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Oral Melatonin vs Midazolam for Emergence Delirium in Pediatric Anesthesia: A Randomized Study

A prospective randomized study to know the effect of premedication with oral melatonin vs oral midazolam on emergence delirium in children undergoing general anesthesia - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082307
Enrollment
110
Registered
2025-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: K353- Acute appendicitis with localizedperitonitis Health Condition 2: N10- Acute pyelonephritis Health Condition 3: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 4: H712- Cholesteatoma of mastoid Health Condition 5: H044- Chronic inflammation of lacrimal passages Health Condition 6: H701- Chronic mastoiditis Health Condition 7: M864- Chronic osteomyelitis with draining sinus Health Condition 8: Q544- Congenital chordee Health Condition 9: N

Interventions

Intervention1: Group-A: Oral Melatonin : Approximately 30-40 minutes prior to induction of anesthesia, single dose of oral premedication will be given to patients in Group A (Melatonin 0.5mg/kg) by

Sponsors

North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing general anaesthesia. ASA physical status I &II

Exclusion criteria

Exclusion criteria: Patientâ??s parent refusal Patient with known allergy to the drugs used in the study Hemodynamic instability. Patients with significant cardiac, respiratory and hepatic dysfunction • Patients with history of agitation or on melatonin or midazolam

Design outcomes

Primary

MeasureTime frame
To compare the anxiety levels preoperatively and emergence delirium postoperatively Timepoint: Preoperative and postoperative 2hrs

Secondary

MeasureTime frame
To compare the intraoperative hemodynamic changes, incidence of complications, parentâ??s anxiety level Timepoint: Intraoperative

Countries

India

Contacts

Public ContactDr Priyanka Dev

North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS)

priyanka8ap@gmail.com7577055859

Outcome results

None listed

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