title: Controlled-release oxycodone versus naproxen at home after ambulatory surgery: a randomized controlled trial.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Department of Anesthesiology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands ; Current affiliation: Department of Anesthesiology and Pain Treatment, Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium.
authors.forename: Björn
authors.initials: B
authors.lastname: Stessel
authors.affiliation: Department of Anesthesiology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.
authors.forename: Maurice
authors.initials: M
authors.lastname: Theunissen
authors.affiliation: Department of Anesthesiology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.
authors.forename: Audrey A
authors.initials: AA
authors.lastname: Fiddelers
authors.affiliation: Department of Anesthesiology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.
authors.forename: Elbert A
authors.initials: EA
authors.lastname: Joosten
authors.affiliation: Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.
authors.forename: Alfons G
authors.initials: AG
authors.lastname: Kessels
authors.affiliation: Department of Anesthesiology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands.
authors.forename: Hans-Fritz
authors.initials: HF
authors.lastname: Gramke
authors.affiliation: Department of Anesthesiology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands ; Current affiliation: Department of Anesthesia/ICU, Pain, and Palliative Care, Hamad Medical Corporation, PO Box 3050, Doha, Qatar.
authors.forename: Marco A
authors.initials: MA
authors.lastname: Marcus
keywords: Ambulatory surgery; Analgesics; CR oxycodone; Nonnarcotic; Opioid; Pain; Postoperative; Randomized controlled trial