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IRCT20141209020258N146 IRCT 2020-07-10 Arak University of Medical Sciences The effect of addition of ketamine, lidocaine and ‎acetaminophen and dexmedetomidine to morphine in the pain control of opium addicts Comparison of the effect of addition of Ketamine, Lidocaine, Acetaminophen and Dexmedetomidine to morphine in the pain control of opium addicts after orthopedic surgery 2020-05-21 anticipated 140 Complete https://irct.ir/trial/48946 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with envelopes into 4 groups of A and B and C and D . In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were mixed. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are mixed again and we pulled out another card. This process continued to reach a random sequence ‎according to sample size, Blinding description: This study is double blind. Outcome evaluator and analyzer and participant are blind (double blind). Outcome evaluator and analyzer and participant don't aware from grouping. Drug sets will be covered with foil. After calculating the amount, the required drugs are drawn in 50 ML syringes and prescribed at the desired dose. 3 Pain after orthopedic surgery. Intervention 1: Intervention group 1: 1 mg/kg of Ketamine (produced by Rotex Medica company, Germany) will be added to morphine. Intervention 2: Intervention group 2: 15 mg/kg of Acetaminophen (produced by Coble Drug company, Iran) will be added to morphine. Intervention 3: Intervention group 3: 1.5 mg/kg of Lidocaine(produced by Caspian Tamin Rasht company-Iran) will be added to morphine. Intervention 4: Intervention group 4: 1 micro gram per kilogram of Dexmedetomidine (produced by Exir Company) will be added to morphine. Yes - There is a plan to make this available What will be shared: When we publish article in journal, the raw data file will be provided to researchers. When: After the article is published To whom: Researcher in university Conditions: If there are additional questions Where to obtain: Dr Hesamodin Modir How to obtain: They have to write letters to the professors and the university. Comments:
public Dr Esmaeel Moshiri
Valiasr hospital; Valiasr square; Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr hospital; Valiasr square; Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age of 20 to 60 years old ASA class 1 and 2 20 years 60 years Both Dissatisfaction with studying Not accepting spinal anesthesia as a method of anesthesia Obesity Chronic pain Mental disorders History of seizures Use psychotropic drugs Use of painkillers (more than a week) Sensitivity to drugs Upper respiratory infection Pregnancy Breastfeeding Existence of hemodynamic instability Z47.82 Encounter for orthopedic aftercare following scoliosis surgery Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: 1 mg/kg of Ketamine (produced by Rotex Medica company, Germany) will be added to morphine. Intervention group 2: 15 mg/kg of Acetaminophen (produced by Coble Drug company, Iran) will be added to morphine. Intervention group 3: 1.5 mg/kg of Lidocaine(produced by Caspian Tamin Rasht company-Iran) will be added to morphine. Intervention group 4: 1 micro gram per kilogram of Dexmedetomidine (produced by Exir Company) will be added to morphine. Relaxation. Timepoint: At 1, 6, 12 and 24 hours after connecting the pump. Method of measurement: Ramsy score. Average drug use. Timepoint: 24 hours after connecting the pump. Method of measurement: Observation. Nausea and vomiting. Timepoint: At 1, 6, 12 and 24 hours after connecting the pump. Method of measurement: Observation. Pain. Timepoint: At 1, 6, 12 and 24 hours after connecting the pump. Method of measurement: Visual pain analog scale. Arak University of Medical Sciences Approved 2020-05-10 Ethics comittee of Arak University of Medical Sciences Ethics comitte; Vice Chancellor for Research and Technology; Payambar Azam complex, Basij square; Sardasht Arak Markazi Iran (Islamic Republic of)