*Based on a clinical study vs hydrocodone plus acetaminophen (HYD+APAP) during the first 4 hours after initial dosing.
Use as directed for minor aches and pains.
Aleve®, a non-opioid OTC NSAID, was compared with HYD+APAP for dental pain relief1 in a recent, single-center, randomized, double-blind, parallel, placebo-controlled single-dose study.1
- Patients experiencing moderate or severe pain (N=221) after surgical removal of impacted third molars were randomized to receive either a single dose of Aleve® (440 mg [n=90]), HYD+APAP (10 mg + 650 mg [n=87]), or placebo (n=44)
- The primary objective was to compare Sum of Pain Intensity Difference from 0 to 12 hours (SPID0-12) after a single oral dose
- Secondary objectives were to compare the total pain relief (TOTPAR) over 6 and 12 hours, SPID0-6, time to onset of pain relief, time to first use of rescue medication, and duration of pain intensity at least half gone over 6 and 12 hours
- SPID0-4 was also assessed
In the study, Aleve® was as effective† as HYD+APAP at hours 0 to 4 at reducing pain intensity1,‡
STUDY RESULTS
The primary endpoint was met
SPID0-12 was statistically significant for Aleve® vs HYD+APAP.
Key secondary endpoints also showed statistical significance compared with HYD+APAP:
- TOTPAR (0 to 6 and 0 to 12 hours; P<0.05)
- Median time to rescue medication (P<0.001)
- Duration of pain at least half gone over 12 hours (P<0.001)
Both active treatments were significantly more effective than placebo
HYD+APAP was not statistically superior to Aleve® for any endpoint.
†In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg), hydrocodone plus acetaminophen, HYD+APAP (10 mg + 650 mg), or placebo.1
‡Based on SPID0-4.
More treatment-related adverse events were reported with HYD+APAP (n=18) than Aleve® (n=1), including nausea, vomiting, and dizziness.1
The growing body of evidence offers a compelling argument for first-line use of an NSAID like Aleve®, and professional organization guidelines suggest ways of putting NSAIDs into practice.1-8
When prescribing any product, HCPs should always consider its efficacy and safety. Before any procedure requiring pain management, HCPs should talk with patients about the benefits and risks.
References: 1. Cooper SA, Desjardins PJ, Bertoch T, et al. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial. Postgrad Med. 2021. doi:10.1080/00325481.2021.2008180 2. Data on file. Bayer Consumer Health. 3. Kiersch TA, Halladay SC, Hormel PC. A single-dose, double-blind comparison of naproxen sodium, acetaminophen, and placebo in postoperative dental pain. Clin Ther. 1994;16(3):394-404. 4. American Dental Association announces new policy to combat opioid epidemic. News release. American Dental Association. March 26, 2018. Accessed May 25, 2023. https://www.prnewswire.com/news-releases/american-dental-association-announces-new-policy-to-combat-opioid-epidemic-300618928.html 5. American Dental Association. Statement on the use of opioids in the treatment of dental pain. October 2016. Accessed May 25, 2023. https://www.ada.org/about/governance/current-policies#substanceusedisorders 6. American Association of Oral and Maxillofacial Surgeons. Opioid prescribing: acute and postoperative pain management; 2020. White Paper. Accessed May 25, 2023. https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/opioid_prescribing.pdf 7. American Academy of Orthopaedic Surgeons. Management of osteoarthritis of the knee (non-arthroplasty). Evidence-based clinical practice guideline. May 1, 2022. Accessed June 15, 2023. https://journals.lww.com/jaaos/Fulltext/2022/05010/AAOS_Clinical_Practice_Guideline_Summary_.10.aspx 8. Kolasinksi SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Rheumatol. 202;72(2): 220-233. doi:10.1002/art.41142