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Completed

NCT Number: NCT02420002

Pediatric Emergency Suture Care: a 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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of MEOPA during suturing

Drug

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

Use of Hypnosis during suturing

Other

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 removal

Procedure

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

Primary outcomes

  1. 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.
  2. The FLACC score

    Time frame: day 0, during anesthetic injection

Secondary outcomes

  1. 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

  2. The EVENDOL score

    Time frame: day 0, during anesthetic injection

  3. 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

  4. 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

  5. MEOPA use

    Time frame: day 0

    measured as litres/minute x minutes of administration

  6. Qualitative scale for general suturing conditions

    Time frame: day 0

    classified as verg good, good, correct, or bad

  7. Use of physical restraint? yes/no

    Time frame: day 0

  8. Procedure failure: yes/non

    Time frame: day 0

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

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

    Time frame: day 0

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

    Time frame: day 0

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

    Time frame: day 0

    Only one VAS per child

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

    Time frame: during stitch removal (days 6 to 15)

  13. The EVENDOL scale for pain

    Time frame: during stitch removal (days 6 to 15)

  14. The FLACC scale for pain

    Time frame: during stitch removal (days 6 to 15)

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

    Time frame: during stitch removal (days 6 to 15)

  16. 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

  17. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: Hypno-Mo

Important dates

Study start
2016
Primary completion
2024
Study completion
2025
First posted
Apr 17, 2015
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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