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

NCT ID: NCT02420002

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2025-03-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual care (MEOPA)

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

Group Type: ACTIVE_COMPARATOR

Use of MEOPA during suturing

Intervention Type: DRUG

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

Stitch removal

Intervention Type: PROCEDURE

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

Experimental arm (Hypnosis)

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

Group Type: EXPERIMENTAL

Use of Hypnosis during suturing

Intervention Type: 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).

Stitch removal

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: OTHER

Stitch removal

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

Intervention Type: PROCEDURE

Other Intervention Names

equimolar mixture of nitrous oxide and oxygen

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• The patient is participating in another interventional study
• The patient has participated in another interventional study in the last 3 months
• The patient is in an exclusion period determined by a previous study
• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Fournier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

LOCAL/2013/PF-01

Identifier Type: -

Identifier Source: org_study_id

2014-002180-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id