Title: Comparison of the efficacy of intravenous paracetamol versus intravenous morphine plus diclofenac in treatment of renal colic
Purposes: Determination the severity of the pain on the basis of Visual Analogue Scale before treatment, 10 and 20 and 30 minutes and 24 hours after treatment.
Determination the time required for analgesia in apotel group and diclofenac plus morphine group.
Design, method and interventions: Among the all patients, 180 patients will be selected randomly.sample will be divided in two groups. In the first group after the diagnosis, 1 gram intravenous acetaminophen will be solved in 100 cc normal saline and will be infused in 10 minutes. In the second group 0.1 milligram morphine with 75 milligram diclofenac will be solved in 100 cc normal saline and will be infused in 10 minutes.
Inclusion criteria: Documented renal stone on the basis of CT scan or KUB
Exclusion criteria: Patients with NSAIDs contraindication; patients who have received opioid in the last 6 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405127327N3
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
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intravenous paracetamol versus intravenous morphine plus diclofenac in treatment of renal colic
Public title
Comparison of the efficacy of paracetamol versus intravenous morphine plus diclofenac in decreasing the pain of renal stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Documented renal stone on the basis of CT scan or KUB
Exclusion criteria: Patients with NSAIDs contraindication; patients who have received opioid in the last 6 hours.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
180
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 Sciences
Street address
Tabriz University of Medical Siences, Gholghasht Street, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
5/4/10986
Health conditions studied
1
Description of health condition studied
Pain due to renal stone
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain severity
Timepoint
In intrance, 10min, 20min, 30 min and 24 hour after treatment
Method of measurement
Visual analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After diagnosis, 1 gram intravenous acetaminophen will be solved in 100 cc normal saline and will be infused in 10 minutes.
Drug name: Apotel
Drug compound: Acetaminophen
Dose: one gram intravenous acetaminophen in 100 cc normal saline
Category
Treatment - Drugs
2
Description
Control group: 0.1 milligram morphine and 75 milligram diclofenac will be solved in 100 cc normal saline and will be infused in 10 minutes.
Drugs name: Morphine and Diclofenac
Dose: 0.1 milligram morphine and 75 milligram diclofenac in 100 cc normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Emergency Department of Imam Reza Hospital
Full name of responsible person
Street address
City
Tabirz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Student Research committee,Tabriz university of Medical Sciences
Full name of responsible person
Dr. Somaieh Halaj Nezhadi
Street address
Education development center, Daneshghah street, Tabriz
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 committee,Tabriz 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
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, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
Email
shams@tbzmed.ac.ir; sshamsv@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
Imam Reza Hospital, Gholghasht street, Tabriz
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)