NSAIDS Versus Opioids in Acute SER II Ankle Fractures

Completed · Early Phase 1

Conditions studied: Ankle Fracture

In brief

This study is being conducted to evaluate whether NSAIDS are more or less effective in bone healing than opioids in acute fracture pain. Participants will be randomized to one of three groups for first line treatment of pain related to the fracture.

Key facts

Study ID

NCT02373254

Run by

University of California, Davis

People needed

1

Starts

2015-01-01

Expected to finish

2015-10-01

Last updated by the study team

2017-07-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 to < 60
• Isolated ankle fracture type SER II
• Ability to speak and understand English
• BMI< 35

You may not qualify if…

• ASA>3
• Previous or acute gastric bleeding
• Renal insufficiency (Creatinine: >1.27mg/dl)
• Liver insufficiency (Child-Pugh-Wert: 10-15)
• Malignant tumor
• Rheumatoid arthritis
• Heart failure (NYHA III-IV)
• High frequency absolute arrhythmia
• Patients with known psychiatric illness
• Coagulopathy
• Asthma
• Function limiting disease of the lower extremity, besides what is mentioned in the inclusion criteria
• Adults unable to consent
• Pregnant women
• Prisoners
• Workers Comp patient
• Early fracture displacement (within first 2 weeks) indicating need for surgery
• Polytrauma
• Concurrent participation in another clinical trial

Where it is running

• University of California Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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