Renal colic or acute flank pain is caused by the passage of urinary tract stones. The most important task in emergency room is to control this pain. Therefore, the aim of this study is to investigate the effect of intravenous acetaminophen to control pain in comparison with pethidine in patients with renal colic who had been referred to the emergency department. This study in a randomized clinical trial and single blind in which a sample of 100 patients with colic pain, aged between 18 to 60 years were used. Patients were randomly divided into two control and interventions groups. The control group was received pethidine and the intervention group is infused with acetaminophen. After the injection pain was assessed using visual analogue scale immediately after intervention, and 5, 10, 20 and 30 minutes following intervention. t-test and chi-square were used for analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090429690N1
Registration date:2016-10-14, 1395/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-14, 1395/07/23
Registrant information
Name
Mehdi Dashti
Name of organization / entity
Ardabil university Medical of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3344 5861
Email address
m.dashti@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil university of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous acetaminophen in comparison with pethidine for pain relief in renal colic
Public title
Comparison of intravenous acetaminophen and pethidine in pain renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 60 years old; pain score less than 8.
Exclusion criteria: pregnant women; breast feeding; have used painkillers in 6 hours before; renal dysfunction; warfarin therapy; using opioids; bleeding disorders; people who are addicted to drugs.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
End of University Avenue. Headquarters of Ardsbil University of medical sciences
City
Ardabil
Postal code
Approval date
2016-04-08, 1395/01/20
Ethics committee reference number
IR.ARUMS.REC.1395.46
Health conditions studied
1
Description of health condition studied
Renal Colic
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 5, 10, 20 and 30 minuts after intervention
Method of measurement
Visual Analogous Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : intravenous acetaminophen dose intravenous injections of acetaminophen 1 g in 100 ml of sodium chloride solution and the mixture was injected.
Category
Treatment - Drugs
2
Description
contorol group: 50 mg of pethedine intramuscularly was used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Fatemi Hospital
Full name of responsible person
Jafar Ghobadi
Street address
Fatemi hospital
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Shahram Habibzadeh
Street address
Deputy of research and technology . the headquarters of the Medical university of Ardabil .End of University Avenue . Ardabil
City
Ardabil
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, Ardabil 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
Aedabil University of Medical Sciences
Full name of responsible person
Jafar Ghobadi
Position
Faculty member
Other areas of specialty/work
Street address
Fatemi Hospital , Emam Street , Ardabil
City
Ardabil
Postal code
Phone
+98 45 3371 5023
Fax
Email
jafarghobadisamian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Jafar Ghobadi
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Ardabil Fatemi hospital , emam street , Ardabil
City
Ardabil
Postal code
Phone
+98 45 3371 5023
Fax
Email
jafarghobadisamian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mehdi Dashti
Position
General Practitioner
Other areas of specialty/work
Street address
the unit 5 , Block 54 , Behind the police station , Rizwan town , Ardabil
City
Ardabil
Postal code
Phone
Fax
Email
m.dashti@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)