Comparison between the clinical efficacy of Intravenous fentanyl and ketorolac in reliving renal colic pain and choosing a more appropriate drug with less side effects.
Design
Patients will be examined after obtaining a consent, history and demographic information. Eligible patients entering the study are randomly divided into two groups by permuted balanced block randomization. A group receive intravenous fentany and another group receive of intravenous ketorolac. Dosage are determined based on similar studies and responses to their treatment.Patients receive 5 mg of IM morphine if the VAS rate exceeds 50% after 60 minutes.The severity of the pain is measured by the VAS questionnaire. The body temperature, HR, BP, and VAS are recorded before treatment and then at intervals of 20 minutes to 60 minutes. Patients are also screened for side effects of drugs.Calculations were performed using G * power software.
Settings and conduct
The study was designed in patients with renal colic as a single blind in Kowsar Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with unilateral abdominal or flank pain suspect to renal colic that confirm by paraclinics or the stone passage by the patient.
Exclusion criteria: En Visual Analog Scale≤3; history of peptic ulcer disease , asthma and bleeding disorder; using of oral anticoagulant, sedative, antipsychotic, MAO-I, painkillers within 6 hours before; impaired renal or hepatic function.
hypersensitivity to Aspirin or NSAID or Fentanyl; pregnant or breast-feeding women; younger than 18 and greater than 55 years old.
Intervention groups
Treatment of patients with acute colic pain with intravenous fentanyl and ketorolac
Main outcome variables
Determining and comparing the clinical efficacy of intravenous ketorolac and fentanyl in relieving pain in renal colic patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150902023855N3
Registration date:2020-07-14, 1399/04/24
Registration timing:registered_while_recruiting
Last update:2020-07-14, 1399/04/24
Update count:0
Registration date
2020-07-14, 1399/04/24
Registrant information
Name
Davood Arab
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 4042
Email address
drdavoodarab@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-03, 1399/03/14
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the clinical efficacy of Intravenous Fentanyl and Ketorolac in relieving renal colic pain
Public title
Comparison between the clinical efficacy of Intravenous Fentanyl and Ketorolac in relieving renal colic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of unilateral abdominal or flank pain that the treating emergency physicians suspect to be renal colic
Ultrasonography or CT Scan or intravenous pyelography (IVP) findings consistent with the diagnosis of renal stone
Stone excretion
Exclusion criteria:
Visual Analog Scale (VAS)≤3
History of peptic ulcer disease
History of asthma
History of bleeding disorder
Using of oral anticoagulant
Impaired renal or hepatic function
Hypersensitivity to Aspirin or NSAID or Fentanyl
Pregnant and breast-feeding women
Received Sedative,Antipsychotic,MAO-I, painkillers within 6 hours before
Younger than 18 and greater than 55 years old
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be examined after obtaining a diagnosis and demographic information. Eligible patients entering the study are randomly divided into two groups by permuted balanced block randomization. And the randomization list will be prepared using block stratified randomization software for windows version 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is designed as single blind and only patients were blind in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Kosar Hospital,Bassije Blvd,Semnan,Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.SEMUMS.REC.1399.067
Health conditions studied
1
Description of health condition studied
Acute Renal Colic
ICD-10 code
Calculus o
ICD-10 code description
N20.2
Primary outcomes
1
Description
Pain level
Timepoint
Before treatment initiation and sequentially at 20, 40, 60 minutes
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
heart rate
Timepoint
Before treatment initiation and sequentially at 20, 40, 60 minutes
Method of measurement
Radial puls
2
Description
Blood pressure
Timepoint
Before treatment initiation and sequentially at 20, 40, 60 minutes
Method of measurement
Sphygmomanometer
3
Description
Body temperature
Timepoint
Before treatment initiation and sequentially at 20, 40, 60 minutes
Method of measurement
Thermometer(axillary)
4
Description
Respiratory rate
Timepoint
Before treatment initiation and sequentially at 20, 40, 60 minutes
Method of measurement
Physical exam
5
Description
Fentanyl side effects
Timepoint
In all the time in care
Method of measurement
Questionnaire and physical examination
6
Description
Ketorolac side effect
Timepoint
In all the time in care
Method of measurement
Questionnaire and physical examination
Intervention groups
1
Description
Intervention group 1: patients will receive 0.1mg intravenous Fentanyl (Darou Pakhsh Pharmaceutical company) infused in 100 ml normal saline within 10 minutes.
Category
Treatment - Drugs
2
Description
Intervention group 2: patients will receive 30mg intravenous Ketorolac(Alborz Darou Pharmaceutical company) within 15 seconds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Medical Center
Full name of responsible person
Dr Davood Arab
Street address
Kosar Hospital, Bassij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7830
Fax
+98 23 3343 7837
Email
drdavoodarab@semums.ac.ir
Web page address
https://kosarhos.semums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Parviz Kokhaie
Street address
Semnan University of Medical Sciences, Bassij Blvd., Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
rds@semums.ac.ir
Web page address
https://rtvc.semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Davood Arab
Position
fellowship of Endourology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Kosar Hospital, Bassij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7830
Fax
+98 23 3343 7837
Email
drdavoodarab@semums.ac.ir
Web page address
http://kosarhos.semums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Davood Arab
Position
Fellowship of Endourology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Kosar Hospital, Bassij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7830
Fax
+98 23 3343 7837
Email
drdavoodarab@semums.ac.ir
Web page address
https://kosarhos.semums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Davood Arab
Position
fellowship of Endourology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Kosar Hospital, Bassij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7830
Fax
+98 23 3343 7837
Email
dadavoodarab@semums.ac.ir
Web page address
https://kosarhos.semums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)