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440 <strong>EAPC</strong> Abstracts<br />

Significantly fewer patients on the pain-adjusted dose received adjunct<br />

analgesics (58.0% vs. 70.5%). More than 50% of patients had time-of-day<br />

fluctuation in pain intensity at start of study (mean 5.6 (midday) – 6.5<br />

(night). At day 7, levels had significantly decreased to mean 2.8 (night,<br />

morning, midday) or mean 2.9 (evening). By the end, more patients on<br />

pain-adjusted dosage showed improved pain relief than those on fixed dose<br />

(73.8% vs. 70.5%). Quality of life improved more than 50% overall. On<br />

final exam, physicians rated fluctuation as “much improved“ or “improved”<br />

for 88.8% of patients on pain-adjusted dosage. 91.7% of physicians rated<br />

HM efficacy and tolerability as “very good“ or “good“. Conclusions: More<br />

than 50% of patients reported time-of-day differences in pain intensity.<br />

Flexible, 2xday HM dosage improved even time-of-day fluctuation in pain<br />

intensity and quality of life; pain levels dropped through pain-adjusted<br />

dosage. * Palladon ® , Mundipharma GmbH.<br />

136 Oral Presentation<br />

Pain 2<br />

Quality of life in patients treated with controlled release dihydrocodeine<br />

and tramadol – results of a prospective, randomized,<br />

cross-over study<br />

Authors: Wojciech Leppert Chair and Department of Palliative<br />

MedicinePoznan University of Medical Sciences POLAND<br />

Mikolaj Majkowicz Department of Quality of Life Research, Gdansk<br />

Medical University Gdansk POLAND<br />

Background: The aim of the study to assess analgesia, side effects and<br />

quality of life (QL) during dihydrocodeine controlled release tablets (DHC<br />

Continus ® 60, 90, 120 mg) and tramadol controlled release tablets<br />

(Tramundin ® 100 mg, Tramal Retard ® 100, 150, 200 mg) administration to<br />

patients with cancer pain Methods: Prospective, 30 opioid – naive patients<br />

with moderate to severe cancer pain intensity of nociceptive (visceral or<br />

somatic) type treated with non-opioid analgesics, randomised, cross–over,<br />

7 days each no wash – out. Visceral pain 14 patients, bone 10 and mixed 6.<br />

Pain intensity: 24 patients moderate (NRS 3 – 5), 6 severe (NRS > 5).<br />

Analgesia by NRS (Brief Pain Inventory – Short Form), side effects verbal<br />

scale, ESAS, QL by EORTC QLQ C 30. Starting initial dose DHC 2x60<br />

mg, titrated 2x90,2x120 up to 2x180 or 3x120, tramadol 2x100 mg, titrated<br />

2x150, 2x200 up to 2x300 or 3 x 200. Changing drugs – equianalgesic<br />

doses (tramadol = DHC): 2x100 = 2x60, 2x150 = 2x90, 2x200 = 2x120,<br />

2x300 = 2x180. Results: Significant pain relief in both groups but analgesia<br />

significantly superior in DHC group and there was less nausea and less<br />

dyspnoea. Constipation and drowsiness significantly more intense in DHC<br />

group. Global QL better in DHC group. In both groups side effects did not<br />

caused cessation of the treatment and respiratory depression not observed.<br />

Conclusions: 1. Dihydrocodeine and tramadol in controlled release tablets<br />

are effective analgesics in the treatment of nociceptive cancer pain of moderate<br />

intensity but DHC provided significantly better analgesia. 2. Quality<br />

of life results showed better analgesia and global QL in DHC group and<br />

more intense nausea, less drowsiness and less constipation in tramadol<br />

group. The tolerance of the treatment was good in both groups with no serious<br />

side effects like respiratory depression or allergy for the drug. 3. The<br />

second step of the WHO analgesic ladder is important for the treatment of<br />

patients with nociceptive cancer pain of moderate intensity.<br />

137 Oral Presentation<br />

Pain 2<br />

A randomised, double-blind, placebo-controlled, parallel-group<br />

study comparing oral racemic ketamine and S ketamine in the<br />

treatment of cancer-related neuropathic pain<br />

Authors: Marie Fallon Palliative Medicine University of Edinburgh<br />

UNITED KINGDOM<br />

Caroline Bray Beatson Oncology Centre Glasgow UNITED KINGDOM<br />

Angela Boyd University of Edinburgh Edinburgh UNITED KINGDOM<br />

Terry Nichols Napp Pharmaceuticals Ltd (now Mundipharma Research<br />

Ltd) Cambridge UNITED KINGDOM<br />

Lesley Colvin University of Edinburgh Edinburgh UNITED KINGDOM<br />

AJ Miller Napp Pharmaceuticals Ltd Cambridge UNITED KINGDOM<br />

O’Brien Cathy Fincham Statistics Fincham UNITED KINGDOM<br />

Barry Laird University of Edinburgh Edinburgh UNITED KINGDOM<br />

Background: Neuropathic cancer pain remains a clinical challenge. The S-<br />

enantiomer of the NMDA receptor antagonist ketamine may provide analgesia<br />

with a greater potency than racemic ketamine with fewer excitatory<br />

side effects. This study evaluated the efficacy and tolerability of oral solutions<br />

