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Comparison of The Efficacy Of DDAVP, Tramadol and Indomethacin in Alleviating the Pain In Patients With Acute Renal Colic

Protocol summary

Summary
Objective: Present study was designed to compare the efficacy of tramadol, desmopressin and indomethacin which are out-patiently prescribed in relieving the pain of renal colic caused by urolithiasis. Study design: This prospective, clinical, randomized trial was conducted in 120 patients (70 men and 50 women, mean age 38.2 years) referring to the emergency room with the renal colic caused by lithiasis without any previous treatment. Inclusion criteria: 120 patients referring to emergency room with renal colic caused by lithiasis without any previous treatment. Exclusion criteria: Patients with evidence of high blood pressure, coronary disease, rhinitis, influenza, anticoagulant therapy, and peptic ulcer, renal or liver failure were excluded from the study, as were any pregnant women. Interventions: In this clinical trial, 120 patients were randomly assigned to three groups: group A, received tramadol 50mg intramuscularly, group B, desmopressin 40 microgram intranasally and patients in group C received , indomethacin 100mg rectally for alleviating the pain. The pain was assessed by written form of VAS scale both on the admission and 30 minutes after therapy administration.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015030919470N18
Registration date: 2015-03-14, 1393/12/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-03-14, 1393/12/23
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2005-06-01, 1384/03/11
Expected recruitment end date
2006-06-01, 1385/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of The Efficacy Of DDAVP, Tramadol and Indomethacin in Alleviating the Pain In Patients With Acute Renal Colic
Public title
The Efficacy Of DDAVP, Tramadol and Indomethacin in Alleviating the Pain In Acute Renal Colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:120 patients (70 men and 50 women, mean age 38.2 years) referring to emergency room with renal colic caused by lithiasis without any previous treatment. exclusion criteria: Patients with evidence of high blood pressure, coronary disease, rhinitis, influenza, anticoagulant therapy, peptic ulcer, renal or liver failure were excluded from the study, as were any pregnant women.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2005-09-23, 1384/07/01
Ethics committee reference number
cp-p-8411-6410

Health conditions studied

1

Description of health condition studied
Acute Renal Colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic

Primary outcomes

1

Description
To investigate the amount of pain after tramadol 50mg intramuscular in acute renal colic
Timepoint
on the admission and 30 minutes after therapy administration
Method of measurement
VAS scale

2

Description
To investigate the amount of pain after desmopressin 40 microgram intranasally in acute renal colic
Timepoint
on the admission and 30 minutes after therapy administration
Method of measurement
VAS scale

3

Description
To investigate the amount of pain indomethacin 100mg rectally in acute renal colic
Timepoint
on the admission and 30 minutes after therapy administration
Method of measurement
VAS scale

Secondary outcomes

empty

Intervention groups

1

Description
Patients in group A, received tramadol 50mg intramuscularly for alleviating the pain
Category
Treatment - Drugs

2

Description
Patients in group B, received desmopressin 40 microgram intranasally for alleviating the pain
Category
Treatment - Drugs

3

Description
Patients in group C, received indomethacin 100mg rectally for alleviating the pain
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Alireza Aminsharifi
Street address
Zand Street, Faghihi Hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Aminsharifi
Position
Associate professor of Department of Urology/Urologist
Other areas of specialty/work
Street address
Department of Urology, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 0724
Fax
Email
aminsharifi_ar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Aminsharifi
Position
Associate professor of Department of Urology/Urologist
Other areas of specialty/work
Street address
Department of Urology, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 0724
Fax
Email
aminsharifi_ar@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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