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

Rigshospitalet

Status and phase: Enrolling; Phase 3

Conditions: Emergence Delirium

Treatments: Drug: Isotonic sodium chloride solution; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05541276

20211125

2021-006464-24 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

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.

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Isotonic sodium chloride solution