Using melatonin to prevent agitation in children after surgery
Official title: MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.
Run by Copenhagen University Hospital, Rigshospitalet · NCT05541276 · Data updated 2026-11-12
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 | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 6 Years |
| Sex | All |
| Enrollment | 676 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen, Capital Region) |
| Status | Recruiting |
| Started | January 21, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT05541276 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with known allergies to melatonin or those currently taking melatonin daily may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with melatonin in reducing emergence agitation in pediatric patients, indicating potential for success in this trial.
Who can join: the full rules
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 Exclusion Criteria: * Any known allergy or contraindication to study treatment or excipåients * Current daily medication with melatonin
Where it's running
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Department of Anesthesiology, Juliane Marie Center, Rigshospitalet
Copenhagen, Capital Region, Denmark Recruiting
Study contacts
- Study coordinator: Anne Louise B Garioud, MD
- Email: anne.louise.de.barros.garioud@regionh.dk
- Phone: +4535456243
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Live parent-child video interaction or cartoon watching to ease emergence agitation in preschoolers
This study tests whether live video calls with a parent or watching cartoons during preoperative transfer can reduce anxiety before anesthesia and agitation after surgery in 2- to 6-year-olds undergoing elective procedures.
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Oral vs IV Magnesium for Emergence Delirium in Children after Adenotonsillectomy
This trial tests whether giving magnesium by mouth before surgery or by IV during surgery can reduce emergence delirium in children aged 4–7 undergoing adenotonsillectomy with sevoflurane anesthesia.
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This trial will test whether an ultrasound-guided greater auricular nerve block can reduce agitation and pain when children wake up after microscopic middle ear surgery.
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Dexmedetomidine–midazolam versus ketamine–midazolam for emergence delirium in children
This test compares dexmedetomidine plus midazolam against ketamine plus midazolam to see which better prevents emergence delirium in children having heart catheterization under general anesthesia.
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Remimazolam with sevoflurane to reduce wake-up agitation in children after neurosurgery.
This trial will test whether adding a single bolus of remimazolam to sevoflurane anesthesia lowers the chance that children ages 1–6 become agitated as they wake up from neurosurgery.
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Diagnosing neurocognitive complications during surgery using EEG
This study is testing if using EEG during surgery can help doctors spot early signs of cognitive problems, like delirium, in adults having non-cardiac surgeries.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.