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Comparison of oral midazolam and oral melatonin for sedation and separation anxiety in paediatric patients undergoing surgery

A comparative study of impact of midazolam and melatonin as oral premedications on sedation and separation anxiety in paediatric anaesthesia - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100867
Enrollment
62
Registered
2026-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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: Patients will receive oral melatonin 0.5mg/kg 30 minutes before induction Control Intervention1: Midazolam: Patients will receive oral midazolam 0.5mg/kg 30 minutes before in

Sponsors

Guru Gobind Singh Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age 2-10 years of both genders. Patients belonging to American Society of Anaesthesiologists grade I and II. Cooperative parents willing to give informed consent.

Exclusion criteria

Exclusion criteria: Patients with known allergy to midazolam and/or melatonin. Patients with history of developmental delay or psychiatric illness. Use of psychoactive or sedative drugs within 48 hours prior to surgery. Patients with respiratory or hepatic dysfunction. Emergency surgeries.

Design outcomes

Primary

MeasureTime frame
To compare sedation and ease of separation from parents in paediatric age group before anaesthesia.Timepoint: After 30 mins of giving the premedication

Secondary

MeasureTime frame
Intraoperative ease of mask acceptance.Timepoint: After 30 mins of giving the premedication at the time of induction

Countries

India

Contacts

Public ContactDr Amanjot Singh

Baba Farid University of Health Sciences

amanjotrajpal@ggsmch.org9041221142

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026