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Opioids vs Non-opioids in ACL Reconstruction
NCT04285853Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2020
- Primary completion
- Sep 2022
- Countries
- 1
- Sponsor
- Emory University
- Modality
- Small Molecules
- Drugs
- oxycodone
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial in postoperative pain comparing Oxycodone Arm with Placebo Arm (2 arms). Primary endpoint: Numeric Rating Scale for Pain. Started Sep 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Oxycodone Arm
15 tablets of 5mg Oxycodone + Placebo rescue + SOC
Placebo Arm
15 tablets of Placebo + Oxycodone rescue + SOC
03
Who it enrols
Patients aged 14-40 scheduled for primary ACL reconstruction using quadriceps tendon autograft, excluding those with chronic pain medication use, weight <50 kg, or liver/renal dysfunction.
04
Endpoints
Primary
Numeric Rating Scale for Pain
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