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MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

Phase 3
Recruiting
Conditions
Emergence Delirium
Interventions
Drug: Isotonic sodium chloride solution
Registration Number
NCT05541276
Lead Sponsor
Rigshospitalet, Denmark
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
400
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboIsotonic sodium chloride solutionParticipants 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.
MelatoninMelatoninParticipants 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.
Primary Outcome Measures
NameTimeMethod
Incidence of emergence agitationUp to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).

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"

Secondary Outcome Measures
NameTimeMethod
Opioid consumptionUp to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).

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.

Non-serious Adverse Events (AE)From enrolment to the trial until 24-hour follow-up.

Any untoward medical occurrence not considered serious.

Trial Locations

Locations (1)

Department of Anesthesiology, Juliane Marie Center, Rigshospitalet

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Copenhagen, Capital Region, Denmark

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