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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
676
Melatonin for injection 1 mg/mL
Sodium chloride 0.9 % for injection
Department of Anesthesiology, Juliane Marie Center, Rigshospitalet
Copenhagen, Capital Region, Denmark
RECRUITINGIncidence of emergence agitation
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"
Time frame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
Opioid consumption
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.
Time frame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
Non-serious Adverse Events (AE)
Any untoward medical occurrence not considered serious.
Time frame: From enrolment to the trial until 24-hour follow-up.
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