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Acetaminophen (Paracetamol) Improves Pain and Well-Being in People With Advanced Cancer Already Receiving a Strong Opioid Regimen: A Randomized, Double-Blind, Placebo-Controlled Cross-Over Trial

From the Department of Medicine and School of Public Health, and NHMRC Clinical Trials Centre, University of Sydney, Camperdown; Sydney Cancer Centre, Concord Repatriation General Hospital, Concord, Australia; and Princess Margaret Hospital, Toronto, Canada

Address reprint requests to Martin Stockler, MBBS, Sydney Cancer Centre, Royal Prince Alfred Hospital–GH6, Missenden Rd, Camperdown, NSW 2050, Australia; e-mail: stockler{at}med.usyd.edu.au

PURPOSE: To determine whether adding regular acetaminophen (paracetamol) could improve pain and well-being in people with advanced cancer and pain despite strong opioids.

PATIENTS AND METHODS: Participants took acetaminophen for 48 hours and placebo for 48 hours. The order (acetaminophen or placebo first) was randomly allocated. Pain was the primary outcome. Preferences, number of opioid breakthrough doses, overall well-being, nausea and vomiting, drowsiness, constipation, and cold sweats were secondary outcomes. Patients rated themselves daily with visual analog scales (VAS) and a verbal numeric scale (VNS) for pain, all scaled from 0 to 10.

RESULTS: Thirty patients completed the trial. The oral opioid was morphine in 23 patients and hydromorphone in seven patients. The median daily opioid dose in oral morphine equivalents was 200 mg (range, 20 to 2,100 mg). Nonsteroidal anti-inflammatory drugs, corticosteroids, or both were used by 16 patients. Pain and overall well-being were better for patients receiving acetaminophen than for those receiving placebo. The mean difference was 0.4 (95% CI, 0.1 to 0.8; P = .03) in VNS for pain, 0.6 (95% CI, –0.1 to 1.3; P = .09) in VAS for pain, and 0.7 (95% CI, 0.0 to 1.4; P = .05) in VAS for overall well-being. More patients preferred the period they took acetaminophen (n = 14) than the period they took placebo (n = 8), but many had no preference (n = 8). There were no differences in the other outcomes.

CONCLUSION: Acetaminophen improved pain and well-being without major side effects in patients with cancer and persistent pain despite a strong opioid regimen. Its addition is worth considering in all such patients.

Supported by a grant from the Cancer Council, New South Wales, Australia, and Janssen Cilag.

Presented in abstract form at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003; the Medical Oncology Group of Australia Annual Scientific Meeting, Canberra, Australia, August 13-15, 2003; and the Clinical Oncology Society of Australia Annual Scientific Meeting, Perth, Australia, November 26-28, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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