NSAIDS Versus Opioids in Acute SER II Ankle Fractures

NCT ID: NCT02373254

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-10-31

Brief 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.

Detailed Description

Pain management in acute fractures is challenging and influenced by several factors contributing to pain perception. These factors include but are not limited to tissue damage by the local impact, mechanical stress at the fracture ends, and central perception of the noxious stimulus. Tissue damage and mechanical stress leads to inflammation and further to local swelling. Swelling itself is significant contributor in pain development.

Ideal pain management would attack pain development at most sites possible. The current clinical practice in the US applies a derivate of an opioid analgesic combined with acetaminophen, thereby influencing pain development at central perception by the opioid analgesic and acetaminophen and a peripheral analgesic effect of acetaminophen. The exact mechanism of the peripheral effect is not known.

This clinical practice disregards the positive effect of medications influencing the peripheral inflammatory response, namely nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs affect pain development by blocking the synthesis of arachidonic acid metabolites, inhibiting peripheral inflammatory response and central pain perception. The major reason for not applying NSAIDs in the treatment of acute fracture pain is an experimental animal study showing decreased bone healing in relation to NSAID usage.

However, clinical data thus far is inconclusive, whether bone healing is affected in humans and whether NSAIDs should be avoided in the setting of bone fractures.

This proposed study will give an answer whether the usage of NSAIDs in acute fractures has a negative effect on bone healing.

Conditions

Ankle Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ibuprofen 400 mg

Ibuprofen 400 mg po q 8 hours as needed (PRN) for pain. Subjects will receive Norco, 5/525 mg po q 6 hours PRN if pain relief with Ibuprofen is not sufficient.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Ibuprofen 400 mg and 800 mg

Ibuprofen 800 mg

Ibuprofen 800 mg po q 8 hours PRN pain. Subjects will receive Norco, 5/525 mg po q 6 hours PRN if pain relief with Ibuprofen is not sufficient.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Ibuprofen 400 mg and 800 mg

Norco

Norco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted.

Group Type: ACTIVE_COMPARATOR

Acetaminophen/hydrocodone

Intervention Type: DRUG

Norco 5/325 mg and 10/325 mg

Interventions

Ibuprofen

Ibuprofen 400 mg and 800 mg

Intervention Type: DRUG

Acetaminophen/hydrocodone

Norco 5/325 mg and 10/325 mg

Intervention Type: DRUG

Other Intervention Names

Motrin; Norco

Eligibility Criteria

Inclusion Criteria

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

• 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Steffner, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis

Sacramento, California, United States

Countries

United States

Other Identifiers

656916

Identifier Type: -

Identifier Source: org_study_id