Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 1 Year to 6

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

PhasePhase 3
Study typeInterventional
Ages1 Year to 6 Years
SexAll
Enrollment676 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen, Capital Region)
StatusRecruiting
StartedJanuary 21, 2025
Main results expectedMarch 1, 2027
Study endsApril 1, 2027
Registry record updatedAugust 18, 2026
Trial IDNCT05541276 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

  • Department of Anesthesiology, Juliane Marie Center, Rigshospitalet
    Copenhagen, Capital Region, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.