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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Apr 16, 2015

Keywords

ClinConnect Summary

This clinical trial is looking at how well two different methods can help control pain in children who need stitches for non-penetrating wounds. One group of children will receive a treatment called MEOPA, which is a mix of nitrous oxide (often known as laughing gas) and oxygen to help ease pain. The other group will use hypnosis to help reduce pain, with the option to use MEOPA if necessary. The researchers want to see which method works better in making kids feel more comfortable during the procedure.

To be part of this trial, children should be between the ages of about 4 to 17 years and need to be treated in the emergency department for a wound requiring stitches. Their parents or guardians must give consent for them to participate. It's important that the child is able to follow up for 15 days after the treatment. However, some children may not be eligible if they have certain medical conditions or are part of another study. Participants can expect close attention during the trial to ensure their comfort and safety as they receive care.

Gender

ALL

Eligibility 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