Protocol summary

Summary
We complete a randomized, double-blind study over 50 trauma patients who have isolated diaphysial long bone fracture in emergency department of Hasheminejad hospital in Mashhad, Iran. Inclusion criteria are the age between 15 and 60 years old; isolated diaphysial long bone fracture without decrease level of consciousness and without any other painful lesion. Participants are offered verbal information about the study as well as a written information sheet. Written informed consent is then obtained. The baseline data collected are: name, sex, age, body weight and the type of the fracture. Adverse reactions are recorded also at the end. Then one of two drugs-morphine sulfate or intravenous acetaminophen is chosen by the randomized block method for any patient. Before administration of chosen drug, our colleague (who is not aware of which drug has been chosen) asks the patient to determine his or her pain severity on the visual analogue scale. It should be noted the patient does not know that which drug has been chosen. Then the patient in morphine sulfate group receives 0.1 mg /kg of intravenous morphine sulfate by researcher. Again the researcher’s colleague asks the patient to determine the pain level based on visual analogue scale 5 and 30 minutes after drug administration. Similarly the patient in acetaminophen group receives 15 mg /kg of intravenous acetaminophen by researcher and is asked by researcher’s colleague to determine the pain severity based on visual analogue scale 5 and 30 minutes after injection. Finally, data will be compared and analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012123111956N1
Registration date: 2014-11-12, 1393/08/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-12, 1393/08/21
Registrant information
Name
Morteza Talebi Doluee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
talebidm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between analgesic effect of intravenous acetaminophen vs intravenous morphine sulfate for isolated diaphysial long bone fractures
Public title
A comparison between analgesic effect of intravenous acetaminophen vs intravenous morphine sulfate for bone fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: dyaphisial fracture of long bone; no decrease level of consciousness; age between 15 to 60 years old. Exclusion criteria: decrease level of consciousness; any history of renal or hepatic disease; any other painfull lesion; any history of opium addiction.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Mashhad University of Medical Sciences
Street address
Ethics Committee, Ghoreishi building, Daneshgah ave.
City
Mashhad
Postal code
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
910391

Health conditions studied

1

Description of health condition studied
Long bone fracture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain decrease
Timepoint
Before analgesic administration and 5 and 30 minutes after analgesic administration
Method of measurement
Visual analoge scale

Secondary outcomes

1

Description
Nausea and vomiting
Timepoint
30 minutes after analgesic administration
Method of measurement
Questionnaire

Intervention groups

1

Description
We administer intravenous acetaminophen 15 mg/kg for the first group of patients with long bone fracture.
Category
Treatment - Drugs

2

Description
We administer morphine sulfate 0.1 mg/kg for second group of patients.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Hasheminejad hospital
Full name of responsible person
Dr Morteza Talebi, emergency medicine specialist
Street address
Aboureyhan bolv.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
vice chancellor of research, Dr. Mohsen Tafaghodi
Street address
Vice chancellor of research, Ghoreishi building, Daneshgah ave.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Siences
Full name of responsible person
Dr. Bahram Zarmehri
Position
MD, resident of emergency medicine
Other areas of specialty/work
Street address
Department of emergency medicine, Emam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
zarmehrib901@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Emergency Medicine, Mashhad University of Medical Siences
Full name of responsible person
Dr. Morteza Talebi
Position
Emergency medicine specialist, assistant professor of emergency medicine
Other areas of specialty/work
Street address
Department of emergency medicine, Emam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
talebimd@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Siences
Full name of responsible person
Dr. Morteza Talebi
Position
Assistant professor of emergency medicine
Other areas of specialty/work
Street address
Department of emergency medicine, Emam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
talebidm@mums.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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