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Comparison of presence of parents with oral midazolam premedication for reducing preoperative anxiety in children undergoing elective surgery under general anaesthesia.

Comparison of parental presence with oral midazolam premedication for reducing preoperative anxiety in children undergoing elective surgery under general anaesthesia. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093526
Enrollment
80
Registered
2025-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Oral Midazolam: Midazolam group (Group M), the child will be premedicated with 0.5 mg/kg oral midazolam mixed in honey. The parent will stay with the child in the preoperative room for

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.American Society of Anaesthesiologists [ASA] physical status I and II patients. 2. AGE: 2-8yrs. 3. Elective surgical procedure

Exclusion criteria

Exclusion criteria: 1. Difficult airway 2. Mental or physical disabilities 3. Treatment with sedatives or anticonvulsant

Design outcomes

Primary

MeasureTime frame
Anxiety score measured by Modified Yale preoperative anxiety scale Score (mYPAS) Timepoint: mYPAS will be measured at 3 points : 1.just before shifting to OT 2.placing patient on OT table 3.On introduction of face mask during induction of anaesthesia.

Secondary

MeasureTime frame
Face Mask acceptance score by Mask acceptance scale (MAS) Hemodynamic parameters (HR, SpO2) in both groups Timepoint: 1.Hemodynamic parameters will be recorded from the time of bringing the child in the preoperative room & then every 10 minutes till the time of putting the child on the operating table & placing the face mask for induction. 2.Face mask will be applied at the start of induction of anaesthesia. Mask acceptance score will be assessed by an independent observer using a 3 point Mask Acceptance Score

Countries

India

Contacts

Public ContactNamita Arora

ABVIMS AND DR RML HOSPITAL NEW DELHI-110001

drnamitaarora@gmail.com9868219619

Outcome results

None listed

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