Health Condition 1: J40-J47- Chronic lower respiratory diseases Health Condition 2: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Intravenous Midazolam: Intravenous Midazolam [0.1-0.2mg/kg] administered as a slow bolus over 1 min
Control Intervention1: Intravenous Promethazine-Pentazocine: intravenous Promethazine
Sponsors
Lady Hardinge Medical College and Kalawati Saran Childrens Hospital, New Delhi.
Eligibility
Inclusion criteria
Inclusion criteria: All children, 6 months-18 years of age, requiring procedural sedation for flexible bronchoscopy.
Exclusion criteria
Exclusion criteria: 1. Cardiovascular instability 2. Oxygen saturation 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Modified Physician-reported feasibility score at end of procedure. Hemodynamic changes during bronchoscopy. Proportion of children who require additional sedation. Number of desaturation events. Time taken to recover from sedation.(Ramsay Sedation Score more than or equal to 3 to RSS 1) Timepoint: During and at end of procedure. for recovery time- at 30mins, 60mins and 90 mins after procedure. | — |
Countries
India
Contacts
Public ContactDivya Baweja
Lady Hardinge Medical College and Kalawati Saran Childrens Hospital
Outcome results
None listed