10th World Congress on Pain, List of topics

SYMPTOM CHARACTERISTICS OF PATIENTS IN RANDOMIZED CLINICAL TRIALS IN CANCER PAIN.
N. Hagen, N. Babul Department of Medicine, Tom Baker Cancer Center, Calgary, AB, Canada , 2 Clinical Drug Development, TheraQuest Biosciences, East Norriton, PA

Aim of Investigation: To assess the characteristics of patients participating in clinical trials of opioid analgesics in cancer pain.

Methods: Randomized clinical trials of putative analgesics in cancer pain are challenging to conduct and interpret due to heterogeneity in patients, diseases and other factors. We prospectively assessed the following variables in each of six randomized clinical trials conducted by us in cancer pain: site of primary tumor, number of metastatic sites, prior scheduled and rescue opioid, pain intensity, nausea and sedation VAS scores over the course of each day, rescue use and pain characteristics.

Results: There was variability in most studied patient and pain-related characteristics within and between studies. The prevalence of different stages of pain ranged widely between studies: bone/soft tissue involvement (32-64%), visceral pain (16-49%), neuropathic contributory (9-45%) and neuropathic pain only (5-12%). Mean pain intensity recall on optimized treatment was 13-31 mm across cohorts. Sedation and nausea scores were generally stable over the course of the day, with mean nausea and sedation scores of 8-15 mm and 18-23 mm, respectively. Oral daily morphine equivalents varied 128 fold, from 30 mg to 3840 mg. The number of daily breakthrough pain episodes was generally similar across cohorts 1.0 to 1.2, although there was significant circadian variability in each cohort (53-300%), with a greater frequency of breakthrough pain during daytime hours.

Conclusions: Because of considerable heterogeneity of clinical parameters within randomized clinical trials in cancer pain, careful consideration is needed to minimize bias in their conduct and interpretation.

PALLIATIVE CARE TEAMS IN GERMANY - THE CANCER PAIN INITIATIVE MECKLENBURG-VORPOMMERN
W. Diemer, M. Meiering, J. Burchert, H.Pain Service, E.-M.-A.-University Hospital, Greifswald, Germany

Aim of Investigation: The Cancer Pain Initiative Mecklenburg-Vorpommern (M-V) is a demonstration project of the Medical Board M-V and the Pain Service, sponsored by the Federal Minister of Health. It was run 1996-2001 to improve outpatient palliative care in co-operation with general practitioners and district nurses.

Methods: A survey of 500 physicians was conducted 1997 and 1999. Quality management interventions in three counties include: (1) information for professionals, patients and relatives, (2) four quality circles (50 physicians, 12 nurses; exchange of experiences in interdisciplinary working groups), (3) a palliative care team (PCT = physician and nurse) supports the health care professionals in cancer pain therapy and palliative medicine, (4) documentation of pain treatment, palliative care and evaluation of costs.

Results: The PCT achieved 4.791 contacts to 542 patients and optimized palliative care and cancer pain (pain dropped from VAS 3.9 at rest (6.4 peak) to 2.7 (4.5) after the first visit and 2.3 (3.8) at the last visit of the PCT), parallel quality of live raised. The costs for the treatment of 500 outpatients per year at home by three clinic based PCTs are 281'000 € lower compared to the costs of frequent re-admissions to the hospital.
Conclusion: The conventional outpatient care is not sufficient for advanced cancer patients. A PCT improves palliative care, cancer pain therapy and quality of live in outpatients. It saves costs by avoiding re-admissions to the hospital. After the end of the demonstration project mid 2001 negotiations succeeded in a funding for one further year by the social security, so the PCT in Vorpommern is the first regularly working in Germany.

LONG-TERM, OPEN-LABEL, SAFETY & EFFICACY EVALUATION OF A NEW, ORAL, ONCE-DAILY, EXTENDED-RELEASE MORPHINE SULFATE FORMULATION (MORPHELAN)
D. Wynn1, R. Rauck, W. Keeton4, R. Ramirez5, C. King6, P. M. Lynch Consultants in Neurology, Wilmette, IL , 2 Piedmont Anesthesia & Pain Consultants, Winston-Salem, NC , 3 Raleigh Neurology Assoc, Raleigh, NC , 4 Dekalb Pain Center, Decatur, GA , 5 Clinical Research Co, Inc., Tamarac, FL , 6 Ligand Pharmaceuticals, Inc., San Diego, CA , 7 Elan Drug Delivery, Inc., Gainesville, GA

AIM OF INVESTIGATION: Evaluate long-term safety & efficacy of Morphelan(M) once daily in chronic moderate-to-severe, non-malignant & malignant pain.

