Protocol summary

Summary
This study is a single blind randomized clinical trial to compare the effects on pain and morphine, fentanyl pain in patients with femoral shaft fractures were admitted to the emergency. Inclusion criteria: patients with femur fractures, one-sided, single and classification of 1 or 2 ASA; patients 18 to 55 years of both sexes; a maximum of 20 minutes after arrival to the emergency department trauma. Exclusion criteria were: decreased level of consciousness (GCS less than 14) and neural tube defects (FND); respiratory depression, hypotension (systolic blood pressure <90) and generally patients with hemodynamically unstable; multiple trauma (injury to intra-abdominal organs, bleeding Notably, head trauma); Tyad to drugs. Patients in group 1 (35 patients receiving 1.0 mg kg intravenous morphine sulfate with distilled water to a final volume reached 10 ml) and group 2 (35 patients, 5.1 mg kg group receiving fentanyl intravenous (12)) are. Two groups of patients before and after injection (0), 15 minutes and 30 minutes after treatment by visual analogue scale (Visual Analog Scale- VAS) are evaluated, as well as possible side effects and vital signs (blood pressure systolic and diastolic, heart rate and respiratory rate, body temperature) and arterial oxygen saturation, as well as in patients by Czech list has been prepared for this purpose, is recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016053028171N1
Registration date: 2016-09-18, 1395/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-18, 1395/06/28
Registrant information
Name
Mohsen Tabatabaei
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86334172517
Email address
smt.tabatabai@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor University of Medical Sciences
Expected recruitment start date
2014-10-15, 1393/07/23
Expected recruitment end date
2016-03-13, 1394/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of Morphine versus Fentanyl in isolated closed femor fracture in trauma patients
Public title
Comparison of analgesic effect of Morphine versus Fentanyl in isolated closed femor fracture in trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with femur fractures, one-sided, single and classification of 1 or 2 ASA; patients 18 to 55 years of both sexes; a maximum of 20 minutes after arrival to the emergency department trauma. Exclusion criteria were: decreased level of consciousness (GCS less than 14) and neural tube defects (FND); respiratory depression, hypotension (systolic blood pressure <90) and generally patients with hemodynamically unstable; multiple trauma (injury to intra-abdominal organs, bleeding Notably, head trauma); Tyad to drugs.
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: 70
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
Ethics committee of Arak University of Medical Sciences
Street address
St. Alamolhoda,St. Maskan, Arak
City
Arak
Postal code
Approval date
2014-10-15, 1393/07/23
Ethics committee reference number
22-169-93

Health conditions studied

1

Description of health condition studied
femor fracture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Before and after injection (0), 15 minutes and 30 minutes after taking drugs.
Method of measurement
Sphygmomanometer

2

Description
Diastolic blood pressure
Timepoint
Before and after injection (0), 15 minutes and 30 minutes after taking drugs.
Method of measurement
Sphygmomanometer

Secondary outcomes

1

Description
heart beat
Timepoint
Before and after injection (0), 15 minutes and 30 minutes after taking drugs.
Method of measurement
ECG

Intervention groups

1

Description
Intervention group 1:35 patients receiving 1.0 mg kg intravenous morphine sulfate that has been distilled water to a final volume of 10 ml.
Category
Treatment - Drugs

2

Description
Intervention group 2: 35 patients in the group receiving 5.1 micrograms per kilogram of Fentanyl are.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital Arak
Full name of responsible person
Dr. tabatabaei Mohsen
Street address
Valiasr Hospital Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Arak, School of Medicine
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Arak 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
Arak University of Medical sceinces
Full name of responsible person
Dr. tabatabaei Mohsen
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Arak, Vali Asr Hospital
City
Arak
Postal code
Phone
+98 86 3313 7550
Fax
Email
smt.tabatabai@arakmu.ac.ir; rahenorayaneh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. tabatabaei mohsen
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Valiasr Hospital Arak
City
Arak
Postal code
Phone
+86 32222003
Fax
Email
smt.tabatabai@arakmu.ac.ir; rahenorayaneh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. tabatabaei Mohsen
Position
Emergency medicine specialist
Other areas of specialty/work
Street address
Valiasr Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3313 4715
Fax
Email
smt.tabatabai@arakmu.ac.ir; rahenorayaneh@yahoo.com
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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