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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT201112208104N3 |
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Date of registration:
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2012-08-31 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of oxycodone and naproxen in pain control of acute soft tissue injuries
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Scientific title:
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Comparison of oxycodone and naproxen in pain control of soft tissue injuries |
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Date of first enrolment:
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2012-01-01 |
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Target sample size:
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150 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/8516 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Mohammad Amin Zare
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Address:
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Emergency Department, Rasoul Akram Hospital, Niyayesh St; Sattarkhan Ave
14456
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 6652 5327 |
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Email:
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mazare74@yahoo.com |
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Affiliation:
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Tehran University of Medical Sciences |
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Name:
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Mohammad Amin Zare
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Address:
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Emergency Department; Rasoul Akram Hospital, Niyayesh St; Satterkhan Ave
14456
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 6652 5327 |
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Email:
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mazare74@yahoo.com |
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Affiliation:
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Tehran University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criterion: patients above 18 years old with soft tissue injuries. Exclusion criteria: contraindications for opioids and NSAIDs and presence of fracture.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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musculoskeletal system and connective tissue
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soft tissue injuries.
musculoskeletal system and connective tissue
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Intervention(s)
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Second group receive 10 mg Oxycodone
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First group will receive 250 mg Naproxen
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Intervention 1: First group will receive 250 mg Naproxen. Intervention 2: Second group receive 10 mg Oxycodone.
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Treatment - Drugs
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Primary Outcome(s)
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Pain control. Timepoint: 0, 30, 60 minutes after treatment. Method of measurement: Numeric Rating Scale.
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Secondary Outcome(s)
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Presence of side effects. Timepoint: 30 and 60 minutes after treatment. Method of measurement: Patient monitoring.
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Need for follow up analgesic. Timepoint: First 24 hours after discharge. Method of measurement: Telephone follow up.
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Source(s) of Monetary Support
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Vice Chancellor of Research; Tehran University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Tehran University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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