Renal colic is one the main painful situations which brings the patients to emergency department and proper management of renal colic pain is an important task for every emergency medicine physician. There are some evidence that shows intranasal desmopressin may be efficient for renal colic pain management, however the studies which had been done so far has limitations, among them one of the most important limitation is small sample size. In the present study we are going to compare efficacy of intranasal desmopressin with intravenous acetaminophen in renal colic pain relief. 300 patients with primary diagnosis of renal colic who would be admitted to Rasoul Akram and Sina hospital will be randomly divided into two groups of 150 patients. One group will receive 40 micro gr of intranasal desmopressin and the other will receive 15 mg/kg of intravenous Acetaminophen with maximum dose of 1000 mg. Patients' pain score will be assessed at minutes 0, 15, 30, and 60 by means of a visual analog scale which is a 10 cm scale in which 0 means no pain and 10 means maximum level of pain. If the patient's pain is not controlled after 30 minutes he will receive intravenous Morphine until the pain would be relieved. The mean of pain severity score at minutes 0, 15, 30, 60 and dosage of morphine used in each group will be compared. After 24 hours and then 1 week later we assess patients for any possible morbidity and stone passage. These outcomes will be also compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101510017N4
Registration date:2013-04-29, 1392/02/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-29, 1392/02/09
Registrant information
Name
Hamed Basir Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
h-basirghafouri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between intranasal Desmopressin and intravenous Acetaminophen in renal colic pain management
Public title
Effect of intranasal Desmopressin in renal colic pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients with renal colic impression on diagnosis.
Exclusion criteria: patients for whom another diagnosis would be established rather than renal colic; analgesic use 4 hours before admission; opium addiction; any kind of renal, hepatic or infectious disease; pregnancy.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Tehran University of medical sciences
Street address
Headquarter for Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-06-05, 1391/03/16
Ethics committee reference number
271/ 130/د/91
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 severity
Timepoint
Before intervention and 15, 30, 60 min after intervention
Method of measurement
Visual analog pain scale
Secondary outcomes
1
Description
Final mortality and morbidity
Timepoint
24 hours and one week after intervention
Method of measurement
Asking by phone
Intervention groups
1
Description
Control group: 15 mg/kg of intravenous Acetaminophen with maximum dose of 1000 mg as a single dose.
Category
Treatment - Drugs
2
Description
Intervention group: 40 micro gr of intranasal desmopressin as a single dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Hamed Basir Ghafouri
Street address
Hasan Abad sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhundzadeh
Street address
Keshavarz Blvd. Pour Sna street.Tehran University of Medical Siences, School of Medicine .first floor .No303
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science, School of Medicine
Full name of responsible person
Dr Hamed Basir Ghafouri
Position
MD, Emergency Medicine Specialist
Other areas of specialty/work
Street address
Satarkhan street, Niayesh sreet, Rasoul-Akram Hospital,Emergency Department
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
h-basirghafouri@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Hamed Basir Ghafouri
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Satarkhan street, Niayesh sreet, Rasoul-Akram Hospital,Emergency Department
City
Tehran
Postal code
Phone
+98 21 6652 5327
Fax
Email
h-basirghafouri@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Science, School of Medicine
Full name of responsible person
Dr Hamed Basir Ghafouri
Position
MD, Emergency Medicine Specialist
Other areas of specialty/work
Street address
Satarkhan street, Niayesh sreet, Rasoul-Akram Hospital,Emergency Department
City
Tehran
Postal code
Phone
+98 21 6641 8466
Fax
Email
h-basirghafouri@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)