MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05541276

Acronym

MELA-PAED

Enrollment

676

Registered

2022-09-15

Start date

2025-01-21

Completion date

2027-04-01

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Keywords

Anesthesia, Melatonin, Sevoflurane, Postoperative Pain, Child, PONV

Brief summary

Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.

Interventions

DRUGMelatonin

Melatonin for injection 1 mg/mL

DRUGIsotonic sodium chloride solution

Sodium chloride 0.9 % for injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 6 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of emergence agitation	Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).	Participants will be assessed on Watcha scale repeatedly ever 15 min during their stay at the Post-Anesthetic Care Unit. The variable is dichotomous: any score \>2= "Yes" and no score \<=2 = "No"

Secondary

Measure	Time frame	Description
Opioid consumption	Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).	The total amount of opioids administered for postoperative pain in the PACU will be evaluated as units of morphine equivalents per kg. No more than 35 % of the popu-lation is expected to receive postoperative opioids in a range of approximately 10-100 µg/kg.
Non-serious Adverse Events (AE)	From enrolment to the trial until 24-hour follow-up.	Any untoward medical occurrence not considered serious.

Countries

Denmark

Contacts

CONTACTAnne Louise B Garioud, MD

anne.louise.de.barros.garioud@regionh.dk+4535456243

STUDY_DIRECTORArash L Afshari, MD, PhD

Rigshospitalet, Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026