Pediatric Emergency Suture Care: a Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA — Hypno-Mo  

Wounds, Nonpenetrating Clinical Trial

Official title: Suture Care in the Pediatric Emergency Department: a Randomized Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA

Status Recruiting

Clinical Trial Summary

This is a therapeutic, randomized, single center, two parallel-arm trial comparing pain control via "MEOPA" (equimolar mixture of nitrous oxide and oxygen) in one arm versus "Hypnosis + MEOPA if needed" in the second arm.

The primary objective is to compare the two study arms in terms of efficacity for pain control according to the FLACC (Face Legs Activity Cry Consolability Observational Tool) behavioural scale.

Clinical Trial Description

The secondary objectives of this study are to compare the two study arms in terms of:

• Efficacity for pain relief during suturing according to other validated scales (a visual analog scale (VAS), the EVENDOL (Evaluation Enfant Douleur) scale);

• the duration of the procedure, the time between the start of the care process for pain (hypnosis or nitrous oxide) and the beginning of the suture;

• the amount of nitrous oxide administered;

• the conditions under which suturing takes place, in terms of (i) the general conditions of implementation, (ii) the need to use physical restraint, (iii) failure of the procedure and the need to resort to supplementary means of anesthesia, (iv) satisfaction of the operator and his/her perceived ease of operations, (v) satisfaction of the parents;

• the behavior of the patient during removal of the suture;

• the conditions under which suture removal takes place;

• complications related to the used treatments. ;

Related Conditions & MeSH terms

• Emergencies
• Wounds, Nonpenetrating

• NCT number: NCT02420002
• Study type: Interventional
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Philippe Fournier, MD
• Phone: +33.(0)4.66.68.30.50
• Email: philippe.fournier@chu-nimes.fr
• Status: Recruiting
• Phase: Phase 4
• Start date: October 25, 2016
• Completion date: January 2025