NSAIDS Versus Opioids in Acute SER II Ankle Fractures
Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jan 2015
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJuly 14, 2017
July 1, 2017
9 months
February 9, 2015
July 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
fracture healing as measured by radiographic evaluation
fracture healing at 12 weeks followup
12 weeks
Secondary Outcomes (2)
pain level improvement as measured by VAS score
1 week, 2 weeks, 6 weeks, 9 weeks and 12 weeks
functional improvement as measured by AAOS score
1 weeks, 2 weeks 6 weeks, 9 weeks and 12 weeks
Study Arms (3)
Ibuprofen 400 mg
ACTIVE COMPARATORIbuprofen 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.
Ibuprofen 800 mg
ACTIVE COMPARATORIbuprofen 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.
Norco
ACTIVE COMPARATORNorco (acetaminophen/hydrocodone) 10/325 mg po q 6 hours PRN pain. If pain is not relieved, physician should be contacted.
Interventions
Eligibility Criteria
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
- Adults unable to consent
- Pregnant women
- Prisoners
- Workers Comp patient
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California Davis
Sacramento, California, 95817, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Steffner, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2015
First Posted
February 26, 2015
Study Start
January 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
July 14, 2017
Record last verified: 2017-07