Title: Comparison of paracetamol versus ketorolac on decreasing of low back pain.
Purposes: Appointment of the severity of the pain on the basis of VAS in patients with chief complaint of low back pain before treatment, 10 and 20 and 30 minutes and 24 hours after treatment in apotel, intravenous keterolac group.
Design, method and interventions:Among the all patients with chief complaint of low back pain, 180 patients will be selected randomly. Sample will be divided in two groups randomly. In first group after diagnosis, 1 gram intravenous acetaminophen will be soluted in 100 cc normal saline and will be infused in 10 minutes. In the second group, a ketorolac ampule in order to stimulation will be soluted in 100 cc normal saline and will be infused in 10 minutes.
Inclusion criteria: Patients between 18 up to 65 years old with chief complaint of low back pain.
Exclusion criteria: Patients who have contraindication for use of NSAID; use of opioid in last six hours; patients with red flag symptoms such as neurological abnormalities or fever; patients with suggestive signs for discopathy in MRI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404127327N1
Registration date:2015-02-01, 1393/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-01, 1393/11/12
Registrant information
Name
Samad Shams Vahdati
Name of organization / entity
Tabriz University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 41 1658 1401
Email address
shams@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-06-05, 1393/03/15
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of paracetamol versus ketorolac on decreasing of low back pain: clinical trial
Public title
Comparison of paracetamol versus ketorolac on decreasing of low back pain: clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 18 up to 65 years old with chief complaint of low back pain.
Exclusion criteria: Patients who have contraindication for use of NSAID; use of opioid in last six hours; patients with red flag symptoms such as neurological abnormalities or fever; patients with suggestive signs for discopathy in MRI.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Ethics Committee,Tabriz University of medical science
Street address
Central Building Number 2, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
5/4/10985
Health conditions studied
1
Description of health condition studied
Low back paine
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
Pain severity
Timepoint
In intrance, after 10, 20, 30 minute and 24 hour later
Method of measurement
Visual Analoge score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After confirming diagnosis, 1 gram paracetamol will be soluted in 100 cc normal saline and will be infused in 10 minute.
Drug name: Intravenous Paracetamol
Chemical compound: Acetaminophen
Dose: 1 gram acetaminophen in 100 cc normal saline
Category
Treatment - Drugs
2
Description
Control group: one ampule of ketorolac in order to stimulation will be soluted in 100 cc normal saline and will be infused in 10 minutes.
Drug name: Ketorolac
Chemical compound: Ketorolac
Dose: one ampule of ketorolac with dosage of 30 milligram per milliter.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Samad Shams Vahdati
Street address
Gholghasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student Research Commitee, Tabriz University of Medical Science
Full name of responsible person
Dr. Somaieh Halaj Nezhadi
Street address
Education Development Center, Daneshghah street,
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student Research Commitee, Tabriz University of Medical Science
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
Tabriz University of Medical sciences
Full name of responsible person
Dr. Samad Shams Vahdati
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Gholghasht street
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
Email
shams@tbzmed.ac; irsshamsv@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Dr. Samad Shams Vahdati
Position
َAssistant professor of emergency medicine
Other areas of specialty/work
Street address
Gholghasht street, Imam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
Email
shams@tbzmed.ac.ir; sshamsv@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)