Naproxen Sodium: Comparative Efficacy and Tolerability of Two Dosages for Pain After Joint Surgery

Abstract

In a multicenter, randomized, double-blind, parallel trial, the efficacy and tolerability of two regimens of naproxen sodium were compared in a two-day treatment of moderate to severe pain following open surgery of the hip, shoulder, knee, and ankle joints. Of 147 patients enrolled, the data of 99 were valid for efficacy analysis, 45 in the low-dose regimen (day 1, 1,100 mg; day 2,825 mg) and 54 in the highdose regimen (1,650 mg/day). At 12 interviews each day, patients evaluated intensity of pain using numerical scales and recorded complaints. At the end of the study, overall efficacy was evaluated. Although there were no statistically significant differences between the two regimens for efficacy or tolerability, the highdose regimen achieved greater pain relief in patients who had hip or shoulder surgery, suggesting that this regimen had greater cumulative efficacy for these patients.

Low-Dose NSAIDs Efficacy in Orthopedic Applications

“…58 Low-dose naproxen sodium is effective and safe in patients undergoing joint surgery; however, the high dosage reduced pain to a greater extent. 24 The GI tolerability of naproxen plus a gastroprotection does not differ significantly from that of celecoxib in patients taking aspirin at low doses. 24,31 In a randomized controlled trial (RCT), 14 an intraarticular knee injection of low-dose ketorolac (5 mg) after arthroscopy did not provide any benefits.…”

“…Low-dose naproxen sodium is effective and safe in patients undergoing joint surgery; however, the high dosage reduced pain to a greater extent 24…”

“…The GI tolerability of naproxen plus a gastroprotection does not differ significantly from that of celecoxib in patients taking aspirin at low doses 24,31…”

“…Therefore, although it does not reduce the incidence of VTE after THA compared to usual dosage aspirin, the low dosage may be useful to reduce the side effects related to such drugs, for example, the dose-dependent risk of GI bleeding. [22][23][24] An important issue related to the prevention of VTE after TJA was addressed in the study of Krauss et al, 34 in which there was an increased risk of VTE after TJA related to the interaction between low-dose aspirin (81 mg twice daily) and other NSAIDs (ie, celecoxib) in the context of associative pain therapies. While GI safety appears unaffected by low-dose aspirin (81 mg) alone, in case of coadministration with other medications such as rofecoxib or ibuprofen, there is an increased risk of gastric and duodenal ulcers.…”

“…Low-dose aspirin is, however, no less effective than the standard dosage. Therefore, although it does not reduce the incidence of VTE after THA compared to usual dosage aspirin, the low dosage may be useful to reduce the side effects related to such drugs, for example, the dose-dependent risk of GI bleeding 22–24…”