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LONG-ACTING CODEINE VS ACETAMINOPHEN/CODEINE IN CHOLECYSTECTOMY PAIN.

Department of Anesthesia, Toronto Western Hospital, University Health Network of University of Toronto, Toronto, Ontario and
^* Purdue Pharma, Pickering, Ontario.

INTRODUCTION

Following ambulatory surgery, long-acting analgesics may be more beneficial vs. short-acting analgesics. This study compared controlled-release codeine (Codeine Contin⁷, CC, Purdue Pharma) and acetaminophen + codeine (A/C; 300 mg/30 mg) for pain control in the 48-hour period following laparoscopic cholecystectomy.

METHODS

This study was approved by the hospital research ethics board. Eligible patients were randomized to CC or A/C in a double-blind, double-dummy, parallel group study. Doses of CC and A/C were: Day 1: 150mg q12h and 8 tabs/d; Day 2: 100mg q12h and 4 tabs/d; respectively. Unrelieved pain in hospital was treated with fentanyl IV bolus. Pain (100 mm VAS) was assessed before the first dose of medication; at 0.5, 1, 2, 3, and 4 hours post-dose; at discharge; and 3 times/day for 48 hours. Reported and observed adverse events were recorded. Patient satisfaction, future use and intention to recommend were assessed at 48 hrs.

RESULTS

84 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 (53.8±10.3 vs. 55.8±13.1, p=0.49). There was no significant difference in the time to onset of analgesia (0.5_0.0 vs. 0.5_0.1 hr, p=0.17). At 0.5 hr, the mean VAS pain was significantly reduced from baseline (p=0.0001) in both groups (37.9±10.8 vs. 39.4±20.4, p=0.74). The VAS SPID scores (4 hr) were 93.0±57.5 and 94.0±60.8 (p=0.87) and VAS pain scores at discharge were 22.3±13.6 and 24.5±15.6 (p=0.61). There was no significant difference in the incidence of adverse events between treatments. For CC and A/C, the number of patients reporting adverse events were: nausea: 12, 6; dizziness: 9, 5; constipation: 4, 4; and vomiting: 6,1. Patients reported similar levels of intention for future use and recommendation of the two treatments. At least moderate satisfaction was reported with CC by 88% of patients, compared to 72% of patients receiving A/C (p=0.17).

DISCUSSION

Controlled-release codeine provides an equivalent onset of analgesia, reduction in post-operative pain, and level of patient satisfaction, to acetaminophen + codeine, over 48 hours following laparoscopic cholecystectomy, with the advantage of less frequent dosing.

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