METHODS: Patients who completed 1 of 4 prior (M) studies were included in a 1-year, open-label trial. Patients started at a (M) dose equal to their dose in the prior (M) study. Dose changes of (M), rescue drugs, and concomitant drugs were allowed. Safety assessments included adverse events, monitoring of lab values, vital signs, and physical exams. Analgesic efficacy was assessed monthly with the Brief Pain Index (BPI). The total number of rescue doses needed daily was assessed 24 hrs prior to monthly visits.

RESULTS: 137 of 284 patients completed. The median daily (M) dose was 120 mg at baseline, 180 mg at 6 mo, and remained stable from 6-12 mo. No statistically significant changes in the number of daily rescue drugs were observed from baseline to 12 mo. No clinically meaningful changes in BPI scores were seen from baseline, indicating stable analgesia. The most common AEs were nausea, constipation, and vomiting. In the majority of patients there were no clinically significant changes in lab values, vital signs, or physical exams.

CONCLUSIONS: Long-term administration of Morphelan to patients with chronic, moderate-to-severe pain requires only a single daily dose for 24 hour relief, stable analgesia, and an acceptable safety profile.

FEASIBILITY OF SUBARACHNOID CHROMAFFIN CELL ALLOGRAFT FOR TERMINAL CANCER PAIN
Z. Fu W.PAIN MENEGEMENT, SHANDONG PROVINCIAL HOSPITAL,SHANDONG UNIVERSITY HOSPITAL, JINAN, China

Aim of Investigation: To evaluate the analgesic effect and safety of subarachnoid chromaffin cell allograft for terminal cancer pain.

Methods: Ten patients with intractable cancer pain despite traditional treatments were randomly divided into two groups. In test group(n=4),2ml of the suspension chromaffin cells cultured in vitro for 3 days was injected into the subarachnoid space through lumber puncture. The same amount of cell-free culture solution was injected intrathecally in control group(n=6). Opioids were administered continuously after transplantation. The intensity of pain was assessed by VAS, the dose of opioids taken was recorded, and the catecholamine and enkephalin concentrations in cerebrospinal fluid and immune function were measured before and after transplantation.

Results: The VAS scores declined markedly in both groups after transplantation(P<0.05 or 0.01). The dose of the opioids taken by the patients in test group gradually decreased following transplantation but remained unchanged in control group. The catecholamine level in cerebrospinal fluid increased significantly, but the enkephalin level greatly decreased in both groups(P<0.01). The changes in serum levels of antibodys, complements and T-lymphocytes were all within the normal range in both groups.

Conclusions: Subarachnoid chromaffin cell allograft can produce a definite analgesia for terminal cancer pain and immune function of patients remains stable with immunosuppressant treatment, indicating that this therapeutic method is effective and safe for patients with terminal cancer pain.

Acknowledgments: Supported by grants from the State Foundation of Scientific Research of China(39570684).

THE IMPORTANCE OF VAS SCALE IN CHRONIC CANCER PAIN MONITORIZATION
L. Romanta ONCOLOGY, MEDICAL UNIVERSITY, TARGU - MURES, Romania , 2 ONCOLOGY, COUNTY HOSPITAL, TARGU-MURES, Romania

Objective: Cronic cancer pain needs monitorization by VAS scale for optimal treatment with strong opioids to obtain significant analgesic effect. We decided to enhance the importance of VAS scale in palliative care for opioid naive cancer patients.

Methods:From 2063 admisions in the Medical oncology department between 12.2000-12.2001, 448(21,7%)nedeed palliative care. From these patients 104(23,7%) had cancer pain. We used VAS scale for 38 patients opioid naive and 66 opioid treated before. Demographics of opioid naive patients: 23(60,52%)male and 15(39,47%)female with different primary cancer and metastatic cancer(lung 15,78%, liver 23,68%, bone 18,4% and 42,10% with locoregional extension.) VAS scale was used at the admision in hospital and after morphine administration from 6 to 6 hours in the first day, than once/day lasting one week.

Results: Opioid naive cancer patients had initial 7-8 pain score on VAS scale. After 1 day of morphine administration the pain was reduced significantly in 81,57% cases.13(34,2%) patients were treated with morphine inj. and 25(65,7%) by oral morphine. A number of 8 patients (21,05%) needed dose escalation in the first week.

