title: A comparison of oxycodone prolonged-release vs. oxycodone + naloxone prolonged-release after laparoscopic hysterectomy.
abstract: BACKGROUND
  Targiniq®, an oxycodone prolonged-release (PR) formulation combined with the opioid antagonist naloxone PR, aims to prevent opioid-induced constipation without impairing the analgesic efficacy. This has been confirmed during prolonged use in chronic pain or cancer patients. The purpose of our study was to compare clinical effects of oxycodone PR with oxycodone PR + naloxone PR for short-term post-operative pain management.
  
  
  METHODS
  This randomised, double-blind, prospective study included 85 women undergoing laparoscopic hysterectomy. The two groups received either oxycodone PR 10 mg or oxycodone PR 10 mg + naloxone PR 5 mg as pre-medication and twice daily for 3 days. As rescue analgesic, the patients received oxycodone intravenous during the first 24 h post-operatively and oxycodone tablets in the 24-72-h period. Constipation, other side effects, pain and satisfaction were registered during the first 7 post-operative days.
  
  
  RESULTS
  Demographic, pre- and perioperative variables and the use of rescue analgesics were similar in the groups. There were no significant differences in variables related to constipation. In the oxycodone PR + naloxone PR group, 25% had no defecation during the first 72 h post-operatively, compared with 20% in the oxycodone PR group (mean 1.2 ± 1.1 vs. 2.1 ± 2.4 defecations). Other opioid-induced effects and side effects showed no significant differences. Only 7% were dissatisfied with their oral pain treatment.
  
  
  CONCLUSIONS
  Addition of naloxone to oxycodone PR tablets in a pain regimen administered twice daily the first three post-operative days had no significant clinical effects on constipation or other variables during the first week after hysterectomy.
authors.affiliation: Department of Anaesthesiology - Ullevaal, Oslo University Hospital, Oslo, Norway. marlin.comelon@gmail.com
authors.forename: M
authors.initials: M
authors.lastname: Comelon
authors.forename: K
authors.initials: K
authors.lastname: Wisloeff-Aase
authors.forename: J
authors.initials: J
authors.lastname: Raeder
authors.forename: T
authors.initials: T
authors.lastname: Draegni
authors.forename: H
authors.initials: H
authors.lastname: Undersrud
authors.forename: E
authors.initials: E
authors.lastname: Qvigstad
authors.forename: C E
authors.initials: CE
authors.lastname: Bjerkelund
authors.forename: H
authors.initials: H
authors.lastname: Lenz
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D003248:Constipation / Q000517:prevention & control; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007044:Hysterectomy; D010535:Laparoscopy; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage* / Q000009:adverse effects; D009292:Narcotic Antagonists / Q000008:administration & dosage; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects; D010149:Postoperative Pain / Q000188:drug therapy*; D011446:Prospective Studies
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009270:Naloxone; D010098:Oxycodone