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IRCT2014053117927N1 IRCT 2015-06-29 Vice chancellor for research, Aja university of medical sciences Comparison of Ketofol with Ketamine for procedural sedation and analgesia in emergency department - Comparison of efficacy and adverse events of ketamine-propofol(ketofol) with ketamine alone for procedural sedation and analgesia in emergency department 2014-04-21 anticipated 80 Complete https://irct.ir/trial/16375 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: simple random sampling (the first patient in the control group, the second patient in the intervention group, the third patient in the control group and so on until the last patient). 3 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. Intervention 1: Intervention group: First the concentration of Ketamine(produce by hameln pharmaceuticals gmbh) should be diluted to 10 milligram per milliliter and then combine 5 milliliter of that with 5 milliliter of Propofol ( 10 milligram per milliliter produced by B Braun company) in a syringe. Sedation should start with an initial dose of .075 milliliter per kilogram Ketofol (0.375 milligram per kilogram Ketamine, 0.375 milligram per kilogram Propofol) in 30 seconds. One minute after the initial dose and per minute subsequent after that patient's level of sedation be measured according to Ramsay sedation scale. When the Ramsay sedation levels 5 or 6 achieve, the procedure will begins. If the physician diagnoses the sedation level is not properly (less than 5 Ramsay score) 0.0375 milliliter per kilogram ketofol (0.188 milligram per kilogram of either Ketamine and propofol ) is prescribed and after a minute procedure will begins if the sedation level is proper. Information will record in questionnaire. Intervention 2: Control group : First the concentration of Ketamine(hameln pharmaceuticals GmbH) should be diluted to 10 milligram per milliliter. sedation is prescribed with initial dose of 0.075 milliliter per kilogram Ketamine(0.75 milligram per kilogram) in 30 seconds. One minute after the initial dose and per minute subsequent after that patient's level of sedation is measured according to Ramsay sedation scale. When the Ramsay sedation levels 5 or 6 achieve ,the procedure will begins. If the physician diagnoses the sedation level is not properly (less than 5 Ramsay score) 0.0375 milliliter per kilogram Ketamine(0.375 milligram per kilogram) is prescribed and after a minute procedure will begins if the sedation level is proper. Information will record in questionnaire.
public Javad Hajizadeh Reineh
Iran University of medical sciences Campus, Hemmat freeway, next to Milad tower
Tehran Iran (Islamic Republic of) +98 21 8862 2750 javadhajizadeh67@gmail.com Iran university of medical sciences scientific Javad Hajizadeh Reineh
Iran University of medical sciences Campus, Hemmat freeway, next to Milad tower
Tehran Iran (Islamic Republic of) +98 21 8862 2750 javadhajizadeh67@gmail.com Iran university of medical sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years 60 years Both S53.1 S43.0 S53.0 S63.0 S93.1 S93.0 Z47.0 S61.1 Dislocation of elbow Dislocation of shoulder joint Dislocation of radial head Dislocation of wrist Dislocation of toe(s) Dislocation of ankle joint Follow-up care involving removal of fracture plate and other internal fixation device Open wound of finger(s) with damage to nail Treatment - Drugs Treatment - Drugs Intervention group: First the concentration of Ketamine(produce by hameln pharmaceuticals gmbh) should be diluted to 10 milligram per milliliter and then combine 5 milliliter of that with 5 milliliter of Propofol ( 10 milligram per milliliter produced by B Braun company) in a syringe. Sedation should start with an initial dose of .075 milliliter per kilogram Ketofol (0.375 milligram per kilogram Ketamine, 0.375 milligram per kilogram Propofol) in 30 seconds. One minute after the initial dose and per minute subsequent after that patient's level of sedation be measured according to Ramsay sedation scale. When the Ramsay sedation levels 5 or 6 achieve, the procedure will begins. If the physician diagnoses the sedation level is not properly (less than 5 Ramsay score) 0.0375 milliliter per kilogram ketofol (0.188 milligram per kilogram of either Ketamine and propofol ) is prescribed and after a minute procedure will begins if the sedation level is proper. Information will record in questionnaire. Control group : First the concentration of Ketamine(hameln pharmaceuticals GmbH) should be diluted to 10 milligram per milliliter. sedation is prescribed with initial dose of 0.075 milliliter per kilogram Ketamine(0.75 milligram per kilogram) in 30 seconds. One minute after the initial dose and per minute subsequent after that patient's level of sedation is measured according to Ramsay sedation scale. When the Ramsay sedation levels 5 or 6 achieve ,the procedure will begins. If the physician diagnoses the sedation level is not properly (less than 5 Ramsay score) 0.0375 milliliter per kilogram Ketamine(0.375 milligram per kilogram) is prescribed and after a minute procedure will begins if the sedation level is proper. Information will record in questionnaire. Nausea 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. Efficacy. Timepoint: From drug prescription up to end of the procedure. Method of measurement: Efficacy in this study is defined 1) recall the events during the procedure in unpleasant way 2) patient doesn't experience the adverse events which cause unfinished procedure, permanent complication or unplanned admission to hospital.3)patient doesn't resist actively against the procedure and record in questionnaire. Heartbeat rate. Timepoint: every minutes, 3 minutes before injection to achieve the required criterion for exiting the recovery. Method of measurement: Heartbeat rate in per minute shown by monitoring with the brand called Sa'adat; record in questionnaire. Blood pressure. Timepoint: 3 minutes before injection, a minute after injection and per 4 minutes after injection to achieve the required criterion for exiting the recovery. Method of measurement: amount of blood pressure Based on millimeters of mercury shown by monitoring with the brand called Sa'adat; record in questionnaire. The onset of medication to achieve adequate depth of sedation. Timepoint: The start of injection to achieve a Ramsay sedation score of 5 or more. Method of measurement: The duration of sedation score 5 or more is achieved. the sedation score should be announced per minute to end of the procedure; record in questionnaire. Recovery time. Timepoint: From last dose drug prescription up to get needed criteria to leave the recovery. Method of measurement: Base on Aldrete scale; minimum score of 8, with a minimum of 2 in respiratory and oxygen saturation; every minute; record in questionnaire. Muscular rigidity. Timepoint: From drug prescription up to end of the procedure. Method of measurement: Base on physician’s judge; record in questionnaire. Vice chancellor for research, Aja university of medical sciences Approved 2014-02-10 Ethics committee of Aja university of medical sciences Aja university of medical sciences, Shahid Etemadzadeh St, westerly shahid Fatemi St Tehran Iran (Islamic Republic of)