CLINICAL EFFICACY AND SAFETY OF A NOVEL CONTROLLED-RELEASE MORPHINE SUPPOSITORY AND SUBCUTANEOUS MORPHINE IN CANCER PAIN - A RANDOMIZED EVALUATION

Purpose: A significant number of cancer patients will require an alter nate route Of morphine administration at some point during their illne ss, This study compared the clinical efficacy and Safety of a novel mo rphine sulfate controlled-release suppository (MS-CRS) and subcutaneou s (SC) morphine in patients With cancer pain. Methods: Thirty patients with cancer pain were randomized in a double-blind crossover study to MS-CRS every 12 hours or SC morphine every 4 hours for 4 days each, u sing a 2.5:1 analgesic equivalence ratio, Pain intensity Was assessed using a visual analog scale (VAS) and the Present Pain intensity Index Of the McGill Pain Questionnaire. Nausea and Sedation were also asses sed with a VAS. Evaluations Were made by the patient at 8 AM, noon, 4 PM, and 8 PM and rescue morphine consumption recorded. Results: Twenty -three patients completed the study (13 men and 10 women; mean age, 64 .0 +/- 2.0 years) and were treated with mean daily MS-CRS and SC morph ine doses of 326 +/- 69 mg and 138 +/- 28 mg, respectively. There was a small but significant difference in overall ordinal pain-intensity s cores in favor of MS-CRS (0.7 +/- 0.1 v0.9 +/- 0.1, P = .0459). There were no significant differences between MS-CRS and SC morphine in over all VAS scores for pain intensity (13 +/- 3 v13 +/- 3 mm), sedation (2 3 +/- 3 v25 +/- 4 mm), and nausea (8 a 2 v9 +/- 2 mm). The mean daily rescue analgesic consumption during MS-CRS and SC morphine did not dif fer significantly (1.2 +/- 0.4 v1.2 +/- 0.4 doses/d), Conclusion: MS-C RS, administered every 12 hours, provides analgesia comparable to SC m orphine and represents a reliable, noninvasive alternative method of p ain control for patients unable to take oral morphine. (C) 1995 by Ame rican Society of Clinical Oncology.