MELA-PAED: MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05541276

Collaborator

Sygehus Lillebaelt (Other), University of Copenhagen (Other), Copenhagen Trial Unit, Center for Clinical Intervention Research (Other)

400

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emergence Delirium	Drug: Melatonin Drug: Isotonic sodium chloride solution	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Jan 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Melatonin Melatonin for injection 1 mg/mL
Placebo Comparator: Placebo 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.	Drug: Isotonic sodium chloride solution Sodium chloride 0.9 % for injection Other Names: Normal saline

Arm

Intervention/Treatment

Experimental: 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.

Drug: Melatonin

Melatonin for injection 1 mg/mL

Placebo Comparator: Placebo

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.

Drug: Isotonic sodium chloride solution

Sodium chloride 0.9 % for injection

Other Names:

Normal saline

Outcome Measures

Primary Outcome Measures

Incidence of emergence agitation [Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit.]
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"