The comparative study of clinical efficacy and palliative effect of adding Diazepam and Methocarbamol to Morphine in emergency department patients with spinal trauma

Efficacy of adding Diazepam and Methocarbamol to standard treatment in spinal trauma

Three arm triple blinded, parallel group, randomized clinical trial

Scientist prepare and label the drugs. Patients with spinal trauma who admitted in Alzahra and Kashani hospital (Isfahan city) divided in 3 groups after randomization and study manager start treating patient due to randomized numeric table; without knowing about treatment protocol. Patients in different groups receive below treatments: group 1: 10 minutes infusion of 0.1 mg/kg Morphine diluted in 100 ml normal saline group 2: 10 minutes infusion of 0.1 mg/kg Morphine and 0.15 mg/kg Diazepam diluted in 100 ml normal saline group 3: 10 minutes infusion of 0.1 mg/kg Morphine and 1000 mg Methocarbamol diluted in 100 ml normal saline Study observer check and record complications and pain severity with VAS (Visual Analog Scale) score in beginning of the study and after 30 minutes, 1 hour and 2 hour of treatment; without knowing about treatment protocol. Statistical analyzer, Analyze the study without knowing about patients group and give the results to researcher for conclusion.

Inclusion criteria: 18-65 years old; normal blood pressure; no malignancy and underling disease Non-Inclusion criteria: drug user; history of Opiods, Non-steroidal anti-inflammatory drugs (NSAID's) and muscle relaxant drug use in past 24 hours

Patients are divided in 3 group after randomization: group 1) receive IV Morphine group 2) receive IV Morphine and Diazepam group 3) receive IV Morphine and Methocarbamol group

ِDiazepam and Methocarbamol efficiency in patient pain control

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.

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.

Whole of data after coding

Accessibility after 2022

Everyone

For seemingly studies data released to academic chairman's

Isfahan University of Medical Sciences

Emailing to m_esmailian@med.mui.ac.ir