NCT02420002

Pediatric Emergency Suture Care: a Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Wounds, Nonpenetrating

Interventions

Type	Name	Description
DRUG	Use of MEOPA during suturing	Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing of a wound.
OTHER	Use of Hypnosis during suturing	Patients randomized to this arm will receive usual care as in the other arm, but before MEOPA inhalation is started, hypnosis will be tried. The local anesthetic injection and suturing of the wound will therefore take place under hypnosis (and MEOPA if necessary).
PROCEDURE	Stitch removal	6 to 15 days after the initial suturing, stitches will be removed according to usual procedures.

Timeline

• Start date: 2016-10-25
• Primary completion: 2024-12-31
• Completion: 2025-03-24
• First posted: 2015-04-17
• Last updated: 2025-11-17

Locations

1 site across 1 country: France