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Wounds, NonpenetratingPhase 4Hypno-MoNCT02420002

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

A Phase 4 study testing Use of MEOPA during suturing, Use of Hypnosis during suturing and Stitch removal in people with Wounds, Nonpenetrating, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 17 years
Conditions the study is for
Wounds, Nonpenetrating
What is being tested?
Use of MEOPA during suturing, Use of Hypnosis during suturing and Stitch removal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
25 Oct 2016to 24 Mar 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029

Other trials in France

About this study

Official title: 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.

Read the 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.
Being tested
Use of MEOPA during suturing, Use of Hypnosis during suturing, Stitch removal
Medical subject headings
Wounds, Nonpenetrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of MEOPA during suturingDrug

    Also called equimolar mixture of nitrous oxide and oxygen

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

  • Use of Hypnosis during suturingOther

    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 removalProcedure or surgery

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

Study groups in NCT02420002
Study groupRoleWhat they receive
Usual care (MEOPA)Active comparatorPatients 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
Receives: Drug: Use of MEOPA during suturing; Procedure: Stitch removal
Experimental arm (Hypnosis)ExperimentalPatients 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
Receives: Other: Use of Hypnosis during suturing; Procedure: Stitch removal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline (day 0)

  2. The FLACC score

    Measured: day 0, during anesthetic injection

Secondary outcomes (17)

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

    Score varying from 0.0 to 10.0

    Measured: day 0, during anesthetic injection

  2. The EVENDOL score

    Measured: day 0, during anesthetic injection

  3. 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

    Measured: day 0

  4. 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

    Measured: day 0

  5. MEOPA use

    measured as litres/minute x minutes of administration

    Measured: day 0

  6. Qualitative scale for general suturing conditions

    classified as verg good, good, correct, or bad

    Measured: day 0

  7. Use of physical restraint? yes/no

    Measured: day 0

  8. Procedure failure: yes/non

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

    Measured: day 0

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

    Measured: day 0

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

    Measured: day 0

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

    Only one VAS per child

    Measured: day 0

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

    Measured: during stitch removal (days 6 to 15)

  13. The EVENDOL scale for pain

    Measured: during stitch removal (days 6 to 15)

  14. The FLACC scale for pain

    Measured: during stitch removal (days 6 to 15)

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

    Measured: during stitch removal (days 6 to 15)

  16. the child's behaviour during stitch removal

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

    Measured: during stitch removal (days 6 to 15)

  17. 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.

    Measured: day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study start25 Oct 2016
  3. Primary completion31 Dec 2024
  4. Study completion24 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02420002
Sponsor's protocol ID
LOCAL/2013/PF-01
Other IDs
2014-002180-16, 2014
Acronym
Hypno-Mo
Status last verified
Nov 2025
First submitted
14 Apr 2015
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Use of MEOPA during suturing, Use of Hypnosis during suturing and Stitch removal in people with Wounds, Nonpenetrating, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure of pain control: yes/no (time frame: baseline (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02420002.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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