NCT05223010

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2022

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

January 7, 2022

Last Update Submit

October 10, 2023

Conditions

Emergence Agitation

Keywords

melatoninemergence agitation

Outcome Measures

Primary Outcomes (1)

  • emergence behaviour

    change from baseline on a 5 point scale

    5 min, 15 min and 30 min after arrival to recovery

Secondary Outcomes (1)

  • yale preoperative anxiety scale

    before administration of oral premedication and before anaesthesia induction

Study Arms (3)

1

ACTIVE COMPARATOR

39 participant will receive melatonin 0.05 mg/kg

Drug: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kgDrug: Sevoflurane

2

ACTIVE COMPARATOR

39 participant will receive melatonin 0.2 mg/kg

Drug: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kgDrug: Sevoflurane

3

ACTIVE COMPARATOR

39 participant will receive melatonin 0.4 mg/kg

Drug: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kgDrug: Sevoflurane

Interventions

Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kgDRUG

will be administered 1 hour before arrival to operating room

1
Melatonin 5 MG/15 ML Oral Solution 0.2mg/kgDRUG

will be administered 1 hour before arrival to operating room

2
Melatonin 5 MG/15 ML Oral Solution 0.4mg/kgDRUG

will be administered 1 hour before arrival to operating room

3
SevofluraneDRUG

for anaesthesia induction 3-8 MAC

123

Eligibility Criteria

Age4 Years - 8 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsinguinal hernia is common in males
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, University Hospitals

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

MelatoninSolutionsSevoflurane

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPharmaceutical PreparationsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 7, 2022

First Posted

February 3, 2022

Study Start

January 30, 2022

Primary Completion

June 2, 2022

Study Completion

December 3, 2022

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)