MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

Phase 3

Recruiting

• Conditions: Emergence Delirium
• Interventions: Drug: Isotonic sodium chloride solution; Drug: Melatonin

• Registration Number: NCT05541276
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Status Verified: 2025-01
• Study Start: 2025-01-21
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24
• Primary Completion: 2026-12-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Isotonic sodium chloride solution	Participants receive isotonic sodium chloride (9mg/mL) intravenously once approximately 30 minutes before end of surgical procedure in a volume equivalent to the melatonin group for the same weight.
Melatonin	Melatonin	Participants receive melatonin solution for injection 1 mg/mL in a dosage of 0.15 mg/kg body weight as a single intravenous injection approximately 30 minutes before end of surgical procedure.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Anesthesiology, Juliane Marie Center, Rigshospitalet; 🇩🇰 Copenhagen, Capital Region, Denmark