Oral transmucosal fentanyl citrate (OTFC); Actiq) is a drug delivery formulation used for management of breakthrough cancer pain. Previous studies with open-label comparisons indicated OTFC was more effective than patients' usual opioid for breakthrough pain. The objective of this study was to compare OTFC and morphine sulfate immediate release (MSIR) for management of breakthrough pain in patients receiving a fixed scheduled opioid regimen. This double-blind, double-dummy, randomized, multiple crossover study was conducted at 19 US university- and community-based hospitals and clinics and comprised 134 adult ambulatory cancer patients. Patients were receiving a fixed scheduled opioid regimen equivalent to 60-1000 mg/day oral morphine or 50-300 microg/h transdermal fentanyl, were using a 'successful' MSIR dose (15-60 mg) as defined by entry criteria, and were experiencing 1-4 episodes of breakthrough pain per day. In open-label fashion, OTFC was titrated such that a single unit (200-1600 microg) provided adequate pain relief with acceptable side effects. Successfully titrated patients entered the double-blind phase of the study and received ten prenumbered sets of randomized capsules and oral transmucosal units. Five sets were the successful OTFC dose paired with placebo capsules, and five sets were placebo OTFC paired with capsules containing the successful MSIR dose. Patients took one set of study medication for each episode of target breakthrough pain. Pain intensity (PI), pain relief (PR) and global performance of medication (GP) scores were recorded. Pain intensity differences (PID) were calculated and 15-min PID was the primary efficacy variable. Adverse events were recorded. Sixty-nine percent of patients (93/134) found a successful dose of OTFC. OTFC yielded outcomes (PI, PID, and PR) at all time points that were significantly better than MSIR. GP also favored OTFC and more patients opted to continue with OTFC than MSIR following the study. Somnolence, nausea, constipation, and dizziness were the most common drug-associated side effects. In conclusion, OTFC was more effective than MSIR in treating breakthrough cancer pain.

The purpose of this study was to describe direct and indirect costs associated with pain in cancer patients and to examine potential predictors of these costs. The study surveyed cancer outpatients about direct costs resulting from pain-related hospitalizations, emergency department visits, physician office visits, and use of analgesic medications and indirect costs related to money spent on pain-related transportation, complementary methods to improve pain management, educational materials, over-the counter medication, domestic support, and childcare. Furthermore, the study examined age, marital status, race, income level, pain severity, pain interference, and presence of breakthrough pain as predictors of direct and indirect costs. Three hundred and seventy-three cancer outpatients were sampled. One hundred and forty-four cancer patients (39%) reported experiencing cancer-related pain and completed the study questionnaires. Seventy-six percent (76%) of the patients had experienced at least one pain-related cost, resulting in an average monthly direct cost of US$ 891/month per patient. Sixty-nine percent (69%) of patients had experienced some type of direct medical cost due to pain, resulting in an average total direct pain-related cost of US$ 825/month per patient. Fifty-seven percent (57%) of patients reported incurring at least one indirect pain-related expense for an average indirect cost of US$ 61/month per patient. Higher pain intensity, greater pain interference, and presence of breakthrough pain predicted higher direct and indirect medical expenses. Younger age and lower income level also predicted higher direct medical expenses.

Many patients present to day surgery clinics for vaginal termination of pregnancy, a procedure which is frequently complicated by postoperative abdominal pain. We have assessed the efficacy of prophylactic paracetamol 1000 mg given orally shortly before surgery in 834 such patients in a randomised, placebo-controlled, double-blind study. Postoperative pain was reported in 35% of patients, with no significant difference between treated and control patients. This negative finding was unexpected and is so far unexplained, given the usual efficacy of oral paracetamol in relieving this type of pain after it has occurred.

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Patient acceptance is a particularly relevant method of assessing currently employed epidural and intravenous techniques of opioid analgesia after elective caesarean section. We have prospectively studied 71 such patients, randomised postoperatively to receive epidural morphine, intravenous morphine or intravenous pethidine. When compared with either intravenous opioid, epidural morphine provided twofold better average or excellent analgesia with 30% less drowsiness but with about 50% more pruritus. In spite of this troublesome complication, more patients (83% vs 74%) preferred epidural to intravenous opioid analgesia.