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Comparison of the Effect of Two Drugs Melatonin and Midazolam on Abnormal Behaviour in Chilren Coming Out of General Anaesthesia After Surgery.

Comparison of Melatonin Versus Midazolam as Premedicants on Emergence Delirium in Paediatric Surgical Patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/049166
Enrollment
76
Registered
2023-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Melatonin: 0.5mg/kg in syrup form orally, 30-45 mins prior to surgery Control Intervention1: Midazolam: 0.5mg/kg in syrup form orally, 30-45 mins prior to surgery

Sponsors

Department of Anaesthesia and Intensive Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 2- 13 years. Any gender 2.ASA - grade 1 and 2 3.Type of surgery – elective / scheduled surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: 1.Children undergoing emergency procedures 2.Patients with any neurological disorders 3.Patients with neurodevelopmental anomalies 4.Children with history of premature birth 5.Intellectually disabled children 6.Patients with hearing impairment 7.Anticipated duration of surgery > 3 hours. 8.Refusal of parents/ guardians for taking part in the study

Design outcomes

Primary

MeasureTime frame
emergence delirium in children using WATCHA scale - premeditated with oral melatonin or oral midazolam. Timepoint: 10 minutes after extubation in paediatric surgical patients

Secondary

MeasureTime frame
1. To study the role of oral melatonin vs oral midazolam as premedicants in allaying preoperative anxiety by STAI scale. Timepoint: 1 day prior to surgery;2. Impact of preoperative anxiety on emergence delirium using mYPAS scaleTimepoint: 30minutes after extubation

Countries

India

Contacts

Public ContactDr Richa Saroa

Government Medical College and Hospital, Chandigarh

sanjeev_palta@yahoo.com9646121523

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026