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Comparing the efficacy and adverse effects of oxycodone and morphine sulfate in isolated limb trauma patients, admitted to emergency department of Imam Khomeini hospital, between 2011 and 2012 period

Protocol summary

Summary
To compare the efficacy of oxycodone and morphine sulfate a double blinded, randomized, clinical trial study will be done. After obtaining informed consent, forty adult patients with acute lower limb trauma who are eligible for this study will be randomized to two groups. The control group will receive 5 milligrams of morphine sulfate intravenous injection and placebo tablet and the intervention group will receive 5 milligrams oxycodone hydrochloride tablet and placebo injection. Pain severity will be assessed by NRS (Numerical pain Rating Scale) scoring system. At times 0, 30' , 60' of analgesic administration pain severity, vital signs and adverse effects of analgesics such as lethargy, nausea, vomiting and itching will be assessed and registered in data collection sheets. All patients older than 14 years old with acute lower limb trauma who are admitted to Emergency department of Imam Hospital could be eligible for study however patients with past history of allergy to opioid, chronic renal/respiratory/liver disease, recent use of opioid, altered mental state, head trauma and pregnant patients will be excluded from study. SPSS software will be used for data analysis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204089387N2
Registration date: 2013-03-26, 1392/01/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-26, 1392/01/06
Registrant information
Name
Mohammad Jalili
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
00982166418595, 00982166418985
Email address
mjalili@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2012-08-19, 1391/05/29
Expected recruitment end date
2012-12-19, 1391/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy and adverse effects of oxycodone and morphine sulfate in isolated limb trauma patients, admitted to emergency department of Imam Khomeini hospital, between 2011 and 2012 period
Public title
Comparing the efficacy of morphine sulfate and oxycodone in pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: acute lower limb trauma Exclusion criteria: Patients younger than 14 or older than 90 years old, recent use of opioid, advanced liver/respiratory/renal diseases, head trauma, altered mental state, allergy to opioid, pregnancy
Age
From 14 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ETHICS COMMITTEE OF TEHRAN UNIVERSITY OF MEDICAL SICIENCE
Street address
KESHAVARZ BLVD, CENTRAL BULDING OF TEHRAN UNIVERSITY OF MEDICAL SICIENCE
City
TEHRAN
Postal code
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
91-01-30-15974-54352

Health conditions studied

1

Description of health condition studied
Acute lower limb injury
ICD-10 code
s70, s72,
ICD-10 code description
Superficial injury of hip and thigh, Fracture of femur, Dislocation, sprain and strain of joint and ligaments of hip, Injury of muscle and tendon at hip and thigh level, Crushing injury of hip and thigh, Traumatic amputation of hip and thigh, Superficial

Primary outcomes

1

Description
Pain severity
Timepoint
0, 30 and 60 minutes after administration of analgesic
Method of measurement
asking patients, using NRS score

Secondary outcomes

1

Description
Side effects
Timepoint
0, 30 and 60 minute after administration of analgesic
Method of measurement
asking patient, using questionnaire

2

Description
Blood pressure
Timepoint
Zero, 30, and 60 minutes after administration of analgesic
Method of measurement
Checking blood pressure, using appropriate cuff

3

Description
Nausea and vomiting
Timepoint
Zero, 30 and 60 minutes after administration of analgesic
Method of measurement
Asking patient, using questionnaire

4

Description
Drowsiness
Timepoint
Zero, 30 and 60 minutes after administration of analgesic
Method of measurement
Asking patient, using questionnaire

Intervention groups

1

Description
Oxycodone hydrochloride; manufactured by SOHA company; 5 milligrams single dose; oral; in intervention group
Category
Treatment - Drugs

2

Description
Placebo (distilled water); manufactured in Daroupakhsh; single dose; intravenous injection; in intervention group
Category
Treatment - Drugs

3

Description
Morphine sulfate; manufactured in Daroupakhsh; 5 milligrams single dose; intravenous injection; in control group
Category
Treatment - Drugs

4

Description
Placebo; manufactured by SOHA company; single dose; oral; in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency Department of Imam Khomeini Hospital
Full name of responsible person
Mrs.Amani
Street address
Keshavarz Blvd, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Yunesian
Street address
TUMS Central Building, Keshavarz Blvd, Ghods St.
City
Tehran, Iran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Jalili
Position
Vice Chancellor for Education
Other areas of specialty/work
Street address
Room 107, 7th Floor, TUMS Central Building, Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6641 8595
Fax
+98 21 6649 5947
Email
mjalili@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Emergency Department of Imam Khomeini hospital
Full name of responsible person
Mohammad Jalili
Position
Specialist in Emergency Medicine
Other areas of specialty/work
Street address
Room 701, 7th Floor, TUMS Central Building, Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6641 8595
Fax
+98 21 6649 5947
Email
mjalili@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Emergency Department of Imam Khomeini Hospital
Full name of responsible person
Parisa Eizadi
Position
M.D
Other areas of specialty/work
Street address
Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
1457866364
Phone
+98 21 6657 5789
Fax
+98 21 6119 2842
Email
p_eizadi@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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