Back to resultsMelatonin for Pediatric Emergence Agitation
Primary Purpose
Emergence Agitation
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg
Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg
Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg
Sevoflurane
Sponsored by
About this trial
This is an interventional supportive care trial for Emergence Agitation focused on measuring melatonin, emergence agitation
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
39 participant will receive melatonin 0.05 mg/kg
39 participant will receive melatonin 0.2 mg/kg
39 participant will receive melatonin 0.4 mg/kg
Outcomes
Primary Outcome Measures
emergence behaviour
change from baseline on a 5 point scale
Secondary Outcome Measures
yale preoperative anxiety scale
3 domain scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05223010
Brief Title
Melatonin for Pediatric Emergence Agitation
Official Title
Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2022 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
December 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
Keywords
melatonin, emergence agitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
39 participant will receive melatonin 0.05 mg/kg
Arm Title
2
Arm Type
Active Comparator
Arm Description
39 participant will receive melatonin 0.2 mg/kg
Arm Title
3
Arm Type
Active Comparator
Arm Description
39 participant will receive melatonin 0.4 mg/kg
Intervention Type
Drug
Intervention Name(s)
Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg
Intervention Description
will be administered 1 hour before arrival to operating room
Intervention Type
Drug
Intervention Name(s)
Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg
Intervention Description
will be administered 1 hour before arrival to operating room
Intervention Type
Drug
Intervention Name(s)
Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg
Intervention Description
will be administered 1 hour before arrival to operating room
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
for anaesthesia induction 3-8 MAC
Primary Outcome Measure Information:
Title
emergence behaviour
Description
change from baseline on a 5 point scale
Time Frame
5 min, 15 min and 30 min after arrival to recovery
Secondary Outcome Measure Information:
Title
yale preoperative anxiety scale
Description
3 domain scale
Time Frame
before administration of oral premedication and before anaesthesia induction
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
inguinal hernia is common in males
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine, University Hospitals
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
32511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Melatonin for Pediatric Emergence Agitation
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