A Study to compare Pentazocine-Promethazine and Midazolam for sedation in pediatric flexible bronchoscopy
Not Applicable
- 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
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.