Protocol summary

Study aim
Comparison of the effect of sodium Diclofenac suppository and muscle Pethidine on the severity of acute colic renal
Design
In this double-blind clinical trial,72 people with colic renal,received one of the studied treatments with the opinion of a physician and were divided into two parallel groups.
Settings and conduct
the emergency department of Razi Hospital in Birjand؛from December 28 to February 30 Data were collected after the necessary investigations and obtaining consent to enter the research and fill out the checklist. Then,1: 1 was divided into two groups of 36 people,and demographic information was matched between the two groups.The first group was given a 100mg Diclofenac suppository and the second group was given a 50mg Pethidine ampoule,and information was collected using the VAS (Visual Analog Scale)system.
Participants/Inclusion and exclusion criteria
Inclusion criteria:People who go with acute renal colic. Exclusion criteria:peptic ulcer؛hemorrhoids and anal fissure؛ pregnancy؛IBD؛coagulopathy؛heart disease؛COPD؛liver disease؛asthma؛lactating women؛those who received analgesics 6 hours before entering the emergency room and allergies to NSAIDs.
Intervention groups
In this study,72 blind people with acute renal colic,who had similar pain due to the mental nature of the previous pain,Then,1:1 was divided into two groups of 36 people,and demographic information was matched between the two groups.The first group was given a 100mg diclofenac suppository and the second group was given a 50mg petadine ampoule.
Main outcome variables
Age,sex,pregnancy,weight,drug use;history of hemorrhoids and anal fissures;history of coagulopathy;inflammatory bowel disease;history of peptic ulcer;heart disease;liver disease;COPD;renal failure;NSAID susceptibility;warfarin use;diabetes;asthma;lactation;analgesia 6 hours before onset;pain pattern at onset;10,20 and 30 minutes after taking the drug.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200418047123N1
Registration date: 2020-05-04, 1399/02/15
Registration timing: retrospective

Last update: 2020-05-04, 1399/02/15
Update count: 0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Masoud Mozaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3276 3099
Email address
s.salehes1174@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
2020-02-19, 1398/11/30
Actual recruitment end date
2020-04-18, 1399/01/30
Trial completion date
2020-04-18, 1399/01/30
Scientific title
Comparison of the effects of rectal Diclofenac sodium and intramuscular Pethidine injection on severity of acute renal colic pain
Public title
Comparison of the effects of rectal diclofenac sodium and intramuscular pethidine injection on severity of acute renal colic pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
people who had similar pain with acute renal colic due to the mental nature of the previous pain
Exclusion criteria:
Peptic Ulcer Hemorrhoids and anal fissures Pregnancy COPD IBD Coagulopathy Heart disease Liver disease Asthma Breastfeeding Those who received painkillers 6 hours before entering the emergency room. Allergies to NSAIDs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 72
Actual sample size reached: 72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the study received consent, but did not know which of the two drugs they were taking. Also, when evaluating the data, the analyst does not know the type of drug received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences,Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.BUMS.REC.1398.329

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 intensity in Visual Analogue Scale system
Timepoint
Measure the severity of the pain at the beginning of the visit and 10, 20 and 30 minutes after receiving the drug
Method of measurement
Visual Analogue Scale system

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first group: 36 patients with colic Renal who receive a diclofenac suppository at a dose of 100 mg.
Category
Treatment - Drugs

2

Description
Intervention group: 36 patients with renal colic receiving a dose of 50mg of pethidine ampoules.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Seyed Masoud Mozaffari
Street address
Birjand University of Medical Sicences؛Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3276 3099
Email
s.salehes1174@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Birjand University of Medical Sicences,Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3276 3099
Email
s.salehes1174@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masoud Mozaffari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Valieasr hospital,Ghaffari blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3276 3099
Fax
Email
s.salehes1174@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masoud Mozaffari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Valieasr hospital,Ghaffari blvd
City
Birjand
Province
South Khorasan
Postal code
9783117444
Phone
+98 56 3276 3099
Fax
Email
s.salehes1174@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masoud Mozaffari
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Valieasr hospital,Ghaffari blvd
City
Birjand
Province
South Khorasan
Postal code
9783117444
Phone
+98 56 3276 3099
Fax
Email
s.salehes1174@bums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
In this study, after identifying people, all the information obtained from the variables can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Information is available to everyone
Under which criteria data/document could be used
Research projects
From where data/document is obtainable
Birjand University of Medical Sciences Postal code 9717853577 and address www.bums.ac.ir
What processes are involved for a request to access data/document
Send a request to the Research Committee of Birjand University of Medical Sciences
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