Study objective: To evaluate the clinical efficacy of intravenous acetaminophen in lowering the dose of morphine in renal colic in Imam Reza (AS) Educational-Therapeutic Center of Tabriz University of Medical Sciences;
Design of study: randomized, single blind, not-placebo controlled, single center trial;
Inclusion criteria: patients 18-50 years old; known case of kidney stone.
Exclusion criteria: using any drug for pain prior to attendance; allergy to the administered medications; history of opioid dependence; hypertension; fever and chills ; pregnancy and pain intolerance during the first 35 min of drug administration;
Sample size: 100 divided in Two Groups Including intravenous 1 gram acetaminophen with Low Dose Morphine in Intervention Group vs. Intravenous 1mg/kg of morphine in control group;
Duration of Intervention: 35 minutes;
The effect of two drugs is evaluated based on pain intensity VAS system in minutes 0, 1, 5, 10, 15, 25 and 35 after Administration.
General information
Acronym
rss
IRCT registration information
IRCT registration number:IRCT2013071411555N1
Registration date:2014-05-17, 1393/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-17, 1393/02/27
Registrant information
Name
Hamidreza Mortezabeigi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2078
Email address
mortezabaghih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Apotel (intravenous acetaminophen) with intravenous morphine in patients with acute renal colic
Public title
Evaluation of the effect of intravenous acetaminophen in lowering the dose of morphine in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients 18-50 years old; known case of kidney stone.
Exclusion criteria: using any drug for pain prior to attendance;, allergy to the administered medications; history of opioid dependence; hypertension; fever and chills ; pregnancy and pain intolerance during the first 35 min of drug administration; pain intolerance during the first 35 min of drug administration.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committe of Tabriz University of medical Sciences
Street address
Tabriz University, Medical Sciences Building
City
Tabriz
Postal code
Approval date
2013-06-12, 1392/03/22
Ethics committee reference number
9243
Health conditions studied
1
Description of health condition studied
renal colic
ICD-10 code
n20,n21,n2
ICD-10 code description
Calculus of kidney and ureter which can cause colicy pain
Primary outcomes
1
Description
pain severity
Timepoint
0, 1, 5, 10, 15, 25 and 35 min after drug administered
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
probable complications
Timepoint
during procedure until 1 week after discharge
Method of measurement
according to history and physical examination
Intervention groups
1
Description
In intervention group, which the sample will be selected randomly out of 100 patients admitted with acute renal colic, 1 gram of Intravenous Acetaminophen (Apotel) combined with a low dose of Morphine will be administered.
Category
Treatment - Drugs
2
Description
In Control group, which will be selected randomly from the population of 100 patients admitted with acute renal colic, morphine will be administered intravenously with the dose of 0.1 mg/kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Imam Reza (AS) Educational-Therapeutic Centre
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamidreza Mortezabeigi
Street address
Emergency department of Imam Reza (AS) Educational-Therapeutic Centre
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamidreza Mortezabegi
Position
Specialty-assitant professor
Other areas of specialty/work
Street address
Golgasht Street, Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
Email
mortezabaghih@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hamidreza Morteza Beigi
Position
Speciality-Assistant professor
Other areas of specialty/work
Street address
Golgasht Street, Imam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
Email
mortezabaghih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Speciality-Assistant professor
Full name of responsible person
Dr Hamidreza Mortezabeigi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)