NSAIDS Versus Opioids in Acute SER II Ankle Fractures

University of California (UC) Davis

Status and phase

Completed

Early Phase 1

Conditions

Ankle Fracture

Treatments

Drug: Acetaminophen/hydrocodone

Drug: Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT02373254

656916

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1 participants in 3 patient groups

Ibuprofen 400 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen

Ibuprofen 800 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen

Norco

Active Comparator group

Description:

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