MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

NCT05541276 | Recruiting Phase 3 DMC

• 2 other identifiers: 202111252021-006464-24
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium

Keywords

Anesthesia; Melatonin; Sevoflurane; Postoperative Pain; Child; PONV

Outcome Measures

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"

  Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).

Secondary Outcomes (2)

• Opioid consumption

  Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).

• Non-serious Adverse Events (AE)

  From enrolment to the trial until 24-hour follow-up.

Other Outcomes (10)

• Serious Adverse Events (SAE)

  SAEs will be assessed from enrolment until 30 days after intervention.

• Postoperative pain

  Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).

• Postoperative nausea and vomiting (PONV)

  Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU).

Study Arms (2)

Melatonin

EXPERIMENTAL

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.

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

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.

Drug: Isotonic sodium chloride solution

Interventions

Melatonin DRUG

Melatonin for injection 1 mg/mL

Melatonin

Isotonic sodium chloride solution DRUG

Sodium chloride 0.9 % for injection

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 1-6 years
• Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia maintained with sevoflurane

You may not qualify if:

• Any known allergy or contraindication to study treatment or excipåients
• Current daily medication with melatonin

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Sygehus Lillebaelt: collaborator
• University of Copenhagen: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (1)

Department of Anesthesiology, Juliane Marie Center, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Melatonin; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Arash L Afshari, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Louise B Garioud, MD

CONTACT

+4535456243; anne.louise.de.barros.garioud@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Associated Professor

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: January 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

DK (1)