Determining the effectiveness of fluid treatment on the pain intensity of patients with renal colic
Design
Two arm parallel group, single-blinded, randomized controlled clinical trial on 60 patients with renal colic pain. An online tool will be used for randomization.
Settings and conduct
This study is conducted on patients with renal colic pain referred to the emergency department of Shahid Bahonar Hospital in Kerman. The patients are randomly divided into the intervention and control groups. The patients in the intervention group will be given 1000 cc of additional IV fluid treatment along with analgesia. Patients in the control group will receive only analgesia. Due to the nature of the study, only patients are blinded to the study, which can be done by covering the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years old with renal colic; Pain score over 5 based on VAS; Consent to participate in the study.
Exclusion criteria: History of underlying heart and kidney diseases; Pregnant women; Receiving analgesics in the last 2 hours; High blood pressure; Patients whose pain is due to causes other than renal colic.
Intervention groups
Intervention group 1: will receive analgesia along with 1000 cc of additional IV fluid treatment. Intervention group 2: As a control group, will only receive analgesia.
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220822055774N2
Registration date:2024-03-14, 1402/12/24
Registration timing:prospective
Last update:2024-03-14, 1402/12/24
Update count:0
Registration date
2024-03-14, 1402/12/24
Registrant information
Name
Masomeh Nazemirafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 2955
Email address
m_nazemi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Fluid Treatment on the Pain Intensity of Patients with Renal Colic
Public title
Effects of Fluid Treatment on Renal Colic Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with renal colic
Pain score over 5 based on Visual Analogue Scale (VAS)
Consent to participate in the study
Exclusion criteria:
History of underlying heart and kidney diseases
Pregnant women
Receiving analgesics in the last 2 hours
High blood pressure
Patients whose pain is due to causes other than renal colic
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method is simple. By using randomization software (www.graphpad.com), the numbers (from one to the sample size) are randomly distributed equally between the intervention and control groups. This assignment is written on the cards and the envelopes are sealed. The randomization process is done by someone outside the study. Assignment will be concealed until the end of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single-blind. After receiving the consent from the patient, and opening the envelope, the group assigned to the patient will be determined. The fluid treatments (for the intervention and control groups) are covered in such a way that the patient does not know the amount. However, the nurses and the person responsible for data collection are aware of the assigned group (once the envelope is opened).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences campus, Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616914115
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.KMU.AH.REC.1402.215
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 the intervention and 20, 40 and 60 minutes after the intervention
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive analgesia along with 1000 cc of additional IV fluid treatment.
Category
Treatment - Drugs
2
Description
Control group: Will only receive analgesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Masoume Nazimi Rafi
Street address
Shahid Bahonar Hospital, Qorani St, Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 913 493 6949
Email
m_nazemi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Afzalipour Medical School, Pazhoohesh Square, 22 Bahman Blvd, Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3132 0500
Email
Iranpourabedin89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Masomeh Nazemirafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No.4, East Ave.,14 Jomhori Blvd., Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3211 2955
Fax
Email
m_nazemi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masomeh Nazemirafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No.4, East Ave.,14 Jomhori Blvd., Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3211 2955
Fax
Email
m_nazemi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masomeh Nazemirafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No.4, East Ave.,14 Jomhori Blvd., Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3211 2955
Fax
Email
m_nazemi@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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