Conclusions: VAS scale is very important for following the pain intensity and it is necessary to teach nurses and patients to use it.Following up the scores allowed monitorization of pain intensity and adaptating the dose of morphine for each patient to obtain optimal analgesic effect and better quality of life. Oral morphine was very good tolerated and had an analgesic effect in 65,7% of patients.

THE RELATIVE MILLIGRAM POTENCY RATIO OF INTRAVENOUS TO ORAL MORPHINE IN CANCER PAIN
F.A. Mahmoud. N. LeGrand, S. Davis, M. Sarhill, Walsh, D.The Harry Horvitz Center for Palliative Medicine, The Cleveland Clinic Foundation, Cleveland, OH

AIM OF INVESTIGATION: The parenteral:oral conversion ratio for morphine (M) is controversial, some suggest 1:2 others1:6. Serious underdosing or dangerous overdosing (depending on the ratio used) may occur. We conducted a prospective study to evaluate our clinical practice using an equianalgesic conversion dose of IV to oral M of 1:3.

METHODS: Consecutive admissions to an acute care palliative medicine unit were followed prospectively. Eligibility criteria: 1) IV M for pain 2) good pain control for 24 hours before conversion to oral 3) Stable co-analgesics dose for 48 hours prior to conversion and unchanged throughout the study. Pain and side effects were assessed daily before and after the conversion using numerical and categorical scales.

RESULTS: 221 consecutive admissions were screened. 87 evaluated. There were 46 males, 41 females; median age 65 years (31-83). The most common diagnosis was lung cancer (29%). All had metastatic disease. Median total daily IV dose: 41 mg (Range: 12.5-200). Median days needed to control pain using IV were 3 days (Range: 1-11). Conversion ratio used 1:3 (52 %), 1:2.5 (25 %), 1:2.25 (2 %), 1:2 (18 %), and 1:1 (3 %). Pain was either maintained or improved in 91% with the 1:3 ratio, compared to 86% and 73% for the 1:2.5 and 1:2 conversion ratios respectively.

CONCLUSIONS: 1) Most converted using the M (IV: PO) 1:3 ratio with good pain control after conversion 2) Conversions <1:3 were associated with worse pain control 3) Side effect severity was unaffected by the conversion ratio 4) The 1:3 M IV:PO relative milligram potency ratio appears correct for most patients.

EFFECTS OF A NEW ONCE-DAILY EXTENDED-RELEASE MORPHINE FORMULATION ON PHYSICAL FUNCTIONING IN PATIENTS WITH CHRONIC MODERATE-TO-SEVERE OSTEOARTHRITIS PAIN
S.H. Roth1, P. Lynch, D. Sykes3, S. Hamm, C. King41 ArthoCare, Phoenix, AZ , Gainesville Clinical Research Center, Gainesville, FL , 3 Elan Drug Delivery Inc., Gainesville, GA , 4 Ligand Pharmaceuticals Inc., San Diego, CA

AIM OF INVESTIGATION: This study assessed effects of a once-daily, extended-release, oral morphine sulfate formulation (Morphelan)(M) on physical functioning (PF). This was part of an efficacy study in patients with chronic moderate-to-severe osteoarthritis (OA) pain.

METHODS: In this randomized, double-blind (DB), placebo-controlled trial patients received either (M) 30mg QAM (n=73), M 30mg QPM (n=73), MS Contin (MSC) 15mg Q12H (n=76), or placebo Q12H (n=73) for 4 weeks (wks), could elect to enroll in a long-term (LT) extension trial receiving M QAM or M QPM, and could titrate to optimum pain control. PF was measured by the SF-36 (Short-Form) and the Western Ontario & McMaster Universities Osteoarthritis (WOMAC) index at baseline & weekly for 4 wks in the DB blind trial & wks 5, 8, 12, 18, 24, & 30 in the LT trial.

RESULTS: 184 of 295 patients completed the 4-wk study, and 86/181 completed the open-label trial. The SF-36 PF summary score significantly (p < .05) improved for the M QAM and M QPM groups at wks 1,2, & 4 and improved at all wks in the extension trial. Improvements in the WOMAC PF summary scale at wk 4 compared to baseline were as follows: M QAM (18%), M QPM (19%), MSC (14%) & placebo (8%). For the WOMAC index statistically significant improvements in PF for M were seen from wks 5-30. PF improvements through wk 12 corresponded with an increase in the mean daily M dose. After wk 12, PF was stable as was the average daily dose of M

CONCLUSIONS: Morphelan once-daily had a positive impact on PF in OA patients who completed up to 30 wks of treatment.

