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IRCT201204089387N2 IRCT 2013-03-26 Vice Chancellor for Research, Tehran University of Medical Sciences Comparing the efficacy of morphine sulfate and oxycodone in pain management Comparing the efficacy and adverse effects of oxycodone and morphine sulfate in isolated limb trauma patients, admitted to emergency department of Imam Khomeini hospital, between 2011 and 2012 period 2012-08-19 anticipated 40 Complete https://irct.ir/trial/9916 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 3 Acute lower limb injury. Intervention 1: Oxycodone hydrochloride; manufactured by SOHA company; 5 milligrams single dose; oral; in intervention group. Intervention 2: Placebo (distilled water); manufactured in Daroupakhsh; single dose; intravenous injection; in intervention group. Intervention 3: Morphine sulfate; manufactured in Daroupakhsh; 5 milligrams single dose; intravenous injection; in control group. Intervention 4: Placebo; manufactured by SOHA company; single dose; oral; in control group.
public Mohammad Jalili
Room 107, 7th Floor, TUMS Central Building, Ghods St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) +98 21 6641 8595 mjalili@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Jalili
Room 701, 7th Floor, TUMS Central Building, Ghods St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) +98 21 6641 8595 mjalili@tums.ac.ir Emergency Department of Imam Khomeini hospital Iran (Islamic Republic of) Inclusion criteria: acute lower limb trauma Exclusion criteria: Patients younger than 14 or older than 90 years old, recent use of opioid, advanced liver/respiratory/renal diseases, head trauma, altered mental state, allergy to opioid, pregnancy 14 years 90 years Both s70, s72, Superficial injury of hip and thigh, Fracture of femur, Dislocation, sprain and strain of joint and ligaments of hip, Injury of muscle and tendon at hip and thigh level, Crushing injury of hip and thigh, Traumatic amputation of hip and thigh, Superficial Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Oxycodone hydrochloride; manufactured by SOHA company; 5 milligrams single dose; oral; in intervention group Placebo (distilled water); manufactured in Daroupakhsh; single dose; intravenous injection; in intervention group Morphine sulfate; manufactured in Daroupakhsh; 5 milligrams single dose; intravenous injection; in control group Placebo; manufactured by SOHA company; single dose; oral; in control group Pain severity. Timepoint: 0, 30 and 60 minutes after administration of analgesic. Method of measurement: asking patients, using NRS score. Side effects. Timepoint: 0, 30 and 60 minute after administration of analgesic. Method of measurement: asking patient, using questionnaire. Blood pressure. Timepoint: Zero, 30, and 60 minutes after administration of analgesic. Method of measurement: Checking blood pressure, using appropriate cuff. Nausea and vomiting. Timepoint: Zero, 30 and 60 minutes after administration of analgesic. Method of measurement: Asking patient, using questionnaire. Drowsiness. Timepoint: Zero, 30 and 60 minutes after administration of analgesic. Method of measurement: Asking patient, using questionnaire. Vice Chancellor for Research, Tehran University of Medical Sciences Approved 2012-05-23 ETHICS COMMITTEE OF TEHRAN UNIVERSITY OF MEDICAL SICIENCE KESHAVARZ BLVD, CENTRAL BULDING OF TEHRAN UNIVERSITY OF MEDICAL SICIENCE TEHRAN Iran (Islamic Republic of)