MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
ConditionEmergence Delirium
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-6
SponsorArash Afshari
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients aged 1-6 years
Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia
Disqualifiers
Any known allergy or contraindication to study treatment or excipåients
Current daily medication with melatonin
Trial design
Design model
Parallel
Treatments tested in this trial
Melatonin
DrugMelatonin for injection 1 mg/mL
Isotonic sodium chloride solution
DrugSodium chloride 0.9 % for injection
Treatment groups
676 Participants
are divided into 2 treatment groupsGroup A: MelatoninExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence 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).Secondary outcomes
1
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).2
Non-serious Adverse Events (AE)
Any untoward medical occurrence not considered serious.
Time frame
From enrolment to the trial until 24-hour follow-up.Other outcomes
1
Serious Adverse Events (SAE)
We will use the International Conference on Harmonization of technical require-ments for registration of pharmaceuticals for human use-Good Clinical Practice (ICH-GCP) definition of a serious adverse event, which is any untoward medical occurrence that resulted in death, was life-threatening, re-quired hospitalization or prolonging of existing hospitalization and resulted in persistent or significant disability or jeopardized the participant.
Time frame
SAEs will be assessed from enrolment until 30 days after intervention.2
Postoperative pain
The incidence of postoperative pain will be assessed in each group according to the FLACC scale, assessed every 15 minutes in PACU. Postoperative pain is defined as any FLACC score \>3.
Time frame
Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).3
Postoperative nausea and vomiting (PONV)
The incidence of PONV will be assessed dichotomously every 15 minutes in PACU. Outcome assessors will observe for vomiting. Nausea can be considered present if the participant refuses to eat and other causes are ruled out. There is no adequate PONV assessment tool available. PONV will be considered present if any assess-ment during PACU stay is "Yes".
Time frame
Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).4
Time to administration of opioid
Time from end of anesthesia to the time point at which the first dose of opioid is administered in PACU. Not all participants (expectedly up to approximately 35%) will receive opioids in PACU.
Time frame
Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).Sponsors and contacts
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Arash Afshari
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Sygehus Lillebaelt
Collaborator
University of Copenhagen
Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Source ClinicalTrials.gov