drugset / Trial / NCT02689063
Maxigesic IV Phase 3 Bunionectomy Study
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to determine the clinical efficacy and safety of Maxigesic IV, acetaminophen IV, Ibuprofen IV versus placebo IV for the treatment of acute postoperative pain after bunionectomy
Timeline
- Start
- 2016-10-26
- Primary completion
- 2017-06-30
- Completion
- 2017-09-15
Publications
- Ferguson MC, Schumann R, Gallagher S, McNicol ED. Single-dose intravenous ibuprofen for acute postoperative pain in adults. Cochrane Database Syst Rev. 2021 Sep 9;9(9):CD013264. doi: 10.1002/14651858.CD013264.pub2.
- Daniels SE, Playne R, Stanescu I, Zhang J, Gottlieb IJ, Atkinson HC. Efficacy and Safety of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Bunionectomy: a Randomized, Double-blind, Factorial, Placebo-controlled Trial. Clin Ther. 2019 Oct;41(10):1982-1995.e8. doi: 10.1016/j.clinthera.2019.07.008. Epub 2019 Aug 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 1000 mg | Intravenous |
| Comparator | Ibuprofen | Small molecule | 300 mg | Intravenous |
Indications
No indication recorded.