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Caldolor vs Ofirmev for Third Molar Surgery Pain
NCT02133326Phase 2
Key facts
- Status
- Unknown
- Start
- Mar 2014
- Primary completion
- Jan 2017
- Countries
- 1
- Sponsor
- Tufts University
- Modality
- Small Molecules
- Drugs
- ibuprofen
- Conditions
- postoperative pain
01
Overview
Phase 2, randomised, double-blind trial of ibuprofen in postoperative pain (2 arms), sponsored by Tufts University. Primary endpoint: Clinical report of pain (VAS). Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Caldolor
800 mg IV Ibuprofen administered 30 mins pre-op.
Ofirmev
1000 mg IV Acetaminophen administered 30 mins pre-op.
03
Who it enrols
Adult patients (18+) undergoing extraction of at least two impacted third molars (full or partial bony) under ambulatory general anesthesia. Must be ASA I/II. Excludes pregnant patients, those with allergies to ibuprofen/acetaminophen, history of substance abuse, current use of pain/anti-inflammatory meds, chronic pain conditions, or active infection.
04
Endpoints
Primary
Clinical report of pain (VAS)
Secondary
Pain medication consumption
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