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IRCT2013111115379N1 IRCT 2015-06-08 Vice chancellor of Research, Shiraz University of Medical Sciences Reducing postoperative pain in addict patients with haloperidol Comparison of the effect of morphine versus morphine/haloperidol on postoperative pain management in opioid addicted patients undergoing orthopedic surgery 2008-06-22 anticipated Complete https://irct.ir/trial/14653 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization was done with sequential simple sampling method. Patients with odd and even file numbers were considered as haloperidol and placebo groups, respectively. The study was double-blinded, placebo controlled, randomized trial. The patients, the nurse giving the medications and the researcher filling the forms were all blind to the study groups. The medications were prepared by a staff not involved in the study. Fifty one syringes, labeled "A", were filled with 4 cc haloperidol (20 mg) while Fifty syringes, labeled "B", were filled with 4 cc normal saline. In the first episode of pain in the recovery unit, patients with odd file numbers received syringe "A" and those with even file numbers received syringe "B. The study was double-blinded, placebo controlled, randomized trial. The patients, the nurse giving the medications and the researcher filling the forms were all blind to the study groups. The medications were prepared by a staff not involved in the study. Fifty syringes, labeled "A", were filled with 4 cc normal saline while Fifty one syringes, labeled "B", were filled with 4 cc haloperidol (20 mg). In the first episode of pain in the recovery unit, patients with odd file numbers received syringe "A" and those with even file numbers received syringe "B". 3 Postoperative pain. Intervention 1: Intervention group: Morphine 0.1 mg/kg plus 20 mg haloperidol, just in the first episode of pain post operation, all intravenously. Intervention 2: Control group: Morphine 0.1 mg/kg plus 4cc normal saline, just in the first episode of pain postoperation, all intravenously.
public Asif P‍‍‍ervez Kazemi
Rajai Hospital, Chamran Blvd.
Shiraz Iran (Islamic Republic of) +98 71 3636 4001 ap_kazemi@yahoo.com Rajai Hospital scientific Asif Pervez Kazemi
Rajai Hospital, Chamran Blvd.
Shiraz Iran (Islamic Republic of) +98 71 3636 4001 ap_kazemi@yahoo.com Rajai Hospital Iran (Islamic Republic of) Inclusion criteria: Opium addict, male patients, between 20 to 50 years old, undergoing fixation of femoral or tibial fractures, according to the ranking system of American Society of Anesthesiologist (ASA) with physical state class I and II Exclusion criteria: Patients with psychological disorder or using any related medications, renal and hepatic disorder, benign prostate hyperplasia, glaucoma, and a history of reaction to haloperidol or extra pyramidal syndrome 20 years 50 years Male G89.18, T8 Other acute postprocedural pain; Other complications of procedures, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Morphine 0.1 mg/kg plus 20 mg haloperidol, just in the first episode of pain post operation, all intravenously Control group: Morphine 0.1 mg/kg plus 4cc normal saline, just in the first episode of pain postoperation, all intravenously Pain score. Timepoint: First episode of pain in recovery unit, 30 minute later, 1 hour later, 1.5 hour later and 2 hour later. Method of measurement: Categorical Scaling Form. Total morphine dose consumption. Timepoint: In each episode of pain in recovery unit injected morphine dose is recorded in milligram. Method of measurement: Summation of injected morphine doses in recovery unit. Vice chancellor of Research, Shiraz University of Medical Sciences Approved 2008-05-17 Ethics Committee of Shiraz University of Medical Science Shiraz University of Medical Sciences, Zand St. Shiraz Iran (Islamic Republic of)