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Purpose:
This study was conducted to compare the efficacy and safety of naproxen 500 mg twice daily (BID) versus naproxen 500 mg as needed (PRN) for treatment of ankle sprain.
Asian Journal of Sports Medicine
Sports Medicine Research Center, TUMS
Naproxen Twice Daily Versus as Needed (PRN) Dosing: Efficacy and Tolerability for Treatment of Acute Ankle Sprain, a Randomized Clinical Trial
Author(s):
Majid Hajimaghsoudi1, 
Mohammad Jalili
2,*, Mehdi Mokhtari3, Amir Nejati2, Javad Mesbahi2, Koosha Paydary41Emergency Medicine Department, Shahid Sadoughi Hospital, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
2Emergency Medicine Department, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran
3Department of Epidemiology, Urmia University of Medical Sciences, Urmia, Iran
4Students Scientific Research Center (SSRC), Tehran University of Medical Sciences, Tehran, Iran
Published online:Aug 01, 2013
Article type:Research Article
Received:Mar 30, 2013
Accepted:Jul 15, 2013
How to Cite:Hajimaghsoudi M, Jalili M, Mokhtari M, Nejati A, Mesbahi J, et al. Naproxen Twice Daily Versus as Needed (PRN) Dosing: Efficacy and Tolerability for Treatment of Acute Ankle Sprain, a Randomized Clinical Trial. Asian J Sports Med. 2013;4(4):34243. doi: https://doi.org/10.5812/asjsm.11411
Abstract
Methods:
In this seven-day, randomized, parallel group trial, 135 patients with ankle sprain occurring less than 48 hours prior to the first dose of study medication were randomized to receive naproxen 500 mg BID (67 patients) and naproxen 500 mg as needed (PRN) (68 patients). The ankle pain was assessed at rest and on full weight bearing using Numeric Rating Scale (NRS) from 0 (no pain) to 10 (the worst imaginable pain). Ankle swelling was assessed as a 4-point scale ranging from 0 (no swelling) to 3 (severe swelling) rated by the investigator. The primary efficacy end point was the patient's assessment of ankle pain via NRS and the degree of swelling on day seven.
Results:
Results showed a significant decrease in pain on weight bearing, pain at rest and the extent of swelling (
Conclusion:
Results showed that naproxen as needed may reduce the pain and edema of the sprained ankle with no significant difference compared to the BID regimen, while it possesses better safety profile and lower total drug use.
Copyright
© 2013, Author(s). This open-access article is available under the Creative Commons Attribution 4.0 (CC BY 4.0) International License (https://creativecommons.org/licenses/by/4.0/), which allows for unrestricted use, distribution, and reproduction in any medium, provided that the original work is properly cited.
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