To compare the effect of nebulized Fentanyl versus intravenous Ketorolac in patients with renal colic
Design
This is a double-blind randomized clinical trial, phase II, in which 186 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with renal colic who will refer to Besat Hospital in Hamadan City during the study period will be enrolled in the trial and will be randomly assigned to the intervention 1 and 2 groups. This trial will be double-blinded so that neither patients nor the physician who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 12 to 80 years
Renal colic
Exclusion criteria:
Unstable hemodynamic
Body temperature above 38 degrees centigrade
Acute abdomen
Heart failure and ischemic heart disease
Renal failure
Liver failure
History of transplantation
Pregnancy
Intervention groups
Intervention group 1:
Nebulized Fentanyl 50 mcg as a single dose
Intervention group 2:
Intravenous Ketorolac 0.9 mg/kg as a single dose
Main outcome variables
Assessing renal pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N273
Registration date:2019-05-04, 1398/02/14
Registration timing:retrospective
Last update:2019-05-04, 1398/02/14
Update count:0
Registration date
2019-05-04, 1398/02/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2019-04-17, 1398/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of nebulized Fentanyl versus intravenous Ketorolac in patients with renal colic: a double-blind randomized clinical trial
Public title
Comparison of the effect of nebulized Fentanyl versus intravenous Ketorolac in patients with renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 12 to 80 years
Renal colic
Exclusion criteria:
Unstable hemodynamic
Body temperature above 38 degree centigrade
Acute abdomen
Heart failure and ischemic heart disease
Renal failure
Liver failure
A history of transplantation
Pregnancy
Age
From 12 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
186
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to the intervention 1 group or intervention 2 group using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention 1 and on the other two sheets the name of the intervention 2. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as triple blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
IR.UMSHA.REC.1396.889
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
Assessing the renal pain
Timepoint
Every 15 minutes for 2 hours
Method of measurement
Using Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group 1: Nebulized Fentanyl 50 mcg as a single dose
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous Ketorolac 0.9 mg/kg as a single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan City
Full name of responsible person
Dr. Alireza Kalantari
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
alirezakalantari1362@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Kalantari
Position
Resident of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
alirezakalantari1362@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Barza Rezaei
Position
Emergency Medicine Specialist
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
bareza49@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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