OPIOID ROTATION IN PALLIATIVE CARE - FREQUENCY, REASONS AND SUCCESS
H. Muller-Busch, T. Jehser1, S. Woskanjan Dep. of Anesthesiology; Pain Therapy & Palliative Medicine, GK Havelhhe, 14089 Berlin, Germany , 2 Clara Clinical Analysis, Research & Application, 14532 Kleinmachnow, Germany , 3 Palliativ-Zentrum Berlin-Brandenburg, (PZBB), 10557 Berlin, Germany

Aim of investigation: The rate of opioid rotation (OR) in palliative care has been documented in several studies between 20 and 44%. Aim of this retrospective study was to compare frequency, specific indication and efficacy for OR in in- and outpatient palliative care

Methods: The charts of over 800 patients consecutively treated between 2000 and 2001 in the palliative care unit (PCU)and pain ambulance of GK Havelhhe were screened for opioid treatment and rotation. OR was analysed according to medical reasons (insufficient analgesia and/or intolerable side effects), non medical reasons (opioid fear, compliance, economics), success rate and dose relationship. The collected data were used for a critical evaluation of the OR decisions.

Results: Opioids used in OR included morphine, fentanyl, oxycodone, hydromorphone and l-methadone. The frequency of OR was much higher in the inpatient setting compared to the ambulatory. Selection criteria for specific opioids remained unclear and depended on personal preferences. OR was based more often on medical reasons in PCU patients while in outpatients non medical reasons predominated. The success rate of OR in the PCU situation was higher although the "pain problems" here seemed to be more complex due to the state of disease.

Conclusions: OR is an useful empirically based therapeutic option but in decision making medical and non medical reasons should be taken into account carefully. More clinical research is needed to find out specific indications for the different opioids.

Acknowledgement: The study was sponsored by Mundipharma, Limburg, Germany

FACTORS ASSOCIATED WITH PATIENTS SATISFACTION IN AMBULATORY PALLIATIVE CARE
J. Moyano, Anesthesia, Clinica de dolor, Fundacion Santa fe, Bogota, Colombia

AIM OF INVESTIGATION: To grade aspects related to users' satisfaction such as kindness, comfort, punctuality, effectiveness

METHODS: 262 patients who attended an outpatient palliative care consultation (National Cancer Institute) were interviewed by someone who did not take care of the patient directly. The patients answered a 23 open question test

RESULTS: Appropriate information on: different approaches to treatment, 87.8% the condition and progression of their illness 85.1% how to take the medications 94.7%. Patients considered the treatment effective in the control of symptoms 71.8%; 55.3% waited over an hour in the waiting room. Positive opinion on the doctor's manner 87.4%. No information on: undesirable side effects of the treatment 38.5%, waiting time 13.8%. Patients and their families questioned independently, considered themselves satisfied with the service 95.4%. 95.8% would use the services again. We found a correlation between explanations about the disease and effectiveness for symptom relief (Pearson chi2 31.72).

CONCLUSIONS: With regards to the effectiveness of the treatment, almost a third point out lack of improvement, which again contrasts with the patient's and family's global satisfaction indicating that other factors are more important in the final assessment. We have found that the main factor involved was the information about the disease. In conclusion the users and their families were satisfied with the service, to improve this service further it is imperative to provide more extensive information on the stage of the disease, treatment options, side effects and provide more information on internal administrative procedures.

FEAR OF ADDICTION IN A PALLIATIVE CARE POPULATION.
C. Guerrero J.Anesthesia, Clinica de Dolor y Cuidado Paliativo, Fundacion Santafe, Bogota, Colombia

Objectives: To evaluate related factors with the fear of opioid addiction

Material and Methods: A survey of 21 multiple selection questions in 110 outpatients, with severe cancer pain, regular opioid analgesia and normal cognitive status.
Results Prevalence of fear 52. The main correlation found, although weak, Pearson chi2 12.95 was between the family and individuals fear of opioid addiction. There were no significant differences for sex, age, education, origin, occupation, religion, civil status, diagnoses and individual or family background diagnoses of psychopathology, alcoholism or drug addiction. The negative thoughts with regard to the morphine were correlated positively with the fear of addiction..

