Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

• Published in: Current therapeutic research Vol. 76; no. C; pp. 120 - 125
• Main Authors: Stessel, Björn, MD, Theunissen, Maurice, MSc, Fiddelers, Audrey A., PhD, Joosten, Elbert A., PhD, Kessels, Alfons G., MD, MSc, Gramke, Hans-Fritz, MD, PhD, Marcus, Marco A., MD, PhD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.12.2014; Elsevier
• Subjects: Ambulatory surgery; Analgesics; CR oxycodone; Internal Medicine; Medical Education; Nonnarcotic; Opioid; Pain; Postoperative; Randomized controlled trial; Postoperative; Ambulatory surgery; Pain; Analgesics; Opioid; Nonnarcotic; Randomized controlled trial; CR oxycodone
• ISSN: 0011-393X; 1879-0313
• DOI: 10.1016/j.curtheres.2014.10.001

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.