Comparing pain relief methods for pediatric wound suturing
Suture Care in the Pediatric Emergency Department: a Randomized Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA
This study tests whether using a mix of nitrous oxide and oxygen or hypnosis helps kids feel less pain during stitches in the emergency room.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes Cedex 09) |
| Trial ID | NCT02420002 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two pain management techniques for children undergoing suturing in an emergency department. One group receives an equimolar mixture of nitrous oxide and oxygen (MEOPA), while the other group is treated with hypnosis, with MEOPA available if needed. The study aims to assess pain control using various validated scales, the duration of the procedure, and the overall satisfaction of both the medical staff and the parents. It also examines the conditions under which suturing and suture removal occur, including any complications related to the treatments used.
Who should consider this trial
Good fit: Ideal candidates are children requiring sutures for nonpenetrating wounds who are consulting in the emergency department.
Not a fit: Patients who are not eligible due to participation in another study or those who refuse to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and less invasive method for managing pain in pediatric patients during wound suturing.
How similar studies have performed: Previous studies have shown promising results in using hypnosis for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nîmes Cedex 09
- CHRU de Nîmes - Hôpital Universitaire Carémeau — Nîmes Cedex 09, France (Recruiting)
Study contacts
- Principal investigator: Philippe Fournier, MD — Centre Hospitalier Universitaire de Nîmes
- Study coordinator: Philippe Fournier, MD
- Email: philippe.fournier@chu-nimes.fr
- Phone: +33.(0)4.66.68.30.50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.