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Controlled-release codeine is equivalent to acetaminophen plus codeine for post-cholecystectomy analgesia

[La codéine à libération contrôlée est équivalente à de l’acétaminophène plus de la codéine pour l’analgésie postcholécystectomie]

Frances Chung, MD^*, Doris Tong, MD^*, Paula C. Miceli, MSc, Joseph Reiz, BSc, Zoltan Harsanyi, MBA, Andrew C. Darke, PhD and Lance W. Payne, PHARMD

^* From the Department of Anesthesia, Toronto Western Hospital, University of Toronto, Toronto; and
Purdue Pharma, Pickering, Ontario, Canada.

Address correspondence to: Dr. Frances Chung, Department of Anesthesia, Toronto Western Hospital, 399 Bathurst Street, Toronto, Ontario M5T 2S8, Canada. Phone: 416-603-5118; Fax: 416-603-6494; E-mail: frances.chung{at}uhn.on.ca

Purpose: Following ambulatory surgery, long-acting analgesics may provide advantages over short-acting analgesics. This study compared controlled-release codeine (CC) and acetaminophen plus codeine (A/C; 300 mg/30 mg) for pain control in the 48-hr period following laparoscopic cholecystectomy.

Methods: Eligible patients were randomized to CC or A/C in a double-blind, double-dummy parallel group study. Unrelieved pain in hospital was treated with fentanyl iv bolus. Pain [100 mm visual analogue scale (VAS)] was assessed before the first dose of medication; at 0.5, one, two, three, and four hours post-dose; at discharge; and three times a day for 48 hr. Adverse events were recorded and measures of patient satisfaction were assessed at the end of the study.

Results: Eighty-four patients were enrolled in the study; 42 patients in each group. There were no statistically significant differences between CC and A/C treatment. Mean VAS baseline pain was similar in both groups (P = 0.49) and there was no significant difference in the time to onset of analgesia (P = 0.17). At 0.5 hr, the mean VAS pain score was significantly reduced from baseline in both groups (P = 0.0001). The VAS pain scores at discharge were reduced 59% and 56% from baseline, respectively (P = 0.61). There was no difference between treatments in the incidence of adverse events and patients reported similar levels of satisfaction.

Conclusions: Controlled-release codeine provides an equivalent onset of analgesia, reduction in postoperative pain, and level of patient satisfaction, to acetaminophen plus codeine, over 48 hr following cholecystectomy, with the advantage of less frequent dosing.