Protocol summary

Summary
The purpose of the present study is to investigate the painkilling effect of morphine plus placebo in comparison with morphine plus tamsulosin. To do this research, we are going to carry out a randomized, double-blind study over 200 patients aged 18 to 55 presenting with acute renal colic to the emergency department of Imam Reza Hospital. Patients with one of the following criteria will be excluded from the study: opium addiction, pregnancy, any history of renal or hepatic disease and bilateral renal stones. After making sure that all of the inclusion criteria exist, the information about medicines’ advantages and side effects are provided to the participants and a written consent is obtained from the patients in case they agree to participate in the study. Then, the patients will be divided into two groups of A and B at a random selection without the researcher’s interference (based on the randomized block method using 200 Sequencing provided by statistics expert). Before the administration of the chosen drug, the patients are asked to determine their pain level based on the visual analogue scale (VAS) using the ruler of VAS which is given to them. Group A patients will be treated with 0.1 mg/kg IV morphine plus 0.4 mg of oral tamsulosin produced by Tasnim pharmaceutical company and Group B patients will be treated with the same dose of IV morphine plus placebo (empty tablet shells provided by Tasnim pharmaceutical Co., having the same shape as tamsulosin tablets, filled with starch). After 30 minutes, 2, 4 and 6 hours of the drug administration, the patients’ pain level will be evaluated again based on VAS using the ruler of VAS that has been given to the patients. Finally, data collected from the two groups will be compared and analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101311956N9
Registration date: 2017-03-11, 1395/12/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-11, 1395/12/21
Registrant information
Name
Morteza Talebi Doluee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
talebidm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-10-21, 1395/07/30
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of morphine and tamsulosin with morphine alone in pain management of renal colic patients
Public title
A comparison of the effect of morphine and tamsulosin with morphine alone in pain management of patients with renal stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with renal colic; age between 18 to 55 years old. exclusion criteria: any history of opium addiction; pregnancy; any history of renal or hepatic disease; bilateral renal stones
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ethics Committee, Ghoreishi building, Daneshgah ave.
City
Mashhad
Postal code
Approval date
2016-09-11, 1395/06/21
Ethics committee reference number
IR.mums.fm.REC.1395.127

Health conditions studied

1

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

Primary outcomes

1

Description
Pain
Timepoint
Before analgesic administration and 30 minutes , 2 , 4 and 6 hours after analgesic administration
Method of measurement
Visual analoge scale

Secondary outcomes

1

Description
headache
Timepoint
30 minutes , 2 , 4 and 6 hours after analgesic administration
Method of measurement
Questionnaire

2

Description
dizziness
Timepoint
30 minutes , 2 , 4 and 6 hours after analgesic administration
Method of measurement
questionnaire

Intervention groups

1

Description
We administer morphine sulfate 0.1 mg/kg IV with oral tamsulosin 0.4 mg for the first group of patients.
Category
Treatment - Drugs

2

Description
We administer morphine sulfate 0.1 mg/kg IV with placebo for the second group of patients.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital,Edalatian emergency center
Full name of responsible person
Dr Morteza Talebi, Emergency Medicine specialist
Street address
Imam Reza sq , Ebnesina ave.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Siences
Full name of responsible person
Dr. Aida Shams Hojati
Position
MD, Resident of Emergency Medicine
Other areas of specialty/work
Street address
Department of emergency medicine , Imam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3762 3320
Fax
Email
shamsa931@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Emergency Medicine , Mashhad University of Medical Siences
Full name of responsible person
Dr. Morteza Talebi
Position
Emergency medicine specialist , assistant professor of emergency medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Square, Ebne Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
talebimd@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Siences
Full name of responsible person
Dr. Aida Shams Hojati
Position
MD, Resident of Emergency Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Imam Reza Square, Ebne Sina Avenue
City
Mashhad
Postal code
Phone
+98 51 3762 3320
Fax
Email
shamsa931@mums.ac.ir
Web page address

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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