Using melatonin to prevent agitation in children after surgery
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.
PHASE3 · Rigshospitalet, Denmark · NCT05541276
This study tests if giving melatonin to young children after surgery can help prevent confusion and restlessness as they wake up from anesthesia.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen, Capital Region) |
| Trial ID | NCT05541276 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of intravenous melatonin to prevent postoperative agitation and emergence delirium in children aged 1-6 years undergoing elective surgeries with general anesthesia. The study aims to determine the safety and efficacy of melatonin in reducing behavioral disturbances that can occur during early recovery from anesthesia. Participants will receive melatonin or an isotonic sodium chloride solution during their procedure, and the outcomes will be assessed to evaluate the effectiveness of melatonin in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-6 years scheduled for elective surgeries lasting at least 30 minutes under general anesthesia.
Not a fit: Patients with known allergies to melatonin or those currently taking melatonin daily may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative agitation and improve recovery experiences for children.
How similar studies have performed: Previous studies have shown promising results with melatonin in reducing emergence agitation in pediatric patients, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 1-6 years * Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia maintained with sevoflurane Exclusion Criteria: * Any known allergy or contraindication to study treatment or excipåients * Current daily medication with melatonin
Where this trial is running
Copenhagen, Capital Region
- Department of Anesthesiology, Juliane Marie Center, Rigshospitalet — Copenhagen, Capital Region, Denmark (RECRUITING)
Study contacts
- Principal investigator: Arash L Afshari, MD, PhD — Rigshospitalet, Denmark
- Study coordinator: Anne Louise B Garioud, MD
- Email: anne.louise.de.barros.garioud@regionh.dk
- Phone: +4535456243
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.
Conditions: Emergence Delirium, Anesthesia, Melatonin, Sevoflurane, Postoperative Pain, Child, PONV