Comparison of the Efficacy of the Addition of Methocarbamol or Diazepam to Morphine to Reduce Acute Low Back Pain in the Emergency Department
Design
Randomized double-blind clinical trial
Settings and conduct
It is conducted in 3 university hospitals.
The syringes are similar in volume and color.
Participants/Inclusion and exclusion criteria
Adult patients (18 years or older) were included with acute low back pain (LBP) which was aggravating or commencing in the last 2 weeks.
Exclusion Criteria consisted of renal or hepatic insufficiency, pregnancy or breastfeeding, and unstable vital signs (pulse rate<50 or >150 beats/min, systolic blood pressure <90), and patients who had already received analgesics in the past 24 hours.
Intervention groups
Group 1: Methocarbamol 100mg/10ml intravenous in 3 minutes infusion, then morphine 6 milligram (mg) was prescribed.
Group 2: Diazepam 5 mg diluted with 9 milliliter normal saline and infused during 3 minutes then, morphine 6 mg intravenously was prescribed.
Main outcome variables
Comparison of the Efficacy of the Addition of Methocarbamol or Diazepam to Morphine to Reduce Acute Low Back Pain in the Emergency Department
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151113025025N4
Registration date:2020-08-09, 1399/05/19
Registration timing:prospective
Last update:2020-08-09, 1399/05/19
Update count:0
Registration date
2020-08-09, 1399/05/19
Registrant information
Name
Maryam Bahreini
Name of organization / entity
Tehran University of Medical Sciences, Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1413
Email address
m-bahreini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-20, 1399/05/30
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Methocarbamol-Morphine and Diazepam-Morphine to Reduce Acute Low Back Pain in Adult Patients in the Emergency Department
Public title
Comparison of the Efficacy of Methocarbamol-Morphine and Diazepam-Morphine to Reduce Acute Low Back Pain in Adult Patients in the Emergency Department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (18 years or older)
acute low back pain (LBP)
aggravating or commencing in the last 2 weeks
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization of 4
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind (patients and outcome investigator)
Syringes have similar volume and color
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Emergency Department, Sina Hospital, Imam-Khomeini Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.564
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.4
ICD-10 code description
Lumbago with sciatica
Primary outcomes
1
Description
Comparison of the Efficacy of the Addition of Methocarbamol or Diazepam to Morphine to Reduce Acute Low Back Pain in the Emergency Department
Timepoint
0, 30 and 60 minutes
Method of measurement
Numeric rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Methocarbamol 100mg/10ml intravenous in 3 minutes infusion, then morphine 6 milligram (mg)
Category
Treatment - Drugs
2
Description
Intervention group: Diazepam 5 mg diluted with 9 milliliter normal saline and infused during 3 minutes then, morphine 6 mg intravenously