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Intranasal Midazolam vs Ketamine-Midazolam for PRAEs in Pediatric Tonsillectomy
NCT06122948Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2023
- Primary completion
- Oct 2024
- Countries
- 1
- Sponsor
- Kasr Al Ainy Hospital
- Modality
- Small Molecules
- Drugs
- ketamine
01
Overview
Phase 3, randomised, double-blind trial of ketamine (2 arms), sponsored by Kasr Al Ainy Hospital. Primary endpoint: Incidence of Perioperative Respiratory Adverse Events at 8 hours. Started Nov 2023; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Midazolam Alone
Intranasal midazolam (0.1 mg/kg)
Midazolam + Ketamine
Intranasal midazolam (0.1 mg/kg) + ketamine (3 mg/kg)
03
Who it enrols
Children aged 3-12 years undergoing elective tonsillectomy and adenoidectomy (AT) with ASA grade I or II. Excludes children with congenital heart diseases, airway syndromes (e.g., Pierre-Robin, Down syndrome), severe lung diseases, recent upper respiratory tract infection, or neuromuscular diseases.
04
Endpoints
Primary
Incidence of Perioperative Respiratory Adverse Events
Secondary
Postoperative Pain Score
Sedation Success Rate
Postoperative Emergence Delirium
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