Melatonin vs Midazolam in Children Undergoing Tonsillectomy

Effect of Oral Melatonin versus Oral Midazolam as a Premedication in Children Undergoing Tonsillectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202512498704309

Enrollment

192

Registered

2025-12-05

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Paediatrics Anaesthesia

Interventions

Control Group

Melatonin group

Midazolam group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ALL children with ASA class I and class II

Exclusion criteria

Exclusion criteria: Chest infection Abnormal mental milestones. Children with any organ dysfunction. Allergies to any of the drugs used. Children with Obstructive sleep apnea.

Design outcomes

Primary

Measure	Time frame
Incidence of preoperative anxiety with oral melatonin vs oral midazolam as a premedication in Children Undergoing Tonsillectomy. Description: Assessment of sedation and anxiolysis 30 minutes after the drug administration using Ramsay sedation scale.	—

Secondary

Measure	Time frame
Effect of both drugs in reducing incidence of post operative emergence delerium Description: Pediatric Anesthesia Emergence Delirium (PAED) Scale Score. The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable score is 20. A score of =10 has 64% sensitivity and 86% specificity for the diagnosis of ED. A score of >12 has 100% sensitivity and 94.5% specificity for the diagnosis of ED	—

Measure

Time frame

Effect of both drugs in reducing incidence of post operative emergence delerium Description: Pediatric Anesthesia Emergence Delirium (PAED) Scale Score. The PAED scale consists of 5 criteria that are scored using a 5-point scale. The scores of each criterion are added to make a total score. The maximum achievable score is 20. A score of =10 has 64% sensitivity and 86% specificity for the diagnosis of ED. A score of >12 has 100% sensitivity and 94.5% specificity for the diagnosis of ED

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Countries

Egypt

Contacts

Public Contactalaa zorkany

professor

alaa.zorkany@med.asu.edu.eg00201115811666

Outcome results

None listed

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