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IRCT20180130038568N1 IRCT 2018-02-15 Tehran University of Medical Sciences Evaluation of analgesic effect of Intravenous Ketamine and Intravenous Fentanyl in adult patients with acute pain, in Emergency Department, Sina Hospital Evaluation of analgesic effect of Intravenous sub dissociative ketamine and Intravenous fentanyl in adult patients with acute pain, in Emergency Department, Sina Hospital, 1395 - 1398 2016-03-20 anticipated 200 Complete https://irct.ir/trial/29333 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: with Block Stratified Randomization Windows version 6.0 software, Blinding description: with Block Stratified Randomization Windows version 6.0 software. The patient knows that he or she taking intravenous Ketamine or Fentanyl randomly. The researcher and the person that follows patients are not a same person. N/A Acute pain in Emergency Room. Intervention 1: Intervention group: Prescribing intravenous Ketamine in dose 0.3 mg per kg for adult patients in Emergency Room that suffering acute pain and the pain score is above 5/10. Intervention 2: Control group: Prescribing intravenous Fentanyl in dose 1 micro gram per kg for adult patients in Emergency Room that suffering acute pain and the pain score is above 5/10. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because of privacy of patients data
public Pooya Payandemehr
Hassan Abad Square, Sina Hospital, Emergency Department
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 pooya_mehr@yahoo.com Tehran University of Medical Sciences scientific Pooya Payandemehr
Hassan Abad Square, Sina Hospital, Emergency Department
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 pooya_mehr@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Any admitted adult patient in Emergency Room He or she has acute and sever pain The pain score is above 5/10 18 years no limit Both Pain score ≤ 5 Pregnancy and post-partum women Allergy to ketamine or fentanyl Body weight ≤ 46 kg or ≥ 115 Altered mental status Unstable vital signs: BP≤ 90 mmHg or ≥ 180 mmHg , PR≥150 or ≤50 bits/min , RR≤10 or ≥30 History of recent head or eye trauma History of Siesure History of elevated ICP Chronic pain Renal or hepatic failure Substance or alcohol abuse Documented psychiatric disorders Opium addiction Recent use of narcotic analgesics R52 Pain, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Prescribing intravenous Ketamine in dose 0.3 mg per kg for adult patients in Emergency Room that suffering acute pain and the pain score is above 5/10 Control group: Prescribing intravenous Fentanyl in dose 1 micro gram per kg for adult patients in Emergency Room that suffering acute pain and the pain score is above 5/10 Pain score. Timepoint: Minute 0, 5, 10, 15, 30. Method of measurement: Scoring 1 to 10. Tehran University of Medical Sciences Approved 2017-06-19 Ethics committee of Tehran University of Medical Sciences Pour Sina Ave, Qods St, Enghelab St Tehran Tehran Iran (Islamic Republic of)