of S-ketamine, racemic ketamine, and placebo in moderate to severe,<br />

cancer-related, neuropathic pain. Methods: A multi-centre randomised controlled<br />

trial which recruited patients from hospitals and hospices in the UK.<br />

Inclusion criteria: moderate to severe, cancer related neuropathic pain,<br />

despite treatment with a strong opioid for moderate to severe pain. The<br />

study consisted of a titration period of up to seven days, followed by a two<br />

day assessment period. The primary efficacy variable was pain intensity<br />

which was assessed using the Box-11 pain score. Other efficacy measures<br />

included the Brief Pain Inventory (BPI) and short-form McGill Pain<br />

Questionnaire(MPQ). Results: 65 patients were recruited with 22 (34%)<br />

receiving S-ketamine, 22 (34%) racemic ketamine, and 21 (32%) placebo.<br />

38 patients (84%) completed the study. S-Ketamine, racemic ketamine and<br />

placebo were associated with analgesia and there was no statistically significant<br />

differences between treatment groups in the primary efficacy variable<br />

during the assessment period (ANCOVA morning: P=0.829, midday:<br />

P=0.480, evening: P=0.844). S-ketamine provided the largest reduction in<br />

the MPQ sensory, affective, and total pain intensity scores (total mean pain<br />

intensity scores: 21.9 [SD 8.7] at baseline to 4.9 [SD 6.4] at study endpoint)<br />

but this did not reach statistical significance (sensory pain: P=0.068, affective<br />

pain: P=0.316, and total pain P=0.073). Conclusions: Based on the primary<br />

efficacy variable, the analgesic effects of ketamine and S-ketamine<br />

were not statistically significant from placebo. Beneficial trends were<br />

observed in the MPQ sensory descriptors. A much larger trial would be<br />

required to show statistical significance.<br />

138 Oral Presentation<br />

Pain 2<br />

Can gradual dose titration of ketamine prevent psychotomimetic<br />

effects of advanced cancer patients with neuropathic<br />

pain<br />

Authors: Yoshiaki Okamoto Graduate School of Pharmaceutical Science<br />

Osaka University JAPAN<br />

Yumiko Ono Osaka University Suita Osaka JAPAN<br />

Soitiro Yasuda Osaka University Suita Osaka JAPAN<br />

Keiko Tazumi Osaka University Suita Osaka JAPAN<br />

Satoru Tsuneto Osaka University Suita/Osaka JAPAN<br />

Sho Goya Osaka University Suita Osaka JAPAN<br />

Hitoshi Tanimukai Osaka University Suita Osaka JAPAN<br />

Yoichi Matsuda Osaka University Suita Osaka JAPAN<br />

Hiroshi Eto Osaka University Suita Osaka JAPAN<br />

Yoshie Toya Osaka University Suita Osaka JAPAN<br />

Etsuko Uejima Osaka University Suita Osaka JAPAN<br />

Nobuo Kurokawa Osaka University Suita Osaka JAPAN<br />

Introduction: Ketamine is an N-methyl-D-aspartate receptor antagonist<br />

and is used to treat neuropathic cancer pain. However, it may cause psychotomimetic<br />

effects such as nightmares, illusions, hallucination, or delirium.<br />

We examined the effectiveness and safety of gradual dose titration of<br />

ketamine in the treatment of neuropathic pain in advanced cancer patients<br />

prospectively. Methods: After we diagnosed neuropathic pain, which did<br />

not respond to opioids in advanced cancer patients, we started ketamine<br />

10mg/24hr by continuous intravenous infusion and increased the dose by<br />

10mg/24hr every 4–6 hours before the dose exceeded 50mg/24hr. After<br />

50mg/24hr, we increased ketamine by 25mg/24hr every 12–24 hours until<br />

pain was relieved. Results: There were 15 men (62.5%) and 9 women<br />

(37.5%), with an average age of 49.2years (SD=18.4), ranging from 13 to<br />

74 years of age. The patients had a variety of tumors, with rectum cancer

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