title: The MERITO Study: a multicentre trial of the analgesic effect and tolerability of normal-release oral morphine during 'titration phase' in patients with cancer pain.
abstract: Adequate and rapid pain control is one of the main goals of cancer pain treatment. The objective of this study was to assess the effect and tolerability of oral normal-release morphine during the initial phase of treatment in patients with moderate-to-severe cancer pain. Consecutive patients naïve to strong opioids received normal-release morphine 5 or 10 mg every 4 h during the titration phase (first 5 days), depending on previous analgesic therapy. Pain intensity was assessed using an 11-point Numerical Rating Scale (0-10), and data were recorded in a patient-compiled diary. The primary endpoint was the proportion of time with pain control (a reduction of at least 50% with respect to the baseline pain score) during the titration phase. A total of 159 consecutive patients (102 men; mean age 65 years) with cancer-related pain were enrolled. Pain control was observed for 75% (95% CI 70-80) of the follow-up period in the intent-to-treat population. Overall, 50% and 75% of patients achieved pain control within 8 and 24 h after starting normal-release morphine therapy respectively. The mean pain score was 7.63 points at baseline, and decreased to 2.43 and 1.67 points (both P<0.001) at days 3 and 5 respectively. The most commonly reported adverse events were somnolence (24% of patients), constipation (22%), vomiting (13%), nausea (10%) and confusion (7%). Normal-release morphine results in rapid and satisfactory pain control, and is well tolerated, during the strong-opioid titration phase in patients with moderate-to-severe cancer pain.
authors.affiliation: Rehabilitation and Palliative Care Operative Unit, IRCCS Foundation, National Cancer Institute, Milano, Italy.
authors.forename: F
authors.initials: F
authors.lastname: De Conno
authors.forename: C
authors.initials: C
authors.lastname: Ripamonti
authors.forename: E
authors.initials: E
authors.lastname: Fagnoni
authors.forename: C
authors.initials: C
authors.lastname: Brunelli
authors.forename: M
authors.initials: M
authors.lastname: Luzzani
authors.forename: M
authors.initials: M
authors.lastname: Maltoni
authors.forename: E
authors.initials: E
authors.lastname: Arcuri
authors.forename: O
authors.initials: O
authors.lastname: Bertetto
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage* / Q000009:adverse effects; D009369:Neoplasms / Q000150:complications*; D010146:Pain / Q000517:prevention & control*
chemical_list: D000701:Analgesics, Opioid; D009020:Morphine