Study on preoperative sedation in pediatric surgery.

Comparison Of Oral Premedication In Children With Midazolam, Dexmedetomidine And Melatonin For Ease Of Separation From Parents Before Anesthesia : A Randomized Controlled Study - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081317

Enrollment

Registered

2025-02-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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: Oral Dexmedetomidine: 2.5mcg/Kg In Children Undergoing Surgery Per Orally Single Dose Stat 60 Mins Before Surgery. Intervention2: Oral Melatonin: 0.5mg/Kg In Children Undergoing Surgery

Eligibility

Inclusion criteria

Inclusion criteria: Children aged between 2 to 6 years. Undergoing Elective surgery. Children Assessed under ASA I ,II.

Exclusion criteria

Exclusion criteria: Children with difficult airway. Children with intellectual Disability . ADHD and other psychiatric / Sleep disorders. Children with pre existing liver ,Renal ,Heart problems. Children whose parents/Guardians are not willing for the consent and the study.

Design outcomes

Primary

Measure	Time frame
Ease Of Separation From Parents By A Scale Timepoint: 60 Mins After Drug Adminstration	—

Secondary

Measure	Time frame
Preoperative Anxiety By Modified Yale ScaleTimepoint: 60 Mins After Drug Adminstration;Sedation By Observer Sedation ScoreTimepoint: 60 Mins After Drug Adminstration;Mask Acceptance By Mask Acceptance ScoreTimepoint: 60 Mins After Drug Adminstration;HemodynamicsTimepoint: Perioperatively Every 15 Mins Once And Continued Till 1hour Post Opertaive	—

Countries

India

Contacts

Public ContactSaravanan C R

srm medical college

drcrsaravanan@gmail.com9884001153

Outcome results

None listed

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