Rib fracture is one of the common causes of trauma disabilities in many events and the outcome of these patients are very extensive. Control and
management of the pain in such patients is one of the most important challenges in emergency departments. In this double-blind study, 54 patients over 18 years of age, referred to Alzahra educational hospital with rib fracture, were entered. Patients were randomly categorized in two groups of morphine sulfate (0.1
milligram per kilogram of body weight) and IV acetaminophen (1gram), as single-dose
infused in 100 cc normal saline. The pain severity was measured by Numeric Rating Scale on arrival and 30 minutes after drug administration. At least three scores reduction was reported as therapeutic success.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042812072N2
Registration date:2015-05-24, 1394/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-24, 1394/03/03
Registrant information
Name
Mehrdad Esmailian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 3482
Email address
m_esmailian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Analgesic Effect of Intravenous Acetaminophen and
Morphine Sulfate in Rib Fracture
Public title
Analgesic Effect of Morphine and Acetaminophen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
one or two rib fractures confirmed by chest radiography;
normal level of con-sciousness (Glasgow Coma scale of 15);
weight range be-tween 60-100 kilogram;
pain score>4 centimeters based on Numeric Rating Scale;
Exclusion criteria :
background pulmonary problems;
history of taking analgesic or opioid drugs;
addiction;
history of liver or kidney diseases;
head trauma; pregnancy;
respiratory arrest on arriva;l
repeated vomiting and nausea
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Isfahan University of Medical sciences
Street address
Azadi Ave.
City
Isfahan
Postal code
Approval date
2012-09-05, 1391/06/15
Ethics committee reference number
54561
Health conditions studied
1
Description of health condition studied
Rib fracture
ICD-10 code
S22.3
ICD-10 code description
Fracture of rib
Primary outcomes
1
Description
pain accuity
Timepoint
at start and 30 minute after intervention
Method of measurement
Numeric Rating Scale
Secondary outcomes
1
Description
vital signs
Timepoint
at start and 30 minute after intervention
Method of measurement
manomter and pulse checking
2
Description
O2 saturation
Timepoint
at start and 30 minute after intervention
Method of measurement
PulseOxymtery
3
Description
Drug Complications
Timepoint
at start and 30 minute after intervention
Method of measurement
History and physical examination
Intervention groups
1
Description
Intervention group treat with IV acetaminophen (1gram per kilogram of body weight, single-dose, and infused in 100 cc normal saline). If the pain will not relieved after the first 30 minutes, a rescue dose of morphine will inject by a trained physician, considered as a treatment failure.
Category
Treatment - Drugs
2
Description
Control group treat with morphine sulfate (0.1 milligram per kilogram of body weight, single-dose, and infuse in 100 cc normal saline). If the pain will not relieved after the first 30 minutes, a rescue dose of morphine will inject by a trained physician, considered as a treatment failure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mehrdad esmailian
Street address
Sofeh Blv.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Reza Azizkhani
Street address
Azadi Ave.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Azadi Ave.
City
Isfahan
Postal code
Phone
+98 31 3629 3482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Assistant Professor of Emergency medicine
Other areas of specialty/work
Street address
Azadi Ave.
City
Isfahan
Postal code
Phone
+98 31 3629 3482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mehrdad Esmailian
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Azadi ave.
City
Isfahan
Postal code
Phone
+31 36293482
Fax
Email
m_esmailian@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)