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

Phase 4

Recruiting

• Conditions: Wounds, Nonpenetrating
• Interventions: Drug: Use of MEOPA during suturing; Other: Use of Hypnosis during suturing; Procedure: Stitch removal

• Registration Number: NCT02420002
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Study Start: 2016-10-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care (MEOPA)	Use of MEOPA during suturing	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
Usual care (MEOPA)	Stitch removal	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
Experimental arm (Hypnosis)	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 will therefore take place under hypnosis (and MEOPA if necessary). Intervention: Use of Hypnosis during suturing Intervention: Stitch removal
Experimental arm (Hypnosis)	Stitch removal	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

Primary Outcome Measures

Name	Time	Method
The FLACC score	day 0, during anesthetic injection
Failure of pain control: yes/no	baseline (day 0)	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.

Secondary Outcome Measures

Name	Time	Method
The EVENDOL score	day 0, during anesthetic injection
The FLACC scale for pain	during stitch removal (days 6 to 15)
MEOPA use	day 0	measured as litres/minute x minutes of administration
Qualitative scale for general suturing conditions	day 0	classified as verg good, good, correct, or bad
Pain as measured via a VAS score for children over six years of age	day 0, during anesthetic injection	Score varying from 0.0 to 10.0
time lapsed between the beginning of the procedure and end of the suture	day 0	Beginning of procedure: defined as either the beginning of MEOPA administration, or the beginning of hypnosis; End of suture: the suture is declared as finished after cleaning the sutured zone, removal of drapes and placement of wound dressing
Visual analog scale for pain (only for children over 6)	during stitch removal (days 6 to 15)
time lapsed between the beginning of the procedure and the beginning of the suture	day 0	Beginning of procedure: defined as either the beginning of MEOPA administration, or the beginning of hypnosis; Beginning of the suture: defined as the beginning of the first stitch
Use of physical restraint? yes/no	day 0
Procedure failure: yes/non	day 0	i..e, was it necessary to resort to complementary means in order to perform the suture?
Visual analog scale for operator satisfaction in relation to the performed procedure	day 0
Visual analog scale for operator's perception of the ease of the procedure	day 0
Visual analog scale for parental satisfaction concerning pain care and comfort during suturing	day 0	Only one VAS per child
The EVENDOL scale for pain	during stitch removal (days 6 to 15)
Visual analog scale for operator's perception of the ease of stich removal	during stitch removal (days 6 to 15)
the child's behaviour during stitch removal	during stitch removal (days 6 to 15)	classified as: calm; afraid but capable of self-control; complementary means required
The presence/absence of complications	day 0	The presence/absence of at least one of the following complications: vomiting, nausea, agitation, imbalance problems, headache, persistant anesthesia at the end of the procedure.

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France