NSAIDS Versus Opioids in Acute SER II Ankle Fractures

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Ibuprofen; Oxycodone

Criteria

Inclusion Criteria:

• Age > 18 to < 60

• Isolated ankle fracture type SER II

• Ability to speak and understand English

• BMI< 35

Exclusion Criteria:

• 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