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Acetaminophen/Ibuprofen vs Acetaminophen/Hydrocodone in Hand Surgery
NCT02029235Phase 4
Key facts
- Status
- Terminated
- Start
- Feb 2015
- Primary completion
- Nov 2017
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- ibuprofenhydrocodone
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial in postoperative pain comparing Acetaminophen/Ibuprofen Group with Acetaminophen/Hydrocodone Group (2 arms). Primary endpoint: Efficacy Comparison of Pain Intensity Level at 1 week. Started Feb 2015; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Acetaminophen/Ibuprofen Group
Acetaminophen 500 mg and Ibuprofen 400 mg every 4 hours as needed.
Acetaminophen/Hydrocodone Group
Acetaminophen 325 mg and Hydrocodone 5 mg every 4 hours as needed.
03
Who it enrols
Adult patients undergoing elective soft tissue hand surgery (e.g., carpal tunnel release) without pre-existing pain conditions, renal/liver disease, or pregnancy.
04
Endpoints
Primary
Efficacy Comparison of Pain Intensity Level
Secondary
Efficacy Comparison of Pain Relief
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