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

Wounds, Nonpenetrating Clinical Trial

— Hypno-Mo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02420002
• Other study ID #: LOCAL/2013/PF-01
• Secondary ID: 2014-002180-16
• Status: Recruiting
• Phase: Phase 4
• Start date: October 25, 2016
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Philippe Fournier, MD
• Phone: +33.(0)4.66.68.30.50
• Email: philippe.fournier[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Wounds, Nonpenetrating

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	The FLACC score		day 0, during anesthetic injection
Secondary	Pain as measured via a VAS score for children over six years of age	Score varying from 0.0 to 10.0	day 0, during anesthetic injection
Secondary	The EVENDOL score		day 0, during anesthetic injection
Secondary	time lapsed between the beginning of the procedure and end of the suture	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	day 0
Secondary	time lapsed between the beginning of the procedure and the beginning of the suture	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	day 0
Secondary	MEOPA use	measured as litres/minute x minutes of administration	day 0
Secondary	Qualitative scale for general suturing conditions	classified as verg good, good, correct, or bad	day 0
Secondary	Use of physical restraint? yes/no		day 0
Secondary	Procedure failure: yes/non	i..e, was it necessary to resort to complementary means in order to perform the suture?	day 0
Secondary	Visual analog scale for operator satisfaction in relation to the performed procedure		day 0
Secondary	Visual analog scale for operator's perception of the ease of the procedure		day 0
Secondary	Visual analog scale for parental satisfaction concerning pain care and comfort during suturing	Only one VAS per child	day 0
Secondary	Visual analog scale for pain (only for children over 6)		during stitch removal (days 6 to 15)
Secondary	The EVENDOL scale for pain		during stitch removal (days 6 to 15)
Secondary	The FLACC scale for pain		during stitch removal (days 6 to 15)
Secondary	Visual analog scale for operator's perception of the ease of stich removal		during stitch removal (days 6 to 15)
Secondary	the child's behaviour during stitch removal	classified as: calm; afraid but capable of self-control; complementary means required	during stitch removal (days 6 to 15)
Secondary	The presence/absence of complications	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.	day 0