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IRCT20230302057587N1 IRCT 2023-04-17 Esfahan University of Medical Sciences Analgesic effect of Penthrox spray in patients with upper or lower limb fracture Evaluation of the effect of Penthrox spray as an analgesic compared to Morphine in patients with upper or lower limb fracture: A clinical trial study 2023-04-21 anticipated 25 Complete https://irct.ir/trial/68986 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using Permuted block randomization method, patients are placed in one of the two study groups and receive the intervention related to the same group, Blinding description: The participants, the principal investigator, the health care personnel (doctors, nurses, physiotherapists, etc.) responsible for the patient's care, the consultant professor, and the analyst were blinded. 3 Analgesics. Intervention 1: Intervention group: Methoxyflurane, a fluorinated hydrocarbon inhalation agent available in 3 cc ampoules, used in the Pentorax inhaler (manufactured by MDI, Melbourne, Australia). Three cc of methoxyflurane are poured into each spray. If the diluting valve is open, the spray emits 0.2-0.4%, and if it is closed, it releases 0.5-0.7% methoxyflurane. It also has an oxygen port. To administer methoxyflurane, we use a Pentorax inhaler with activated charcoal. The patient is asked to cover the diluting valve with his finger and put the nebulizer mouthpiece in his mouth, and exhale through the mouthpiece or nose. A maximum of 1 vial (equivalent to 3 ccs) is prescribed to each patient without supplemental oxygen. Each care provider administers methoxyflurane to two patients in his shift. Each inhaler is used only for one patient. Vital signs, including pulse rate, heart rate, oxygen saturation percentage, and body temperature, are recorded in each inhalation of Penthrox. All patients undergo cardiac monitoring, and if changes are made, they are recorded with an electrocardiogram. Any side effects caused by the drug, including hypotension, bradycardia, convulsions, decreased level of consciousness, itching, skin rash, and respiratory depression, are recorded. Every ten minutes, if the patient's pain level is 5.10, intravenous fentanyl with a dose of 1 microgram per kilogram of weight will be prescribed as a rescue dose. At the end of the meeting, the rescue dose of fentanyl will be recorded. Intervention 2: Control group: Intravenous morphine at a dose of 0.1 mg per kilogram of weight (manufactured by Daro Pakhsh Co., Tehran, Iran) will be infused. Every time the intravenous morphine is used, the vital signs including pulse rate, heart rate, degree of temperature and percentage of oxygen saturation are recorded. All patients undergo cardiac monitoring, and if changes are made, they are recorded with an electrocardiogram. Any side effects caused by the drug, including hypotension, bradycardia, convulsions, decreased level of consciousness, itching, skin rash, and respiratory depression are recorded. Every ten minutes, if the patient's pain level is 5.10, intravenous fentanyl with a dose of 1 microgram per kilogram of weight will be prescribed as a rescue dose, and at the end of the meeting, the rescue dose of fentanyl will be recorded. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammad Gulban
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 7898 mohammad_golban@yahoo.com Esfahan University of Medical Sciences scientific Reza Azizkhani
Ehsan Complex, Shkoufeh Alley, Gulkhane St., Khane Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3620 2085 Azizkhani.reza@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with upper or lower fracture Age between 20 to 55 Informed consent to participation in the study 20 years 55 years Both Impaired level of consciousness (Glasgow coma score less than 15) Hemodynamic disturbance during use (systolic blood pressure less than 90 mmHg, peripheral rate less than 60 beats per minute, breathing rate less than 8 per minute, blood oxygen saturation less than 90% Use of substances, alcohol, sedatives or pain relievers in the past 48 hours History of taking Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, Serotonin Receptors Reuptake Inhibitors, Phenothiazines, and sleeping pills Suffering from chronic diseases such as congenital or acquired heart diseases, chronic liver failure, bile duct diseases, kidney failure and chronic lung disease according to history and clinical examination. Allergy to Morphine or Penthrox Weight more than 100 kg Lack of informed consent Patient non-cooperation Y45.0 Opioids and related analgesics Treatment - Drugs Treatment - Drugs Intervention group: Methoxyflurane, a fluorinated hydrocarbon inhalation agent available in 3 cc ampoules, used in the Pentorax inhaler (manufactured by MDI, Melbourne, Australia). Three cc of methoxyflurane are poured into each spray. If the diluting valve is open, the spray emits 0.2-0.4%, and if it is closed, it releases 0.5-0.7% methoxyflurane. It also has an oxygen port. To administer methoxyflurane, we use a Pentorax inhaler with activated charcoal. The patient is asked to cover the diluting valve with his finger and put the nebulizer mouthpiece in his mouth, and exhale through the mouthpiece or nose. A maximum of 1 vial (equivalent to 3 ccs) is prescribed to each patient without supplemental oxygen. Each care provider administers methoxyflurane to two patients in his shift. Each inhaler is used only for one patient. Vital signs, including pulse rate, heart rate, oxygen saturation percentage, and body temperature, are recorded in each inhalation of Penthrox. All patients undergo cardiac monitoring, and if changes are made, they are recorded with an electrocardiogram. Any side effects caused by the drug, including hypotension, bradycardia, convulsions, decreased level of consciousness, itching, skin rash, and respiratory depression, are recorded. Every ten minutes, if the patient's pain level is 5.10, intravenous fentanyl with a dose of 1 microgram per kilogram of weight will be prescribed as a rescue dose. At the end of the meeting, the rescue dose of fentanyl will be recorded. Control group: Intravenous morphine at a dose of 0.1 mg per kilogram of weight (manufactured by Daro Pakhsh Co., Tehran, Iran) will be infused. Every time the intravenous morphine is used, the vital signs including pulse rate, heart rate, degree of temperature and percentage of oxygen saturation are recorded. All patients undergo cardiac monitoring, and if changes are made, they are recorded with an electrocardiogram. Any side effects caused by the drug, including hypotension, bradycardia, convulsions, decreased level of consciousness, itching, skin rash, and respiratory depression are recorded. Every ten minutes, if the patient's pain level is 5.10, intravenous fentanyl with a dose of 1 microgram per kilogram of weight will be prescribed as a rescue dose, and at the end of the meeting, the rescue dose of fentanyl will be recorded. Pain number in the Visual Analogue Scale (VAS). Timepoint: 10, 20, 30, 60 minutes after receiving the medicine. Method of measurement: The Visual Analogue Scale (VAS). Esfahan University of Medical Sciences Approved 2020-03-30 Ethical Committee of Isfahan University of Medical Sciences Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services Isfahan Isfehan Iran (Islamic Republic of)