Study objective: To compare the clinical effectiveness of intravenous morphine and acetaminophen on renal colic in Golestan Hospital, Ahwaz, Iran. Design of study: randomized, double blind, non-placebo controlled, single center trial. Inclusion criteria: patients 18-55 years old; known case of kidney stone. Exclusion criteria: any drug allergy to morphine and acetaminophen; hemodynamic instability; fever more than 38°c; any evidence of peritoneal inflammation; pregnancy or suspected pregnancy; aortic aneurysm or proven or suspected Dissection. Sample size: 108. Intervention: 1 gram of intravenous acetaminophen in the intervention group vs. injection of 1mg/kg of morphine in control group. The effect of two drugs is evaluated based on pain intensity VAS system in minutes 0, 15, 30, 45 and 60.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202279150N1
Registration date:2012-03-21, 1391/01/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-21, 1391/01/02
Registrant information
Name
Mohammad Manouchehri Far
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3079
Email address
manouchehrifar-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur university of medical sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Clinical Efficacy of Intravenous Morphine with Acetaminophen in Renal Colic
Public title
Acetaminophen compared with morphine in renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients 18-55 years old; known case of kidney stone. Exclusion criteria: Any drug sensitivity to morphine and Acetaminophen; hemodynamic instability; fever more than 38°C; any evidence of peritoneal inflammation; pregnancy or suspected pregnancy; aortic aneurysm or proven or suspected Dissection; the use of any drug for pain up to 6 hours prior to the emergency room; patients with heart failure, kidney and lung disease; patients with liver failure and kidney transplant patients and patients with drug addiction.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundishapur university of medical sciences
Street address
Ahwaz Jundishapur university of medical sciences
City
Ahwaz
Postal code
Approval date
2012-01-09, 1390/10/19
Ethics committee reference number
ETH-368
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
minutes 0, 15, 30, 45 and 60.
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1 : intravenous of 1 g of acetaminophen in 100 cc of saline
Category
Treatment - Drugs
2
Description
Intervention 2 : 0.1 mg/kg of morphine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundishapur university of medical sciences
Full name of responsible person
Mohammad Alavi M.D.
Street address
Ahwaz Jundishapur university of medical sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz 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 University of Medical Sciences
Full name of responsible person
Dr. Ali Khavanin
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
No. 76, West Esfand, Kianpars
City
Ahwaz
Postal code
Phone
+98 61 1374 3079
Fax
+98 61 1374 3079
Email
akhavanin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Manouchehri Far
Position
Specialist in emergency medicine
Other areas of specialty/work
Street address
Office of Emergency Medicine, Golestan Hospital
City
Ahwaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
manouchehrifar-m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Manouchehri Far
Position
Specialist in emergency medicine
Other areas of specialty/work
Street address
Office of Emergency Medicine, Golestan Hospital
City
Ahwaz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)