Ketofol versus midazolam/fentanyl for Procedural Sedation and Analgesia in the Emergency Department: a Randomized, Prospective, Double-Blind Trial
Not Applicable
- Conditions
- orthopedic procedures in the ED.
- Registration Number
- IRCT201009204784N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
patients requiring PSA for mainly orthopedic procedures in the ED
Exclusion criteria: American Society of Anesthesia (ASA) physical status = 3; a history of adverse reaction to Ketamine, Propofol, Midazolam, Fentanyl or egg; pregnancy; increased intracranial pressure; multiple trauma and psychiatric diseases
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sedation. Timepoint: before and after procedure. Method of measurement: Ramsay Sedation Score.;Severity of Pain. Timepoint: before and after procedure. Method of measurement: VAS.
- Secondary Outcome Measures
Name Time Method Blood pressure. Timepoint: before and after procedure. Method of measurement: checking blood pressure (non invasive).;Practitioner’s satisfaction. Timepoint: after the procedure. Method of measurement: Physician’s satisfaction ratings were recorded on a Visual Analog Scale (VAS), with 0= very unsatisfied” and 10 = completely satisfied”. Pain intensity was assessed by using a 10-cm VAS, with 0 = no pain” and 10 = worst possible pain.”.;Arterial oxygen saturation. Timepoint: before and after procedure. Method of measurement: pulse oximetry monitoring.;Heart rate. Timepoint: before and after procedure. Method of measurement: checking the pulse for one minute.;Side effects of prescribed drugs. Timepoint: before, during and after procedure. Method of measurement: observation.