A Study to compare Pentazocine-Promethazine and Midazolam for sedation in pediatric flexible bronchoscopy

Not Applicable

Recruiting

• Conditions: Health Condition 1: J40-J47- Chronic lower respiratory diseasesHealth Condition 2: J00-J99- Diseases of the respiratory system

• Registration Number: CTRI/2023/01/049036
• Lead Sponsor: ady Hardinge Medical College and Kalawati Saran Childrens Hospital, New Delhi.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All children, 6 months-18 years of age, requiring procedural sedation for flexible bronchoscopy.

Exclusion Criteria

1. Cardiovascular instability

2. Oxygen saturation <90% at the time of enrolment

3. Encephalopathy or impaired consciousness

4. Children who are already on any sedative medication, or any intervention which would interfere with outcome, and contraindications to use these medications

5. Previous untoward reaction for medications used for sedation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of children who achieve Ramsay Sedation Score 3 within 5 minutes of administration of control or intervention drug.Timepoint: within 5 minutes of administration of control or intervention drug.

Secondary Outcome Measures

Name	Time	Method
Modified Physician-reported feasibility score at end of procedure. <br/ ><br>Hemodynamic changes during bronchoscopy. <br/ ><br>Proportion of children who require additional sedation. <br/ ><br>Number of desaturation events. <br/ ><br>Time taken to recover from sedation.(Ramsay Sedation Score more than or equal to 3 to RSS 1) <br/ ><br>Timepoint: During and at end of procedure. <br/ ><br>for recovery time- at 30mins, 60mins and 90 mins after procedure.