Protocol summary

Summary
Soft tissue injury is a common problem in emergency departments.Pain control is the cornerstone in patient satisfaction and compliance of patients with soft tissue injuries. The effective and safe drugs in pain control have been always interested and this study tries to compare one of the most common drugs used in soft tissue pain control (naproxen) with an oral opiod(oxycodone). This study is a double blind randomized trial which is conducted in an academic emergency department. All patients over 18 years old suspicious to soft tissue injury would be included and randomized in 2 group, Naproxen 500 mg or Oxycodone 10 mg will be given to them orally and their pain score would be followed before, 30 minutes and 60 minutes after receiving the medication.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112208104N3
Registration date: 2012-08-31, 1391/06/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-31, 1391/06/10
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2012-05-01, 1391/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oxycodone and naproxen in pain control of soft tissue injuries
Public title
Comparison of oxycodone and naproxen in pain control of acute soft tissue injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients above 18 years old with soft tissue injuries. Exclusion criteria: contraindications for opioids and NSAIDs and presence of fracture.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 150
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods street- Keshavarz blvd-tehran
City
Tehran
Postal code
-
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
130/206/د/91

Health conditions studied

1

Description of health condition studied
soft tissue injuries
ICD-10 code
XIII
ICD-10 code description
musculoskeletal system and connective tissue

Primary outcomes

1

Description
Pain control
Timepoint
0, 30, 60 minutes after treatment
Method of measurement
Numeric Rating Scale

Secondary outcomes

1

Description
Presence of side effects
Timepoint
30 and 60 minutes after treatment
Method of measurement
Patient monitoring

2

Description
Need for follow up analgesic
Timepoint
First 24 hours after discharge
Method of measurement
Telephone follow up

Intervention groups

1

Description
First group will receive 250 mg Naproxen
Category
Treatment - Drugs

2

Description
Second group receive 10 mg Oxycodone
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
RASOUL AKRAM HOSPITAL
Full name of responsible person
MOHAMMAD AMIN ZARE
Street address
Emergency Department, Rasoul Akram Hospital, Niyayesh St; Sattarkhan Ave
City
TEHRAN

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor of Research; Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhoundzadeh
Street address
Qods Ave, Keshawarz Blvd
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of 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 Amin Zare
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department; Rasoul Akram Hospital, Niyayesh St; Satterkhan Ave
City
Tehran
Postal code
14456
Phone
+98 21 6652 5327
Fax
+98 21 6652 5327
Email
mazare74@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amin Zare
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Rasoul Akram Hospital, Niyayesh St; Sattarkhan Ave
City
Tehran
Postal code
14456
Phone
+98 21 6652 5327
Fax
+98 21 6652 5327
Email
mazare74@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amin Zare
Position
Assistant Professor
Other areas of specialty/work
Street address
Emergency Department, Rasoul Akram Hospital, Niyayesh St; Sattarkhan Ave
City
Tehran
Postal code
14456
Phone
+98 21 6652 5327
Fax
+98 21 6652 5327
Email
mazare74@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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