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IRCT2012111710585N1 IRCT 2013-03-20 The vice chancellor for research,The medical school of Tehran University of Medical Science Intravenous Morphine sulfate versus nebulized Fentanyl in patients with acute pain. Effect of nebulized Fentanyl in relief pain due to acute limb trauma and comparing it with intravenous Morphine sulfate. 2012-11-19 anticipated 90 Complete https://irct.ir/trial/11054 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Other design features: In this study we had two similar packages of drugs that had prepared with study headmaster. Both of them included two 10 milliliter syringes that had filled with clear liquid by headmaster of study; Patients randomly treated with one of the packages that randomized by 4 digits block manner. Our study is triple blind because researcher, patients and analyzer of results did not know anything about contents of each package. 2 Acute limb trauma. Intervention 1: In group 1 or intervention group patients received drug and placebo in 2 syringes that were filled by study headmaster. Both of the syringes contained 10 milliliter of clear liquid. Syringe number 1 contained 10 milliliters distilled water as placebo for intravenous injection by dose of 0.1 milliliter/kilogram of body weight within 1 minute. Syringe number 2 contained 10 milliliter of 50 Micro gram/milliliter of Fentanyl that build in Iranian drug industry (Daroupakhsh or Abureihan). Fentanyl prescribed via nebulizer by dose of 0.08 milliliter/kilogram equal to dose of four Micro gram/Kilogram within 5 minutes after intravenous drug. Patients had been monitored for change in pain scale by 10 number Numerical Pain Score (NRS) and side effects in 5, 10, 15, 30 and 60 minutes after receiving drug via nebulizer by asking them with a questionnaire. Patients who had not reported decrease in pain scale at least 3 number, 15 minutes after nebulized drug, received 1 milligram rescue dose of morphine sulfate intravenously at times 15 and 30 minutes after nebulized drug. Intervention 2: In group 2 or control group patients received drugs in 2 syringes that were filled by study headmaster and both of them contained 10 milliliters of clear liquid. Syringe number 1 contains 10 milliliters of morphine sulfate; build in Iranian drug industry (Daroupakhsh or Abureihan) that diluted to 1 milligram/milliliter for intravenous injection. Intra venous Morphine sulfate prescribed by dose of 0.1 milliliter/kilogram equal to 0.1 milligram/kilogram of body weight within 1 minute. Syringe number 2 contains 10 milliliter of distilled water as placebo for prescription via nebulizer by dose of 0.08 milliliter/kilogram within 5 minutes after intravenous drug. Patients had been monitored for change in pain scale by 10 number Numerical Pain Score (NRS) and side effects in 5, 10, 15, 30 and 60 minutes after receiving drug via nebulizer by asking them via questionnaire. Patients who had not reported decrease in pain scale at least 3 number, 15 minutes after drugs, received 1 milligram rescue dose of Morphine sulfate intravenously.
public Dr. Shervin Farahmand
Emergency department of Imam Khomeini's Hospital, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) +98 21 6690 4848 shfarahmand@sina.tums.ac.ir Tehran University of Medical Science scientific Dr. Shervin Farahmand
Emergency department of Imam Khomeini's Hospital, Keshavarz Blvd.
Tehran Iran (Islamic Republic of) +98 21 6690 4848 shfarahmand@sina.tums .ac.ir Tehran University of Medical Science Iran (Islamic Republic of) Inclusion criteria: all patients who presented to our ED and were complaining pain due to acute limb trauma with severity index of pain at least 5 of 10 in Numerical Pain Score (NRS). Exclusion criteria: special group of patients (pregnant, breast feeding); history of respiratory disease such as asthma; patients who were receiving neuroleptic drugs; patients with chronic pain, opium or alcohol addiction or chronic use of analgesics. 16 years 50 years Both S40, S41, Superficial injury to shoulder and upper arm, Open wound of shoulder and upper arm, fracture of shoulder and upper arm, Dislocation, sprain and strain of joints and ligaments of shoulder girdle, Superficial injury of forearm, Open wound of forearm, Fractu Treatment - Drugs Treatment - Drugs In group 1 or intervention group patients received drug and placebo in 2 syringes that were filled by study headmaster. Both of the syringes contained 10 milliliter of clear liquid. Syringe number 1 contained 10 milliliters distilled water as placebo for intravenous injection by dose of 0.1 milliliter/kilogram of body weight within 1 minute. Syringe number 2 contained 10 milliliter of 50 Micro gram/milliliter of Fentanyl that build in Iranian drug industry (Daroupakhsh or Abureihan). Fentanyl prescribed via nebulizer by dose of 0.08 milliliter/kilogram equal to dose of four Micro gram/Kilogram within 5 minutes after intravenous drug. Patients had been monitored for change in pain scale by 10 number Numerical Pain Score (NRS) and side effects in 5, 10, 15, 30 and 60 minutes after receiving drug via nebulizer by asking them with a questionnaire. Patients who had not reported decrease in pain scale at least 3 number, 15 minutes after nebulized drug, received 1 milligram rescue dose of morphine sulfate intravenously at times 15 and 30 minutes after nebulized drug. In group 2 or control group patients received drugs in 2 syringes that were filled by study headmaster and both of them contained 10 milliliters of clear liquid. Syringe number 1 contains 10 milliliters of morphine sulfate; build in Iranian drug industry (Daroupakhsh or Abureihan) that diluted to 1 milligram/milliliter for intravenous injection. Intra venous Morphine sulfate prescribed by dose of 0.1 milliliter/kilogram equal to 0.1 milligram/kilogram of body weight within 1 minute. Syringe number 2 contains 10 milliliter of distilled water as placebo for prescription via nebulizer by dose of 0.08 milliliter/kilogram within 5 minutes after intravenous drug. Patients had been monitored for change in pain scale by 10 number Numerical Pain Score (NRS) and side effects in 5, 10, 15, 30 and 60 minutes after receiving drug via nebulizer by asking them via questionnaire. Patients who had not reported decrease in pain scale at least 3 number, 15 minutes after drugs, received 1 milligram rescue dose of Morphine sulfate intravenously. Pain score which is reported by patient. Timepoint: Five, 10, 15, 30 and 60 minutes after receiving drugs. Method of measurement: Questionnaire by Numerical Pain Scale(NRS). Respiratory rate. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Questionnaire. Patient's Global rating of satisfaction. Timepoint: One hour after receiving drug via nebulizer. Method of measurement: Questionnaire. The period of time between treatment and the onset of analgesia. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Questionnaire. Total dose of rescue dose of Morphine sulfate. Timepoint: Since 15 minutes after receiving drug via nebulizer. Method of measurement: milligram. The percentage of arterial Oxygen saturation. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Percent. Systolic and diastolic blood pressure. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: millimeter of mercury. Heart rate. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Beat per minute. Level of consciousness. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Questionnaire. The number of reported nausea or vomiting. Timepoint: Five, 10, 15, 30, 60 minutes after receiving drugs. Method of measurement: Questionnaire. The vice chancellor for research,The medical school of Tehran University of Medical Science Approved 2012-10-11 Ethics committee of Tehran University of Medical Science Room 501, floor 5, Central building of Tehran University of Medical Science Tehran Iran (Islamic Republic of)