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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

The Comparison of different dosage of Ketofol for Procedural Sedation and Analgesia in the Emergency Department :a Randomized,Prospective,Double-Blind Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015111825121N1
Enrollment
256
Registered
2016-04-30
Start date
2015-12-15
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention 1: Group A: A single dose of Propofol , 1 mg/kg ,IV as well as Ketamine 1 mg/kg , IV, 3 minute before the procedure .The next doses will be administered with half dose, or other sedative
Treatment - Drugs
Group A: A single dose of Propofol , 1 mg/kg ,IV as well as Ketamine 1 mg/kg , IV, 3 minute before the procedure .The next doses will be administered with half dose, or other sedative drugs ,if needed
Group B: A single dose of Propofol , 1 mg/kg ,IV, plus Ketamine 0.5 mg/kg ,IV , 3 minute before the procedure.The next doses will be administered with half dose ,or other sedative drugs,if needed.
Group C: A single dose of Propofol, 1 mg/kg , IV , plus Ketamine 0.33 mg/kg ,IV , 3 minutes before the procedure.The next doses will be administered with half dose or other sedative drugs,if needed.
Group G: A single dose of Propofol , 1 mg/kg , IV, plus Ketamine , 0.25 mg/kg , IV, 3 minute before the procedure.The next doses will be administered with half dose,or other sedative drugs,if needed.

Sponsors

Vice chancellor for research, Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Saeed Abbasi

Iran University of Medical Sciences

saeedabbasi@yahoo.com+98 21 6435 2197

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026