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Intranasal ketamine for procedural sedation in children: An open-label multicenter clinical trial
Soha Rached-d'Astous1, Yaron Finkelstein2, Benoit Bailey1
1Pediatric Emergency Department, Centre Hospitalier Universitaire Sainte Justine, Université de Montréal, 3175 Chem. de la Cote-Sainte-Catherine, Montreal, Quebec H3T 1C5, Canada.
Insights
Intranasal ketamine at 6 mg/kg effectively sedated 60% of children for laceration repair, offering a needle-free option for procedural pain management. This study highlights its potential as a safe and viable alternative for pediatric emergency care.
Area of Science:
- Pediatric Emergency Medicine
- Pain Management
- Pharmacology
Background:
- Effective procedural sedation in children for minor injuries like lacerations is challenging without IV access.
- Intranasal ketamine offers a needle-free alternative for pediatric procedural sedation.
- A prior dose-escalation study identified 6 mg/kg as a potentially optimal dose.
Purpose of the Study:
- To evaluate the efficacy and safety of 6 mg/kg intranasal ketamine for sedating children undergoing laceration repair with sutures.
- To determine the success rate of procedural sedation using this non-intravenous method.
Main Methods:
- A single-arm, open-label, multicenter clinical trial was conducted.
- 30 children aged 1-12 years received 6 mg/kg intranasal ketamine for laceration repair.
- The primary outcome measured was the proportion of patients achieving effective procedural sedation.
Main Results:
- Sedation was effective in 60% (18/30) of children.
- An additional 17% (5/30) experienced suboptimal sedation but completed the procedure with minimal difficulty.
- No serious adverse events were reported during the study.
Conclusions:
- A single 6 mg/kg dose of intranasal ketamine achieved successful procedural sedation in 60% of pediatric patients undergoing laceration repair.
- The treatment was generally safe and facilitated procedure completion, even in cases of suboptimal sedation.
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).
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