Clinical trial of efficacy comparison of intranasal desmopressin vs.intravenous ketorolac in patients with renal colic referring to emergency department
(1) Objectives: Comparison of intranasal desmopressin and Intravenous Ketorolac for pain management in renal colic patients
(2) Design: Double-blind randomized clinical trial
(3) Setting and conduct: 40 patients randomly divided to 2 groups. One group receiving intranasal desmopressin and intravenous normal saline and in other group, intravenous ketorolac and intranasal normal saline was administered.
(4) Participants: 16-50 years old patients with renal colic referring to emergency department without history of sensitivity to desmopressin and ketorolac, history of cardiac disease, hypertension, pregnancy and breast feeding, analgesic consumption within 4 hours of admission
(5) Intervention: 40 micro grams intranasal desmopressin and 1cc intravenous normal saline have been given to desmopressin group and 30mg intravenous ketorolac and 4 puffs of nasal normal saline was given to ketorolac group.
(6) Main outcome measures: Pain score was assessed with visual analogue scale prior to drug administration and 10, 30 and 60 minutes after that
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040527235N1
Registration date:2016-10-23, 1395/08/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Kambiz Nasiri
Name of organization / entity
Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 936 702 3703
Email address
kambiznasiry@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti Medical University
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of efficacy comparison of intranasal desmopressin vs.intravenous ketorolac in patients with renal colic referring to emergency department
Public title
Desmopressin effect on pain management of kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with impression of renal colic; 16-50 years old
Exclusion criteria:History of sensitivity to desmopressin and ketorolac; history of cardiac disease; hypertension; analgesic consumption within 4 hours of admission; pregnancy; breast feeding; hepatic or renal failure
Age
From 16 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization using table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Shahid Beheshti University of Medical Sciences
Street address
Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Velenjak Street
City
Tehran
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
Ir.sbmu.msp.rec.1395.79
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 intervention, 10,30,60 minutes after intervention
Method of measurement
Pain score based on visual analouge scale
Secondary outcomes
1
Description
Side effects
Timepoint
from starting drug administration until 1 hours after
Method of measurement
Serial physical exam
Intervention groups
1
Description
Intervention group: 40 micro grams intranasal desmopressin and 1 cc intravenous normal saline were administered once.
Category
Treatment - Drugs
2
Description
Control group: 30mg IV ketorolac and 4 puff of intranasal normal saline were administered once.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Kambiz Nasiri
Street address
Shahid Madani Street
City
Tehran
2
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Kambiz Nasiri
Street address
Qazvin Street
City
Tehran
3
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Kambiz Nasiri
Street address
Shahrdari Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research shahid Beheshti university of medical science
Full name of responsible person
Seyed Ali Ziyayi
Street address
Vice chancellor for research, 3rd floor, Medical School, Shahid Beheshti University of Medical Sciences, Velenjak, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research shahid Beheshti university of medical science