Melatonin for Pediatric Emergence Agitation

Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics

efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries

Study Overview

• Status: Completed
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg; Drug: Sevoflurane; Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg; Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg

Detailed Description

Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.

Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32511
      • Faculty of Medicine, University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASA I
• scheduled for unilateral inguinal herniorrhaphy
• parents conscent

Exclusion Criteria:

• allergy to this study drug
• Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 39 participant will receive melatonin 0.05 mg/kg	Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg; will be administered 1 hour before arrival to operating room; Drug: Sevoflurane; for anaesthesia induction 3-8 MAC
Active Comparator: 2; 39 participant will receive melatonin 0.2 mg/kg	Drug: Sevoflurane; for anaesthesia induction 3-8 MAC; Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg; will be administered 1 hour before arrival to operating room
Active Comparator: 3; 39 participant will receive melatonin 0.4 mg/kg	Drug: Sevoflurane; for anaesthesia induction 3-8 MAC; Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg; will be administered 1 hour before arrival to operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
emergence behaviour	change from baseline on a 5 point scale	5 min, 15 min and 30 min after arrival to recovery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
yale preoperative anxiety scale	3 domain scale	before administration of oral premedication and before anaesthesia induction

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2022
• Primary Completion (Actual): June 2, 2022
• Study Completion (Actual): December 3, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 22, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: melatonin; emergence agitation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Protective Agents; Anesthetics, Inhalation; Antioxidants; Melatonin; Pharmaceutical Solutions; Sevoflurane
• Other Study ID Numbers: 1/2022ANET3-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No