NCT03053947

Pain Free Laceration Repairs Using Intra-nasal Ketamine

Completed Phase 2 Last updated 16 December 2019

What this trial tests

Phase 2 trial testing Intranasal Ketamine in Laceration in 42 participants. Completed in 27 November 2019.

Timeline

16 February 2017

Primary endpoint
27 November 2019

27 November 2019

Quick facts

Lead sponsor	Evelyne D.Trottier
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	16 February 2017
Primary completion	27 November 2019
Estimated completion	27 November 2019
Sites	2 locations across Canada

Drugs / interventions tested

• Intranasal Ketamine — full drug profile →

Conditions studied

• Laceration — all drugs for Laceration →

Sponsor

Evelyne D.Trottier

Who can join

Adults 1 to 12, any sex, with Laceration. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Lacerations are one of most common trauma in children presenting to the emergency department (ED). Currently, there are wide variations regarding sedation and analgesia practices when suture are required. Even though topical anesthesia is very useful to reduce pain, it does not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing laceration repairs in the ED.

There is a growing interest in the intranasal (IN) route of administration in the pediatric population. It bypasses the first hepatic passage and thus provides medications direct access to the systemic circulation leading to higher and faster serum concentrations than would the oral route. Also, intravenous (IV) cannulation can be avoided reducing the pain associated with it and the need for nursing time and procedure delay. IN fentanyl and midazolam are two agents that can be combined for this procedure, but respiratory depression is a feared adverse effects. Ketamine is the most commonly used IV agent for procedural sedation, and can offer potent analgesia and sedation while maintaining respiratory drive and protective airway reflexes. Few studies have evaluated IN ketamine for procedural sedation. There is a wide range of dosing reported from 3 to 9 mg/kg. This raises the question as what is the lowest possible dosage that can be used to successfully repairs laceration in children with minimal restrain and no adverse events, as described by the Pediatric Emergency Research Canada (PERC)/ Pediatric Emergency Care Applied Research Network (PECARN) consensus.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Intranasal ketamine for procedural sedation in children: An open-label multicenter clinical trial.
   Rached-d'Astous S, Finkelstein Y, Bailey B, Marquis C, et al · · 2023 · cited 5× · PMID 36774905 · DOI 10.1016/j.ajem.2023.01.046