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The Efficacy of intranasal desmopressin with Intramuscular sodium diclofenac in comparison with Intramuscular sodium diclofenac alone in acute renal colic

Protocol summary

Summary
Pain is the most common presenting complaint in patients who present to the Emergency Department (ED). Renal colic pain is probably the worst excruciatingly painful event a person can endure. It has been suggested that desmopressin helps to relieve the pain of renal colic immediately. Because of low cost, ease of administration and low adverse effects of desmopressin comparison with opioids and NSAIDs, this study was conducted.The patients 18-55 years old with clinical diagnosis of renal colic were included. The presence of the nephrolithiasis had been approved in all patients in the past or confirmed in later follow up. In a double-blind, clinical trial in the ED of Imam Khomeini Hospital, Ahvaz, Iran, If patients had no exclusion criteria were randomly divided into two different treatment groups (n=120, 60 in each group). Group A received 40 μg of intranasal desmopressin, equal to 4 puffs of available products, combined with 75 mg intramuscular sodium diclofenac. Group B received 75 mg intramuscular sodium with 4 puff of intranasal placebo spray. A visual analog scale (VAS) score from 0-10, at baseline, 15, 30, 45 and 60 minutes of drug administration was utilized to assess the severity of pain. At 30 min, morphin sulfate 5 mg was injected if pain score ≥5. Ultimately at 60 min, morphine sulfate 5 mg intravenously injected again if any degree of pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138809082782N1
Registration date: 2014-06-06, 1393/03/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-06, 1393/03/16
Registrant information
Name
Kambiz Masoumi
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 9166
Email address
kami_masoumi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2014-05-16, 1393/02/26
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of intranasal desmopressin with Intramuscular sodium diclofenac in comparison with Intramuscular sodium diclofenac alone in acute renal colic
Public title
Intranasal Desmopressin spray efficacy in acute renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-55 years old ; clinical diagnosis of acute renal colic Exclusion criteria: hypertension ; coronary artery disease ; rhinitis ; influenza ; coagulopathy ; anticoagulant therapy ; peptic ulcer disease ; asthma, kidney failure ; liver failure ; pregnancy ; use of analgesics within 4 hours and Alpha blockers before admission ; addiction to drugs ; surgery on the kidney or ureter ; and fluids therapy immediately before admission ; unbearable pain ; refusion of patients of any cause
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
It & research assistance centre, University complex
City
Ahvaz
Postal code
Approval date
2011-10-01, 1390/07/09
Ethics committee reference number
ETH-359

Health conditions studied

1

Description of health condition studied
renal colic
ICD-10 code
N23
ICD-10 code description

Primary outcomes

1

Description
Pain severity score
Timepoint
Before intervention and at 15, 30, 45 and 60 minutes after intervention
Method of measurement
Visual analuge scale

Secondary outcomes

empty

Intervention groups

1

Description
40 microgram Desmopressin spray intranasal (4 puff)l with 75 mg sodium diclofenac intramuscular
Category
Treatment - Drugs

2

Description
75 mg sodium diclofenac intramuscular with 4 puff NACL 0.65% intranasal spary
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Kambiz Masoumi
Street address
Emergency Department, Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Nader Saki, Deputy of research in university
Street address
IT & research centre, University complex
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical ScienceS
Full name of responsible person
Kambiz Masoumi
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Department of Emergency Medicine, Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 9166
Fax
Email
kami_masoumi@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Kambiz Masoumi
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Department of Emergency Medicine, Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 1965
Fax
Email
kami_masoumi@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Kambiz Masoumi
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Department of Emergency Medicine, Imam Khomeini Hospital, Azadegan Ave
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 1965
Fax
Email
kami_masoumi@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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