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NCT03957304

Intranasal Dexmedetomidine Dose-finding Study

Completed Phase 2 Last updated 7 April 2022
What this trial tests

Phase 2 trial testing Dexmedetomidine in Laceration Repair in 55 participants. Completed in 30 March 2022.

Timeline
20 February 2020
Primary endpoint
30 March 2022
30 March 2022

Quick facts

Lead sponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingquadruple
Primary purposetreatment
Enrollment55
Start date20 February 2020
Primary completion30 March 2022
Estimated completion30 March 2022
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Who can join

Adults 1 to 10, any sex, with Laceration Repair. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The most common injury prompting an emergency department (ED) visit in children is a cut (laceration) that requires repair using stitches or skin glue. Despite anesthetic (freezing), laceration repair is often very distressful because in young children, most occur on the face. There is currently no effective drug to relieve the distress of laceration repair in children. The goal is to find a safe and effective drug to reduce distress in children undergoing laceration repair. Dexmedetomidine is a new drug that safely provides mild sedation and can be given as a painless nasal spray. Intranasal dexmedetomidine (IND) has been shown to reduce distress in children undergoing painful procedures such as dental work and intravenous insertion. However, no large study has explored IND for laceration repair. In order for research to change the way we care for children, a large study that enrolls children across many paediatric EDs needs to be performed. The first step is to conduct a smaller study to identify the safest and most effective dose. The proposed study plans to enroll 55 children age 1-10 years who require laceration repair.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Dexmedetomidine

Trials testing the same drug.

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