Comparison of intranasal and intravenous fentanyl to control acute renal colic pain in emergency department
Design
In this study, 120 patients who referred to the Emergency Department with symptoms of acute renal pains are included in the study. Participants are divided into two groups in terms of drug use. To balance the two groups, the minimization method is used.
Settings and conduct
This is the multicenter study will be done in Kerman, southeastern Iran. By minimization, patients are divided into two groups. A group will receive intravenous fentanyl and intramuscular ketorolac and the second group intranasal fentanyl and intramuscular ketorolac.The nurse will prescribe medication and determine the type of medication prescribed by the physician. Data collection will be done by another physician.
Participants/Inclusion and exclusion criteria
All patients with acute renal colic symptoms aged 16 to 65 years are included in the study, and patients who have a possible other diagnosis or have a drug allergy or organ failure and kidney transplantation are excluded.
Intervention groups
One group received fentanyl intravenous (1micro/kg) and intramuscular ketorolac (30 mg IM) and the second group received intranasal fentanyl (3 micro/kg) and intramuscular ketorolac (30 mg IM).
Main outcome variables
Procedural time, pain stop time, patient and physician satisfaction, side effects of the drug, the need for more doses of the drug, recurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150509022181N4
Registration date:2019-06-19, 1398/03/29
Registration timing:registered_while_recruiting
Last update:2019-06-19, 1398/03/29
Update count:0
Registration date
2019-06-19, 1398/03/29
Registrant information
Name
Mehdi Torabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 199 2016
Email address
mtorabi1390@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Atomized intranasal vs intravenous fentanyl for acute Renal colic management in ED: A randomized double-blinded clinical trial
Public title
Atomized intranasal vs intravenous fentanyl for acute Renal colic management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
16-65 years old
clinical symptoms of acute renal colic
visual analog scale (VAS) greater than or equal to 7
Exclusion criteria:
allergy to opiates and NSAIDs
known or suspected abdominal aortic dissection or aneurism
peritonitis
hemodynamic instability
pregnancy, breastfeeding
anticoagulant therapy
organs failure
renal transplantation
Age
From 16 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomized by minimization to a 1:1 ratio to receive either intranasal or intravenous fentanyl in a double-blinded fashion (physician and analyzer). Patients with pain intensity are divided according to VAS, which is not significantly different between the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The physician for data collection and data analyzer are blinded about 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 Kerman University of Medical Science
Street address
Gharani Ave, Bahonar academic hospital
City
Kerman
Province
Kerman
Postal code
7619736555
Approval date
2018-12-27, 1397/10/06
Ethics committee reference number
IR.KMU.AH.REC.1397.116
Health conditions studied
1
Description of health condition studied
Acute renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
Pain control time
Timepoint
At the beginning of the study, 10, 20, 30, 40, 60 minutes after the administration of the drug
Method of measurement
VAS (Visual Analog Scale)
Secondary outcomes
1
Description
The physician and patient satisfaction
Timepoint
The end of study
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: In the intervention group, fentanyl was administered intranasally with intravenous placebo. Fentanyl, a sublimaz brand, was prescribed at a dose of 1 microgram per kilogram.
Category
Treatment - Drugs
2
Description
Control group: The control group received placebo intranasally with intravenous fentanyl. Fentanyl, a sublimaz brand, was prescribed at a dose of 1 microgram per kilogram.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar academic hospital
Full name of responsible person
Mehdi Torabi
Street address
Gharani ave.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mtorabi1390@yahoo.com
2
Recruitment center
Name of recruitment center
Afzalipour academic hospital
Full name of responsible person
Mehdi Torabi
Street address
Emam Blvd.
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
mtorabi1390@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Ebnesina Ave.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
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
Mehdi Torabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Gharani Ave.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mtorabi1390@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Torabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Gharani Ave.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 32235011
Email
mtorabi1390@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Torabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Gharani Ave.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mtorabi1390@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual and outcome data will be provided
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Academic Institutions
Under which criteria data/document could be used
Clinical research
From where data/document is obtainable
email
What processes are involved for a request to access data/document
Two weeks after receiving the request email, the results will be e-mailed.