Intranasal Dexmedetomidine Dose-finding Study

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.

Timeline

Start

2020-02-20

Primary completion

2022-03-30

Completion

2022-03-30

Publications

• Poonai N, Sabhaney V, Ali S, Stevens H, Bhatt M, Trottier ED, Brahmbhatt S, Coriolano K, Chapman A, Evans N, Mace C, Creene C, Meulendyks S, Heath A. Optimal Dose of Intranasal Dexmedetomidine for Laceration Repair in Children: A Phase II Dose-Ranging Study. Ann Emerg Med. 2023 Aug;82(2):179-190. doi: 10.1016/j.annemergmed.2023.01.023. Epub 2023 Mar 3.

Drugs

Indications

No indication recorded.