The main purpose in the treatment of renal colic patients in emergency department is pain management. This study aimed to compare the analgesic effect of intravenous (IV) acetaminophen and morphine sulfate in this regard. This double blind clinical trial was renal colic patients in need of pain management in emergency department. The pain severity before and 15, 30, 60, and 120 minutes after injection as well as side effects were compared between IV acetaminophen and morphine sulfate groups using SPSS 16.In this study, doctors and patients were not aware of the type of medication used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080835565N1
Registration date:2017-08-14, 1396/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-14, 1396/05/23
Registrant information
Name
hossein montazer
Name of organization / entity
Mazandaran university of medical siences
Country
Iran (Islamic Republic of)
Phone
+98 11 3448 4859
Email address
hmontazer@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravenous Acetaminophen versus Morphine Sulfate in Pain Management of Acute Renal Colic; a Randomized Clinical Trial
Public title
Intravenous Acetaminophen versus Morphine Sulfate in Pain Management of Acute Renal Colic; a Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with renal colic , age between 18 -55 years old
Exclusion criteria: allergy to morphine and paracetamol , fever , pregnant , history of addiction , instability of vital signs , liver function disease , renal function disease , renal transplant
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:
355
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Available sampling
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Jooybar treeway, Imam Square
City
Sari
Postal code
4815724971
Approval date
2015-02-28, 1393/12/09
Ethics committee reference number
13/12/1393
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
analgesia after drug infusion
Timepoint
0,15,30,60,120 after intervention
Method of measurement
visual analog scale device
Secondary outcomes
1
Description
vertigo,vomiting
Timepoint
0,15,30,60,120 after intervention
Method of measurement
Observation
Intervention groups
1
Description
intervention group: 1gr of IV acetaminophen manufactured by Exir Company, Iran in 100 ml of normal saline and duration of infusion is15 minutes
control group:0.1mg/kg intravenous (IV) morphine, manufactured by Darou Paksh Company, Iran, in 100ml of normal saline and duration of infusion is15 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeni Hospital
Full name of responsible person
hossein montazer
Street address
Amir mazandarani Bolivard
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for researche, Mazandaran University of Medical Siences
Full name of responsible person
Ahmadali Enayati
Street address
Vice chancellor for researche, Mazandaran University of Medical Siences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for researche, Mazandaran University of Medical Siences