Impact of Sedative and Anxiolytic Medication on Children's Experience After Anesthesia
" Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia " The pediaPREM Study.
This study is testing if giving kids aged 7 to 18 a sedative before surgery can help reduce their anxiety and improve their recovery after anesthesia compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05681572 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of sedative and anxiolytic premedication on the perioperative experiences of children aged 7 to 18 undergoing general anesthesia for surgery. It aims to determine whether pharmacologic premedication, specifically midazolam or dexmedetomidine, can reduce anxiety and improve postoperative outcomes compared to a placebo. Participants will be randomly assigned to receive either the medication or placebo, and their experiences will be assessed using self-report questionnaires. The study addresses a gap in existing research regarding older children and the efficacy of premedication.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 18 who are scheduled for surgery requiring general anesthesia and can complete a self-questionnaire in French.
Not a fit: Patients with pre-existing anxiety disorders, cognitive impairments, or those on psychotropic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved perioperative experiences for children undergoing surgery, reducing anxiety and postoperative complications.
How similar studies have performed: While studies have shown benefits of premedication in younger children, this approach in older children is less explored, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject over 7 and under 18 years of age * Subjects who are scheduled for surgery * Subject who will be under general anesthesia * Subject able to complete a self-questionnaire in French Exclusion Criteria: * Subject who has already participated in the pediaPREM study * Subject with a treated anxiety disorder * Subject with cognitive disorders * Subject suffering from chronic pain (outside the operated area) * Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment * Subject suffering from mental retardation * Subjects receiving psychotropic treatment * Subject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.) * Subject with a contra-indication to midazolam and its excipients * Subject with a contra-indication to dexmedetomidine and its excipients * Subjects who need to receive intravenous alpha agonist in perioperative * Subjects requiring emergency intervention * Subjects requiring preoperative hypnosis * Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...) * Subject having had a surgical intervention in the month preceding the inclusion. * Subject who will have an iterative surgical intervention within 15 days (removal of material, burns etc...) * Subjects who are scheduled for surgery as part of oncology management * Pregnant or breastfeeding woman * Subject whose two parents have not signed a written informed consent * Subjects who are not affiliated with or benefiting from a social security plan
Where this trial is running
Montpellier
- Uhmontpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Sophie BRINGUIER, PHD
- Email: s-bringuierbranchereau@chu-montpellier.fr
- Phone: 0467338661
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.