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IRCT20130108012072N12 IRCT 2020-11-27 Esfahan University of Medical Sciences Diazepam and Methocarbamol in spinal trauma efficacy The comparative study of clinical efficacy and palliative effect of adding Diazepam and Methocarbamol to Morphine in emergency department patients with spinal trauma 2020-12-21 anticipated 105 Complete https://irct.ir/trial/52034 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers. In this study, based on predefined 3-digit number (001,002,003,...) randomization table, blindly choose one number, then upper and below numbers choose vertically as treatment code for each patient. ٍAfter ending the the numbers, manager blindly choose another number again and apply the upper and below numbers for each patient. Every 3-digit number from 001 to 105, marked as one randomized treatment protocol (35 number for treatment protocol "A", 35 number for treatment protocol "B" and 35 number for treatment protocol "C"); study manager doesn't knowing about drug that use in each protocol. Chosen numbers must be lesser than sample size and greater numbers will be deleted. This protocol continued until all patients who meet inclusion criteria get a random number. Due to this method, patients stay on one treatment group, without knowing about treatment protocol, Blinding description: Drugs are preparing with scientist and labeled (scientist is blinded to patient's treatment group and efficacy or complications of each groups). Patients are selected with randomized numeric table and don't aware about treatment protocol. Manager use treatment pathway base on patient randomization; blinded about drug that be used and record result and complications. Statistical analyst, analyses the study without knowing about patients group and give the results to researcher for conclusion. 3 Spinal trauma. Intervention 1: Intervention group 1: 0.1 mg/kg Morphine (osvahpharma) diluted in 100 ml normal saline in 10 minutes infusion. Intervention 2: Intervention group 2: 0.1 mg/kg Morphine (osvahpharma) and 0.15 mg/kg Diazepam (caspiantamin) diluted in 100 ml normal saline in 10 minutes infusion. Intervention 3: Intervention group 3: 0.1 mg/kg Morphine (osvahpharma) and 1000 mg Methocarbamol (caspiantamin) diluted in 100 ml normal saline in 10 minutes infusion. Yes - There is a plan to make this available What will be shared: Whole of data after coding When: Accessibility after 2022 To whom: Everyone Conditions: For seemingly studies data released to academic chairman's Where to obtain: Isfahan University of Medical Sciences How to obtain: Emailing to m_esmailian@med.mui.ac.ir Comments:
public Mehrdad Esmailian
Hezarjerib Av., Isfahan
Isfahan Iran (Islamic Republic of) 8175898595 +98 31 3629 3482 m_esmailian@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehrdad Esmailian
Hezarjerib Av., Isfahan
Isfahan Iran (Islamic Republic of) 8175898595 +98 31 3629 3482 m_esmailian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Visual Analog Scale>4 No neurological signs No malignancy and underling disease No sensitivity to Morphine or Diazepam or Methocarbamol Blood Pressure >=110/70 mm Hg 18 years 65 years Both Drug user History of Opiods, Non-steroidal anti-inflammatory drugs (NSAID's) and muscle relaxant drug use in past 24 hours S34.1 Other and unspecified injury of lumbar and sacral spinal cord Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: 0.1 mg/kg Morphine (osvahpharma) diluted in 100 ml normal saline in 10 minutes infusion Intervention group 2: 0.1 mg/kg Morphine (osvahpharma) and 0.15 mg/kg Diazepam (caspiantamin) diluted in 100 ml normal saline in 10 minutes infusion Intervention group 3: 0.1 mg/kg Morphine (osvahpharma) and 1000 mg Methocarbamol (caspiantamin) diluted in 100 ml normal saline in 10 minutes infusion Pain severity score with Visual Analog Scale. Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Visual Analog Scale. Drug complications. Timepoint: Study beginning, 30 minutes and 1 hour and 2 hours after treatment. Method of measurement: Standard questionnaire form (Brief Medication Questionnaire). Insufficient pain control. Timepoint: 1 hour after treatment. Method of measurement: Visual Analog Scale. Esfahan University of Medical Sciences Approved 2020-05-31 Ethics committee of Isfahan University of Medical Sciences Alzahra general hospital, Sofeh blv., Isfahan Isfahan Isfehan Iran (Islamic Republic of)