Comparison of Ketofol with Ketamine for procedural sedation and analgesia in emergency department

Phase 3

• Conditions: Condition 1: Dislocation of elbow. Condition 2: Dislocation of shoulder joint. Condition 3: Dislocation of radial head. Condition 4: Dislocation of wrist. Condition 5: Dislocation of toe(s). Condition 6: laceration repair. Condition 7: Dislocation of ankle joint. Condition 8: removal of pins. Condition 9: repair of open wound of finger with damage to nail.; Dislocation of elbow; Dislocation of shoulder joint; Dislocation of wrist; Follow-up care involving removal of fracture plate and other internal fixation device; Open wound of finger(s) with damage to nail; Dislocation of radial head; Dislocation of toe(s); Dislocation of ankle joint

• Registration Number: IRCT2014053117927N1
• Lead Sponsor: Vice chancellor for research, Aja university of medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patient should be Candidate for Procedural sedation and analgesia in emergency department (complicated laceration repair, abscess incision and drainage, closed joint reduction); Adult patient (should be in age range of 18 and more and 60 and less); Patient should be with score of 1 or 2 in physical status in American society of anesthesiologist classification; If it is not the urgency procedures patient should be fasting at least for 3 hours; Any other drugs except the study drugs (such as opioids or sedatives) shouldn't be prescribed to the patient prior to the study; Patient shouldn't have the Known allergy to Ketamine or any component of the formulation; Patient shouldn't have the Known allergy to Propofol or any component of the formulation (Egg and Soya); Patient shouldn't suffer from the illnesses which have high Intracranial pressure or the illnesses which having high Intracranial pressure is dangerous, such as (intracranial tumor, subdural hematoma, Head injury, Hydrocephalus ); Patient shouldn't suffer from the open eye injuries and eye diseases ( glaucoma, etc) in which the intraocular pressure is dangerous; Patient shouldn't suffer from Known aneurysm; Patient shouldn't have the history of co-existing psychotic disease such as schizophrenia and epilepsia; Patient shouldn't be pregnant.
Exclusion criteria
The patient or his attendant don't sign printed informed consent form.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ausea and/or vomiting. Timepoint: From drug prescription up to get needed criteria to leave the recovery. Method of measurement: The frequency of nausea and/or vomiting; record in questionnaire.;Procedural agitation. Timepoint: During the procedure to just before starting the recovery. Method of measurement: Base on physician’s judge; Patient interferes with the procedure or/and shows unusual reactions to painful manipulation despite enough doses of drug; record in questionnaire.;Recovery agitation. Timepoint: From the beginning of recovery to get required criteria to leave the recovery. Method of measurement: Base on physician’s judge; excessive excitement, arousal and agitation in the form of crying, hallucinations can be seen; record in questionnaire.;Respiratory adverse events. Timepoint: From drug prescription up to get needed criteria to leave the recovery. Method of measurement: Based on Quebec criteria; record in questionnaire.