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The Comparison of different dosage of ketamine - propofol ( ketofol ) for Procedural Sedation and Analgesia for Orthopedic injuries in Rasoul-Akram ,Hafte-Tir and Firouzgar Emergency Department:a Randomized,Prospective,Double-Blind Trial

Phase 2
Conditions
Condition 1: Dislocation of shoulder joint. Condition 2: Dislocation of elbow. Condition 3: Dislocation of ankle joint. Condition 4: Dislocation of hip. Condition 5: Multiple fracture of femor. Condition 6: Multiple fracture of lower leg. Condition 7: Multiple fracture of forearm.
Dislocation of shoulder joint
Dislocation of elbow
Dislocation of ankle joint
Dislocation of hip
Multiple fracture of femor
Multiple fracture of lower leg
Multiple fracture of forearm
Registration Number
IRCT2015111825121N1
Lead Sponsor
Vice chancellor for research, Iran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
256
Inclusion Criteria

Patient should be candidate for procedural sedation in ED;Patient should be in age range of 14 and 65 years;Patient should be with of 1 or 2 in physical status in American society anesthesiologist classification.
Exclusion criteria : Pregnancy;Patients who have history of cardiovascular disease; Moderate to severe asthma attack; Present Pneumonia; Uncontrolled diabetes mellitus; Sepsis; Neurologic /Psychiatric disease:Using neurologic /psychiatric drugs; Moderate to severe obesity; cardiac; renal; liver; pulmonary insufficiency; Allergy to ketamine; propofol; soya; egg; Multiple trauma; Patients that do not fill consent form.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of Pain. Timepoint: Before and after procedure. Method of measurement: Visual analog scale.;Recovery time. Timepoint: From last drug prescription up to get needed criteria to leave the recovery. Method of measurement: Base on minute.;Sedation time. Timepoint: ?From first dose drug prescription up to get needed criteria to leave the recovery. Method of measurement: Base on minute.
Secondary Outcome Measures
NameTimeMethod
Blood pressure. Timepoint: Before and during of procedure,during recovery and complete conscious time. Method of measurement: Checking blood pressure (non invasive).;Heart rate. Timepoint: Before and during of procedure,during recovery and complete conscious time. Method of measurement: Checking the pulse for one minute.;Respiratory rate. Timepoint: Before and during of procedure,during recovery and complete conscious time. Method of measurement: Checking the RR for one minute.;Arterial oxygen saturation. Timepoint: Before and during of procedure,during recovery and complete conscious time. Method of measurement: Pulse oximetry monitoring.;Side effects of prescribed drugs. Timepoint: Before,during and after procedure. Method of measurement: Observation.;Patient's satisfaction. Timepoint: After procedure. Method of measurement: Base on Likert scale.;Practitioner's satisfaction. Timepoint: After procedure. Method of measurement: Base on Likert scale.
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