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A study to compare the effects of two drugs melatonin and midazolam given before surgery on behaviour after emerging from inhalation anaesthesia in children.

Comparison of effect of preoperative melatonin versus midazolam on emergence delirium in children: a double blind randomized placebo controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019850
Enrollment
135
Registered
2019-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Preoperative medication with melatonin.: Preoperative medication with melatonin at a dose of 0.3mg/kg 45 min orally before elective ambulatory daycare surgical procedures in children.

Sponsors

Department Of Anaesthesia and Intensive Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status category 1 or 2 children scheduled for elective ambulatory daycare surgical procedures within 3 hours, to be performed under general anaesthesia.

Exclusion criteria

Exclusion criteria: ASA 3 or more physical status children less than 3 years or more than 8 years undergoing other than elective ambulatory daycare surgical procedures or procedures lasting for more than 3 hours with any evidence of neurological disease, neurodevelopmental anomalies, mental retardation , visually or hearing impairment.

Design outcomes

Primary

MeasureTime frame
Incidence of emergence delirium in children .Timepoint: After end of anaesthesia for 30 minutes.

Secondary

MeasureTime frame
Induction compliance checklist.Timepoint: At induction of anaesthesia.;Perioperative anxiety.Timepoint: Before induction of anaesthesia.

Countries

India

Contacts

Public ContactDr Preethy J Mathew

PGIMER

tjpreethy@gmail.com7087009530

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026