Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial

Björn Stessel, Maurice Theunissen, Audrey A Fiddelers, Elbert A Joosten, Alfons G Kessels, Hans-Fritz Gramke, Marco A Marcus, Björn Stessel, Maurice Theunissen, Audrey A Fiddelers, Elbert A Joosten, Alfons G Kessels, Hans-Fritz Gramke, Marco A Marcus

Abstract

Background: Strong opioids in the home setting after ambulatory surgery have rarely been studied for fear of hazardous adverse effects such as respiratory depression.

Objectives: We compared the efficacy of paracetamol/controlled-release (CR) oxycodone and paracetamol/naproxen for treatment of acute postoperative pain at home after ambulatory surgery. Secondary outcomes were adverse effects of study medication, treatment satisfaction, and postoperative analgesic compliance.

Methods: Patients undergoing ambulatory knee arthroscopy or inguinal hernia repair surgery (n = 105) were randomized into 3 groups: Group1 paracetamol/naproxen (n = 35), Group 2 paracetamol/CR oxycodone for 24 hours (n = 35), and Group 3 paracetamol/CR oxycodone for 48 hours (n = 35). Pain intensity at movement and at rest using a visual analog scale as well as satisfaction with postoperative analgesia and side effects were recorded for up to 48 hours postoperatively. Compliance with study medication was also assessed.

Results: For pain at movement and at rest, no significant differences were found between the paracetamol/naproxen group and either the paracetamol/CR oxycodone for 24 hours group (β = 2.6 [4.9]; P = 0.597) or the paracetamol/CR oxycodone for 48 hours (β = -1.7 [5.1]; P = 0.736). No major adverse effects of study medication were registered and satisfaction with postoperative pain treatment was high in all groups. Compliance was comparable across the groups. Despite clear instructions, 8 patients with the lowest pain scores did not use any of the prescribed pain medication.

Conclusions: Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.

Keywords: Ambulatory surgery; Analgesics; CR oxycodone; Nonnarcotic; Opioid; Pain; Postoperative; Randomized controlled trial.

Figures

Figure 1
Figure 1
Study flow chart. Analysis according to intention-to-treat principle. PCM/NAPR = paracetamol/naproxen; PCM/Oxy24h = paracetamol/oxycodone for 24 hours; PCM/Oxy48h = paracetamol/oxycodone for 48 hours.
Figure 2
Figure 2
Pain at movement on Postoperative Days 1 and 2. Median (interquartile range), based on visual analog scale rating (0–100). PCM/NAPR = paracetamol/naproxen; PCM/OXY1 = paracetamol/oxycodone for 24 hours; PCM/OXY2 = paracetamol/oxycodone for 48 hours.

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