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Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department.
Sponsor: Sultan Qaboos University
Summary
This randomized controlled trial will compare two medication combinations, ketamine-dexmedetomidine (Ketadex) and ketamine-propofol (Ketofol), for procedural sedation in adults undergoing painful procedures in the emergency department. The primary objective is to compare the respiratory safety of the two sedation regimens, particularly the occurrence of hypoxic events and the need for airway interventions. Participants will be randomly assigned to receive either Ketadex or Ketofol. The study will also compare recovery time, hemodynamic effects, pain, emergence reactions, nausea and vomiting, and other adverse events between the two groups. The study will be conducted in the Emergency Department at Sultan Qaboos University Hospital, University Medical City, Oman.
Official title: Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10-10
Completion Date
2029-03-01
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Ketamine (1 mg/kg)
Ketamine 1 mg/kg will be administered intravenously as a bolus. In the Ketofol arm, ketamine will be mixed with propofol 1 mg/kg in the same syringe. In the Ketadex arm, ketamine 1 mg/kg will be administered without propofol in the bolus syringe. The bolus syringe will be covered with an opaque white label to maintain blinding.
propofol
Propofol 1 mg/kg will be mixed with ketamine 1 mg/kg in the same syringe and administered as an intravenous bolus to participants assigned to the Ketofol arm. The syringe will be covered with an opaque white label to maintain blinding.
Dexmedetomidine
Dexmedetomidine 1 microgram/kg will be administered intravenously over 10 minutes using an infusion pump or syringe driver to participants assigned to the Ketadex arm.
Normal Saline
Normal saline, 15 mL, will be administered intravenously over 10 minutes using an infusion pump or syringe driver to participants assigned to the Ketofol arm. It will serve as the placebo infusion in the double-dummy design.
Locations (1)
Sultan Qaboos University Hospital- UMC
Seeb, Muḩāfaz̧at Masqaţ, Oman