Comparison of the efficacy and safety of pethidine, Diclofenac suppository and combination of them on duration of hospitalization of renal colic patients in Imam Reza Hospital Kermanshah 1389
This study was a single blind randomized clinical trial performed to compare Pethidine, Diclofenac Suppository and a combination of these two drugs on Renal Colic pain in Emergency Department of Imam Reza Hospital. A total of 90 patients with acute renal colic, aged 18 to 60 years old, were randomly assigned to receive pethidine injection 50 mg, diclofenac suppository, 50 mg or combination the two drugs on arrival and 30 minutes later. The intensity of pain was measured at the baseline and 10 minutes after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012145389N1
Registration date:2011-03-24, 1390/01/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-24, 1390/01/04
Registrant information
Name
Soodeh Shahsavari
Name of organization / entity
university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6299
Email address
crdu@irhk.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-12-26, 1389/10/05
Expected recruitment end date
2011-02-24, 1389/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of pethidine, Diclofenac suppository and combination of them on duration of hospitalization of renal colic patients in Imam Reza Hospital Kermanshah 1389
Public title
Efficacy of pethidine, Diclofenac suppository and combination of them on duration of hospitalization of renal colic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: clinical diagnosis of acute renal colic (colic Flank pain may be associated with urinary symptoms including urinary frequency, dysuria, or hamaturia. Other causes of flank pain should be ruled out by P/E or ultrasound), age 18 to 60 years, pain intensity more than 5 according to VAS
Exclusion criteria: Pregnancy, breast feeding, analgesic consumption in six hours prior to the intervention, presence of renal failure, warfarin consumption, contraindication of NSAIDs or opioids consumption, presence of bleeding tendency, drug addiction
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti Bouelvard, Kermanshah
City
Kermanshah
Postal code
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
6638
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N22
ICD-10 code description
Calculus of urinary tract in diseases classified elsewhere
Primary outcomes
1
Description
pain
Timepoint
befoer and 30 minutes after the intervention
Method of measurement
vas scale
2
Description
hospital stay
Timepoint
At discharge from hospital
Method of measurement
Registration records
Secondary outcomes
1
Description
Hypertension
Timepoint
15,30, and 40 minutes after the intervention
Method of measurement
sphygmomanometer
2
Description
Nausea
Timepoint
15,30, and 40 minutes after the intervention
Method of measurement
Asking from the patient
Intervention groups
1
Description
Pethidine, 50 mg IV injection, on arrival and 30 minutes later
Category
Treatment - Drugs
2
Description
Diclofenac, 50 mg Suppository, on arrival and 30 minutes later
Category
Treatment - Drugs
3
Description
Pethidine, 50 mg IV injection as well as Diclofenac, 50 mg Suppository, on arrival and 30 minutes later
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Imam Reza Hospital
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr Farid Najafi
Street address
Building No.2, Shahid Beheshti Bouelvard, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences and Health Services
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
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr Ali Taherinia
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6299
Fax
Email
dr_alitaheri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Full name of responsible person
Dr Ali Taherinia
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6299
Fax
Email
dr_alitaheri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences and Heath Services
Full name of responsible person
Soodeh Shahsavari
Position
MS in Biostatistics/Clinical Research Department Unit
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)