Comparison of intravenous ketorolac versus intravenous morphine on pain relief in spinal traumatic patients: a double blind randomized controlled trial
Objectives: To assess the effect of intravenous ketorolac versus intravenous morphine on pain relief in spinal traumatic patients.
Design: A double blind randomized clinical trial.
Setting and conduct: The eligible spinal traumatic patients who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 15 to 66 years; spinal trauma.
Exclusion criteria: Pregnancy or breastfeeding; narcotic and alcohol addiction; thoracic pain; hemorrhage; low consciousness; liver disease; communication disorders.
Intervention group: Infusion of ketorolac 30 mg in 100 normal saline for 15 minutes.
Control group: Infusion of morphine 1 mg/kg in in 100 normal saline for 15 minutes.
Primary outcome: Assessing pain before intervention and 5, 15, 30, 45 and 60 minutes after intervention using visual analog scale.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705139014N162
Registration date:2017-05-31, 1396/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous ketorolac versus intravenous morphine on pain relief in spinal traumatic patients: a double blind randomized controlled trial
Public title
Comparison of intravenous ketorolac versus intravenous morphine on pain relief in spinal traumatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 15 to 66 years; spinal trauma.
Exclusion criteria: Pregnancy or breastfeeding; narcotic and alcohol addiction; thoracic pain; hemorrhage; low consciousness; liver disease; communication disorders.
Age
From 15 years old to 66 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.UMSHA.REC.1395.492
Health conditions studied
1
Description of health condition studied
Spinal trauma
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Pain
Timepoint
before intervention and 5, 15, 30, 45 and 60 minutes after intervention
Method of measurement
using visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Infusion of ketorolac 30 mg in 100 normal saline for 15 minutes.
Category
Treatment - Drugs
2
Description
Control group: Infusion of morphine 1 mg/kg in in 100 normal saline for 15 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Sajad Ghahramani
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Sajad Ghahramani
Position
Medical Student
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
Heroboy1371@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Rasoul Salimi
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
Rasoulsl@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)