, Benoit Bailey, Christopher Marquis, Denis Lebel, Marie-Pier Desjardins, Evelyne D Trottier
• Journal: The American journal of emergency medicine (Am J Emerg Med) Vol. 67 Pg. 10-16 (05 2023) ISSN: 1532-8171 [Electronic] United States
• PMID: 36774905 (Publication Type: Multicenter Study, Journal Article)
• Copyright: Copyright © 2023. Published by Elsevier Inc.

Chemical References

• Ketamine
• Analgesics
• Hypnotics and Sedatives

Topics

• Child
• Humans
• Ketamine (adverse effects)
• Lacerations (surgery)
• Administration, Intranasal
• Analgesics
• Hypnotics and Sedatives
• Emergency Service, Hospital
• Conscious Sedation (methods)