Protocol summary

Summary
The Objective of this study is to compare the analgesic effect of intravenous paracetamol and acupuncture and intramuscular diclofenac in renal colic patients. This study is design as a clinical trial. In this patients with renal colic will be enrolled. They will be divided into three groups regard to random block method. IInclusion is patients with renal colic and aged between 18 and 50. exclusion criteria are: pregnancy; drug abuse; using pain killer before visit and underlying diseases. Patients will be asked to mark his/her pain regard to Visual Analogue Scale (VAS). Then they will receive 75 mg intramuscular diclofenac or 1 gram intravenous paracetamol or acupuncture (three points stimulation in 6 minutes). After interventions, pain score were evaluated after 10 minutes, 30 minutes and 60 minutes and results will be compared between groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072129023N1
Registration date: 2017-06-07, 1396/03/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Seyed Hasan HoseiniFaegh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
hoseinifh931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2017-05-17, 1396/02/27
Expected recruitment end date
2017-07-31, 1396/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The analgesic effect of intravenous paracetamol and acupuncture and intramuscular diclofenac in renal colic
Public title
intravenous paracetamol and acupuncture and intramuscular diclofenac in renal colic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion is patients with renal colic and aged between 18 and 50. exclusion criteria are: pregnancy; drug abuse; using pain killer before visit and underlying diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
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
Mashhad University of Medical Sciences
Street address
Iran, Mashhad, Qoriyshi building, Mashhad University of Medical Sciences
City
Mashhad
Postal code
1234567
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MUMS.fm.REC.1395.79

Health conditions studied

1

Description of health condition studied
Renal Colic
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
Pain severity
Timepoint
10 minutes, 30 minutes, 60 minutes
Method of measurement
visual analog scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
75 mg intramuscular diclofenac
Category
Treatment - Drugs

2

Description
1 gram intravenous paracetamol
Category
Treatment - Drugs

3

Description
acupuncture (three points stimulation in 6 minutes)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr. seyed Hasan Hoseini Faegh
Street address
Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreyshi Building, Daneshgah Strees, Mashhad, Iran
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 of 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 Sciences
Full name of responsible person
Dr. seyed Hasan Hoseini Faegh
Position
Resident
Other areas of specialty/work
Street address
Emam Reza Hospital-Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3841 1538
Fax
Email
HoseiniFH931@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. seyed Hasan Hoseini Faegh
Position
Resident
Other areas of specialty/work
Street address
Emam Reza Hospital-Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3841 1538
Fax
Email
HoseiniFH931@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. seyed Hasan Hoseini Faegh
Position
Resident
Other areas of specialty/work
Street address
Emam Reza Hospital-Emam Reza Square, Ebne Sina Avenue, Mashhad, Iran
City
Mashhad
Postal code
1234567
Phone
+98 19 5507 2364
Fax
Email
HoseiniFH931@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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