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IRCT20160802029162N2 IRCT 2017-12-20 Ardabil University of Medical Sciences Efficacy of morphine and buprenorphine in post-operative pain Comparison the efficacy of morphine and sublingual buprenorphine in decreasing postoperative pain in orthopedic surgery of the lower limbs 2016-09-20 anticipated 60 Complete https://irct.ir/trial/28260 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients were allocated randomly to one of the two groups using a computer-generated random number table and sealed envelope technique, Blinding description: Patients in the morphine group received morphine PCA pump and placebo tablets (similar to buprenorphine pills) and patients in the buprenorphine group received buprenorphine tablets and placebo PCA pump (normal saline). The patients and the nurse prescribing the drugs were not aware of the contents of the pumps and tablets. N/A Fractures in lower limbs. Intervention 1: Intervention group 1: Patients in this group received 20 mg morphine by PCA pump and placebo tablets (similar to buprenorphine pills). Intervention 2: Intervention group 2: Patients in this group received buprenorphine tablets and placebo PCA pump (normal saline). No - There is not a plan to make this available Justification or reason for not sharing IPD is All publishing rights are reserved to Ardabil University of Medical Sciences
public Saba Esmaeeli
Imam Khomeini hospital , Ataee St, Ardabil
Ardabil Iran (Islamic Republic of) 56189-85991 +98 45 3325 1401 SabaEsmaeelimed@gmail.com Ardabil University of Medical Sciences scientific Dr. Ghodrat Akhavan Akbari
Fatemi hospital, Imam Khomeini st., Ardabil
Ardabil Iran (Islamic Republic of) 5614733775 +98 45 3323 4682 g.akbari@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Lower Limb Orthopedic Surgery ASA class I or II age between 20 and 60 years old 20 years 60 years Both Previous hypersensitivity to Buprenorphine Previous hypersensitivity to Morphine History of analgesic use in the past 24 hours Pregnant and lactating women Addiction to Narcotic or Alcohol or Benzodiazepines T025 Fractures involving multiple regions of both lower limbs Prevention Prevention Intervention group 1: Patients in this group received 20 mg morphine by PCA pump and placebo tablets (similar to buprenorphine pills). Intervention group 2: Patients in this group received buprenorphine tablets and placebo PCA pump (normal saline). Postoperative pain. Timepoint: at 1, 8, 16, and 24 hours after surgery. Method of measurement: Visual Analogue Scale. Nausea. Timepoint: at 1, 8, 16, and 24 hours after surgery. Method of measurement: N/V Score. Vomiting. Timepoint: at 1, 8, 16, and 24 hours after surgery. Method of measurement: N/V Score. Itching. Timepoint: at 1, 8, 16, and 24 hours after surgery. Method of measurement: asking the patient. Ardabil University of Medical Sciences Approved 2016-12-11 Ethics committee of Ardabil University of Medical Sciences Daneshgah st. Ardabil Complex University. Ardabil Ardabil Iran (Islamic Republic of)