Clinical trial NCT05541276: MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Official title: MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children. The MELA-PAED Trial: a Randomized, Double-blind, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Emergence Delirium
Keywords: Anesthesia
Melatonin
Sevoflurane
Postoperative Pain
Child
PONV
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Sygehus Lillebaelt
name: University of Copenhagen
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2022-09-15
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of emergence agitation
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
Secondary outcomes:
measure: Opioid consumption
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Non-serious Adverse Events (AE)
timeFrame: From enrolment to the trial until 24-hour follow-up.
Other outcomes:
measure: Serious Adverse Events (SAE)
timeFrame: SAEs will be assessed from enrolment until 30 days after intervention.
measure: Postoperative pain
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Postoperative nausea and vomiting (PONV)
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Time to administration of opioid
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Need for rescue medication
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Time to awakening in PACU
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Time to postoperative oral intake
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Time for discharge readiness
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Emergence delirium
timeFrame: Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).
measure: Readmissions within 30 days
timeFrame: From day of discharge + 30 days.
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anesthesiology, Juliane Marie Center, Rigshospitalet
state: Capital Region
Study officials:
affiliation: Rigshospitalet, Denmark
name: Arash L Afshari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: