Intranasal Dexmedetomidine Dose-finding Study

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• children age 1-10 years who present to the ED with an isolated laceration < 5 cm

• deemed to require suture repair based on the opinion of the treating physician

• predicted to resist positioning for laceration repair based on the opinion of the caregiver

Exclusion Criteria:

• laceration repair requiring procedural sedation (without IND) or local nerve block, - other injuries requiring reduction (fracture or dislocation) or repair (nailbed injury or laceration)

• lacerations containing foreign body material (including dirt and debris)

• history of hypersensitivity to dexmedetomidine

• occlusion of at least one nare due to mucus, polyps, septal deviation, etc.

• concomitant use of an alpha 2-adrenergic receptor agonist

• bradycardia or hypotension for age (possible transient but clinically insignificant adverse effects of dexmedetomidine)