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Pediatric Emergency Suture Care: a Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA (Hypno-Mo)

Primary Purpose

Wounds, Nonpenetrating

Status

Recruiting

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Use of MEOPA during suturing

Use of Hypnosis during suturing

Stitch removal

About this trial

This is an interventional treatment trial for Wounds, Nonpenetrating

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHRU de Nîmes - Hôpital Universitaire CarémeauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care (MEOPA)

Experimental arm (Hypnosis)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

The FLACC score

Secondary Outcome Measures

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

Score varying from 0.0 to 10.0

The EVENDOL score

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

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

MEOPA use

measured as litres/minute x minutes of administration

Qualitative scale for general suturing conditions

classified as verg good, good, correct, or bad

Use of physical restraint? yes/no

Procedure failure: yes/non

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

Visual analog scale for operator's perception of the ease of the procedure

Visual analog scale for parental satisfaction concerning pain care and comfort during suturing

Only one VAS per child

Visual analog scale for pain (only for children over 6)

The EVENDOL scale for pain

The FLACC scale for pain

Visual analog scale for operator's perception of the ease of stich removal

the child's behaviour during stitch removal

classified as: calm; afraid but capable of self-control; complementary means required

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.

Full Information

NCT ID

NCT02420002

First Posted

April 14, 2015

Last Updated

October 10, 2023

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT02420002

Brief Title

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

Acronym

Hypno-Mo

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 25, 2016 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds, Nonpenetrating

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual care (MEOPA)

Arm Type

Active Comparator

Arm Description

Arm Title

Experimental arm (Hypnosis)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Use of MEOPA during suturing

Other Intervention Name(s)

equimolar mixture of nitrous oxide and oxygen

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Use of Hypnosis during suturing

Intervention Description

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

Procedure

Intervention Name(s)

Stitch removal

Intervention Description

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

Primary Outcome Measure Information:

Title

Failure of pain control: yes/no

Description

Time Frame

baseline (day 0)

Title

The FLACC score

Time Frame

day 0, during anesthetic injection

Secondary Outcome Measure Information:

Title

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

Description

Score varying from 0.0 to 10.0

Time Frame

day 0, during anesthetic injection

Title

The EVENDOL score

Time Frame

day 0, during anesthetic injection

Title

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

Description

Time Frame

day 0

Title

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

Description

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

Time Frame

day 0

Title

MEOPA use

Description

measured as litres/minute x minutes of administration

Time Frame

day 0

Title

Qualitative scale for general suturing conditions

Description

classified as verg good, good, correct, or bad

Time Frame

day 0

Title

Use of physical restraint? yes/no

Time Frame

day 0

Title

Procedure failure: yes/non

Description

i..e, was it necessary to resort to complementary means in order to perform the suture?

Time Frame

day 0

Title

Visual analog scale for operator satisfaction in relation to the performed procedure

Time Frame

day 0

Title

Visual analog scale for operator's perception of the ease of the procedure

Time Frame

day 0

Title

Visual analog scale for parental satisfaction concerning pain care and comfort during suturing

Description

Only one VAS per child

Time Frame

day 0

Title

Visual analog scale for pain (only for children over 6)

Time Frame