Efficacy and Safety of Ibuprofen and Caffeine in Dental Pain
Summary
The primary objective of this study is to compare the efficacy of a combination product containing ibuprofen 400 mg and caffeine 100 mg versus either ingredient alone as well as placebo for the treatment of post-surgical dental pain over an eight-hour period followed by a single dose of study medication (study stage 1). A secondary objective is to evaluate efficacy of multiple doses of the combination in comparison to ibuprofen alone over a 5-day post-surgical period (study stage 2).
Timeline
- Start
- 2013-08
- Primary completion
- 2014-03
- Completion
- 2014-03
Outcome
Met primary endpoint
registry analysis (superiority or other test); Ibuprofen vs Ibuprofen/Caffeine; p <0.0001; Mean Difference (Final Values) 12.126 (95% CI 6.493 to 17.759); ANCOVA NCT01929031 ↗
paper Analysis of SPRID0-8 h demonstrated superior analgesic effects for a single dose of ibuprofen/caffeine versus ibuprofen, caffeine and placebo over 8 h PMID 28805281 ↗
Publications
- Forderreuther S, Lampert A, Hitier S, Lange R, Weiser T. The Impact of Baseline Pain Intensity on the Analgesic Efficacy of Ibuprofen/Caffeine in Patients with Acute Postoperative Dental Pain: Post Hoc Subgroup Analysis of a Randomised Controlled Trial. Adv Ther. 2020 Jun;37(6):2976-2987. doi: 10.1007/s12325-020-01297-y. Epub 2020 Apr 24.
- Weiser T, Richter E, Hegewisch A, Muse DD, Lange R. Efficacy and safety of a fixed-dose combination of ibuprofen and caffeine in the management of moderate to severe dental pain after third molar extraction. Eur J Pain. 2018 Jan;22(1):28-38. doi: 10.1002/ejp.1068. Epub 2017 Aug 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 100 mg | — |
| Subject | Ibuprofen | Small molecule | 400 mg | — |