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

NCT02420002 | Completed Phase 4

• 2 other identifiers: LOCAL/2013/PF-012014-002180-16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wounds, Nonpenetrating

Outcome Measures

Primary Outcomes (2)

• Failure of pain control: yes/no

  Failure of pain control as defined by: * The conversion of the procedure to MEOPA (for the hypnosis arm) or to sedation (for the MEOPA arm. Conversion is decided if the FLACC score at the end of the induction phase of hypnosis or for MEOPA is greater than 3 (1-3 are equivalent to mild discomfort). * Or a FLACC score\> 3 during the period between anesthetic injection and the end of the suture.

  baseline (day 0)

• The FLACC score

  day 0, during anesthetic injection

Secondary Outcomes (17)

• Pain as measured via a VAS score for children over six years of age

  day 0, during anesthetic injection

• The EVENDOL score

  day 0, during anesthetic injection

• time lapsed between the beginning of the procedure and end of the suture

  day 0

• time lapsed between the beginning of the procedure and the beginning of the suture

  day 0

• MEOPA use

  day 0

Study Arms (2)

Usual care (MEOPA)

ACTIVE COMPARATOR

Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing. Intervention: Use of MEOPA during suturing Intervention: Stitch removal

Drug: Use of MEOPA during suturing; Procedure: Stitch removal

Experimental arm (Hypnosis)

EXPERIMENTAL

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 will therefore take place under hypnosis (and MEOPA if necessary). Intervention: Use of Hypnosis during suturing Intervention: Stitch removal

Other: Use of Hypnosis during suturing; Procedure: Stitch removal

Interventions

Use of MEOPA during suturing DRUG

Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing of a wound.

Also known as: equimolar mixture of nitrous oxide and oxygen

Usual care (MEOPA)

Use of Hypnosis during suturing OTHER

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).

Experimental arm (Hypnosis)

Stitch removal PROCEDURE

6 to 15 days after the initial suturing, stitches will be removed according to usual procedures.

Experimental arm (Hypnosis); Usual care (MEOPA)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The patient was informed about the implementation of the study, its objectives, constraints and patient rights
• The legal representative of the patient must have given free and informed consent and signed the consent
• The patient must be affiliated with or beneficiary of a health insurance plan
• The patient is available for 15 days of follow-up
• The patient is consulting in the emergency department for a wound requiring the completion of a suture and for which the operator considers that the use of nitrous oxide is necessary and possible.

You may not qualify if:

• The patient is participating in another interventional study
• The patient has participated in another interventional study in the last 3 months
• The patient and/or his/her parents (or legal representative) refuses to sign the consent
• It proves impossible to correctly inform the patient and / or his/her parents (or legal representative)
• The patient has a contra-indication (or an incompatible drug combination) for a treatment required in this study (MEOPA): intracranial hypertension, impaired consciousness, pneumothorax, high rate oxygen-dependence, facial trauma preventing mask application.
• The patient has a condition that makes hypnosis impossible: e.g. encephalopathy, deafness, communication disorders, does not speak French
• Suture requiring surgical exploration or an operating room, or general anesthesia or an ears-nose-throat, orthopedic or visceral surgeon (e.g. wound of the oral cavity, abdominal or thoracic penetrating wound, finger or palm wound requiring exploration by an orthopaedist)
• Fractures associated with wound
• Use of level II/III analgesics before the beginning of pre-suture care support

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Wounds, Nonpenetrating

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Philippe Fournier, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: October 25, 2016
• Primary Completion: December 31, 2024
• Study Completion: March 24, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)