Achieving a longer lasting analgesic effect in renal colic patients
Design
A clinical trial without a control group, with parallel groups, double-blind, randomized, phase 2 on 108 patients, simple randomization method by number table was used for randomization.
Settings and conduct
The location of the study is Imam Khomeini (RA) Ilam Hospital, which is in the field of treating patients with renal colic. First, the pain level of each patient is recorded; Then the patients are randomly divided into 3 groups, the first group is given 25 mg of pethidine, the second group is given 30 mg ketorolac, and the third group is given a combination of 2 drugs. The medicinal solution is given to the patients by a nurse who has no knowledge of the study protocol. There is no information about the medicinal solution of different groups and there is no difference between them. If the verbal score of "no pain" or "much better pain" is not obtained, the life-saving drug pethidine 25mg this time is in the form of iv slow injection to be repeated every 15 minutes if needed. The functional status of the patient is calculated as follows: weak impairment: able to return to work and drive a car; moderate impairment: able to perform daily activities at home; severe impairment: confined to bed.
Participants/Inclusion and exclusion criteria
Eligibility: Renal colic patients with clinical and radiological diagnosis of kidney stones
Exclusion conditions: 1_Pregnant women
2_Nursing mothers
3_Persons with kidney dysfunction before
4_Patients treated with warfarin
5_Patients with bleeding disorders
6_Persons with a history of gastrointestinal problems after taking NSAIDS
Intervention groups
The first group is injected with 25 mg of pethidine
the second group is injected with 30 mg of ketorolac
and the third group is injected with a combination of ketorolac and pethidine.
Main outcome variables
Pain relief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221229056978N1
Registration date:2023-02-10, 1401/11/21
Registration timing:prospective
Last update:2023-02-10, 1401/11/21
Update count:0
Registration date
2023-02-10, 1401/11/21
Registrant information
Name
Amir reza Eidypour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3323 4131
Email address
amir.eidypour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic efficacy of pethedine and ketorolac in renal colic patients referred to imam khomeini hospital ilam city in 2022
Public title
Comparison of the analgesic efficacy of pethedine and ketorolac in renal colic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All renal colic patients who have been confirmed by clinical and laboratory diagnosis
Exclusion criteria:
Women who are pregnant
Breastfeeding mothers
Patients who received sedation less than 6 hours before arrival
People with kidney dysfunction
Patients treated with warfarin
Patients with gastrointestinal disorders after taking NSAIDs
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are individually divided into 3 groups by a simple randomization method by a table of numbers in such a way that each person is assigned a number according to the table and then randomly any number from the box The number 1 to 108 is placed in it, the first number is placed in the first group, the second number is placed in the second group, and the third number is placed in the third group, and the randomization continues in this way until the end, and none of the patients from The groupings and the difference between the intervention of the groups are no longer known.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients (participants) are not aware of the groupings and that the injection solution of each group is different, and the solution will be injected by a nurse who will not have any knowledge of the composition of the solution and the difference of the injection solution of different groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences campus.,Pazhouhesh Blvd.,Banganjab.,Ilam
City
Ilam
Province
Ilam
Postal code
6939177134
Approval date
2022-09-19, 1401/06/28
Ethics committee reference number
IR.MEDILAM.REC.1401.133
Health conditions studied
1
Description of health condition studied
Investigation of pain in renal colic patients
ICD-10 code
23
ICD-10 code description
Diseases of the genitourinary system
Primary outcomes
1
Description
Pain level of renal colic patients
Timepoint
Pain measurement before the start of the intervention in all three groups, upon arrival and 35 minutes in the pethidine group, upon arrival and 3 minutes in the ketorolac group, and upon arrival and 35 minutes in the combination solution group of ketorolac and pethidine.
Method of measurement
The method of measurement of the qualitative study is based on the functional status as follows: Weak impairment: able to return to work and drive a car 2_Mild impairment: able to perform daily activities at home 3_Severely injured: confined to bed
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group receives 25 mg pethidine
Category
Treatment - Drugs
2
Description
Intervention group: The second group receives 30 mg ketorolac
Category
Treatment - Drugs
3
Description
Intervention group: The third group receives a combination solution of pethidine and ketorolac
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Amirreza Eidypour
Street address
Ilam, Ayatollah Heydari St
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 87 3333 4500
Email
amir.eidypour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Abas Maleki
Street address
Ilam University of Medical Sciences campus.,Pazhouhesh Blvd.,Banganjab.,Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7103
Email
amir.eidypour@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Hosein Seyedkhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Ilam University of Medical Sciences campus.,Pazhuhesh Blvd.,Banganjab.,Ilam Town
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
hseidkhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Aref Teymourinejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No.7,Taqavi dead end.,Nehzat Ave.,Ilam Town
City
Ilam
Province
Ilam
Postal code
61931854443
Phone
+98 84 3222 7154
Email
arefteymourinejad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Amirreza Eidypour
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Street behind veterinary medicine
City
Eyvan
Province
Ilam
Postal code
6941644883
Phone
+98 84 3323 4131
Email
amir.eidypour@gmail.com
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