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

November 14, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Nîmes, France, 30029
        • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
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 Names:
  • equimolar mixture of nitrous oxide and oxygen
Procedure: Stitch removal
6 to 15 days after the initial suturing, stitches will be removed according to usual procedures.
Experimental: 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
Procedure: Stitch removal
6 to 15 days after the initial suturing, stitches will be removed according to usual procedures.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Failure of pain control: yes/no
Time Frame: 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.
baseline (day 0)
The FLACC score
Time Frame: day 0, during anesthetic injection
day 0, during anesthetic injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain as measured via a VAS score for children over six years of age
Time Frame: day 0, during anesthetic injection
Score varying from 0.0 to 10.0
day 0, during anesthetic injection
The EVENDOL score
Time Frame: day 0, during anesthetic injection
day 0, during anesthetic injection
time lapsed between the beginning of the procedure and end of the suture
Time Frame: 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
day 0
time lapsed between the beginning of the procedure and the beginning of the suture
Time Frame: 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
day 0
MEOPA use
Time Frame: day 0
measured as litres/minute x minutes of administration
day 0
Qualitative scale for general suturing conditions
Time Frame: day 0
classified as verg good, good, correct, or bad
day 0
Use of physical restraint? yes/no
Time Frame: day 0
day 0
Procedure failure: yes/non
Time Frame: day 0
i..e, was it necessary to resort to complementary means in order to perform the suture?
day 0
Visual analog scale for operator satisfaction in relation to the performed procedure
Time Frame: day 0
day 0
Visual analog scale for operator's perception of the ease of the procedure
Time Frame: day 0
day 0
Visual analog scale for parental satisfaction concerning pain care and comfort during suturing
Time Frame: day 0
Only one VAS per child
day 0
Visual analog scale for pain (only for children over 6)
Time Frame: during stitch removal (days 6 to 15)
during stitch removal (days 6 to 15)
The EVENDOL scale for pain
Time Frame: during stitch removal (days 6 to 15)
during stitch removal (days 6 to 15)
The FLACC scale for pain
Time Frame: during stitch removal (days 6 to 15)
during stitch removal (days 6 to 15)
Visual analog scale for operator's perception of the ease of stich removal
Time Frame: during stitch removal (days 6 to 15)
during stitch removal (days 6 to 15)
the child's behaviour during stitch removal
Time Frame: during stitch removal (days 6 to 15)
classified as: calm; afraid but capable of self-control; complementary means required
during stitch removal (days 6 to 15)
The presence/absence of complications
Time Frame: 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.
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe Fournier, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2013/PF-01
  • 2014-002180-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wounds, Nonpenetrating

Clinical Trials on Use of MEOPA during suturing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings