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Comparison between sedative medication combinations Fentanyl -Ketamine and Midazolam -Ketamine for use in sedation in children during flexible bronchoscopy

Fentanyl- Ketamine versus Midazolam-Ketamine for sedation in children undergoing flexible fiber-optic bronchoscopy -An open label Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052577
Enrollment
65
Registered
2023-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Fentanyl -Ketamine for sedation in children undergoing flexible fiberoptic bronchoscopy: Ketamine at dose of 1mg/kg intravenous and fentanyl at dose of 1mcg/kg intravenous and additiona

Sponsors

All India Institute of Medical Sciences BHUBANESWAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged 6 months to 15 years admitted for flexible bronchoscopy in department of Pediatrics, AIIMS Bhubaneswar

Exclusion criteria

Exclusion criteria: 1. Children with difficult airway 2. Children with hemodynamic compromise requiring vasoactive inotropic score >10 3. Children on respiratory support requiring FiO2 >40% or high flow nasal cannula therapy 4. Children who require therapeutic procedures using flexible bronchoscopy like endobronchial biopsy, stent placement, balloon dilatation, foreign body removal

Design outcomes

Primary

MeasureTime frame
Number of severe cough episodes during bronchoscopy in either groupTimepoint: Time starting from the administration of sedative medications upto 20 minutes of bronchoscopy

Secondary

MeasureTime frame
1.The time to achieve Ramsay sedation score 4 after administration of medication 2.Adverse effects of medications like hypotension,hypertension,bradycardia,tachycardia,hypoxemia 3.Bronchoscopy score Timepoint: 1.Time to achieve Ramsay sedation score 4 from the point of administration of sedatives 2.Vitals like heart rate,respiratory rate, Blood pressure,SpO2 5 minutes before administration of sedatives (baseline) then every 5 minutes during and after bronchoscopy for 1 hour 3.Bronchoscopy score is recorded from administration of sedative medications till completion of bronchoscopy

Countries

India

Contacts

Public ContactDr Gopika Ramesh

All India Institute of Medical Sciences,Bhubaneswar

ped_krishna@aiimsbhubaneswar.edu.in9582273062

Outcome results

None listed

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