Discussion An open communication constitutes the best means to show the kindness of the opioid analgesia. Discussion of fears from patients and their families will warrant better results. In this study the main external factor is the family negative attitude with regard to the morphine. These families and their sick relatives show from the beginning negative thoughts about the morphine. Misconceptions in societies like ours in which at general level, it doesnt exist a clear distinction between the illegal drugs and the morphine may play a role.

Conclusion: The education aimed to the patient and the family around this fear should be a pre-requisite to begin the opioid analgesia .It deserves special attention to patients who begin the treatment with morphine due to the biggest prejudices with relationship to this drug

CELIAC PLEXUS NEUROLYTIC BLOCK FOR INTRACTABLE PAIN OF UPPER ABDOMINAL MALIGNANCY: COMPARISON OF SINGLE NEEDLE TRANSAORTIC VERSUS TWO NEEDLE CLASSIC RETROCRURAL APPROACH.
P. Jain V. Kumra, V.P Anaethesiology and pain management, Sir Ganga Ram Hospital, New Delhi, India

Aim of Investigation: To compare the efficacy and morbidity of transaortic versus classic retrocrural technique of celiac plexus neurolytic block (CPNB) in patients with intractable pain due to upper abdominal malignancy.

Methods: Forty-five consecutive patients with upper abdominal malignancy such as carcinoma of head of the pancreas, kidney, gall bladder and stomach were studied. All patients were referred to the pain relief clinic with moderate to severe pain not responding to conventional analgesic therapy. Those patients with visual analogue score (VAS) more than five were studied. They were randomly divided into two groups. Group A (n = 22) patients received CPNB with 15 ml of 50% alcohol via each needle by the classic retrocrural approach. Group B (n=23) patients received CPNB with 20ml of 50% alcohol by the transaortic single needle technique. Both the techniques were performed under fluoroscopic control using radio contrast dye. Pain relief was assessed objectively by visual analogue score. Other parameters such as appetite, sleep, analgesic requirements, nausea, vomiting and psycho-behavioral changes were also recorded on a 4-point scale.

Results: 68.1% of patients in group A and 60.8% of patients in group B had good pain relief (VAS<3) 72 hours after the block. Operative mortality was nil with the two techniques. No major complications were recorded in either group but immediate hypotension (< 70mm Hg systolic BP) was seen more with the classic retrocrural approach.

Conclusions: Transaortic approach of CPNB is equally effective with fewer incidences of immediate complications and can be preferred over classic retrocrural approach.

TRANSDERMAL FENTANYL - OUR INITIAL EXPERIENCE
S. Nayak M.B. Syasamal, T. Senapati, S.N. Singh, D.N. Das, R.Anaesthesiology, Pain Relief & palliative Care, A.H. Regional Cancer Centre, Cuttack, India

Aim: - To present the initial result of using the transdermal Fentanyl (Durogesic) patch during the last 6 months in our Centre.

Methods: - 76 cancer patients with advanced disease receiving any kind of opioids were included in our study. Previous opioid treatment, Fentanyl dosages, duration of use were analysed. The rate of success, side effects, reasons of withdrawal and cost effectiveness were also analysed.

Results: - Out of 75 patients 46 were male and the rest female. All were adult the age ranging from 23 to 56. The dosing was either 25 mcg/hr. or 25 mcg/hr. The correct dosage was arrived at by dividing the previous dose of oral morphine in 24 hours by 3.6. The adequate analgesia provides a much better quality of life even in the last few hours. 7 of our patients continued attending to their job until 4 weeks before death. We had 46 patients who preferred this method to oral medication. There was initial drowsiness in 12 cases, which lasted for more than 72 hours and improved there after. One patient fainted after the daughter left the patient basking in the morning sun. She was advised not to give a hot shower in the area of patch. Fentanyl patch is well tolerated with minimal side effect and has a wide patient acceptance. The fact that it is 10 /3 times more costly than immediate release/continuous release oral morphine, may have some public health deterrent effect in developing economies like India.

Conclusion: -- Transdermal Fentanyl is safe and effective. There is a need to warn about exposure to heat and sunlight.

PILOT STUDY OF BOLUS INTRANASAL SUFENTANIL AS 'TOP UP' OPIOID IN A HOSPITAL PALLIATIVE CARE UNIT
M.A. Ashby P. Bush, S. Keech, J. Jackson, K Palliative Care Centre, Monash Medical Centre, CLAYTON, VIC, Australia

AIMS: Demonstrate efficacy, safety, and patient satisfaction with the administration of intranasal sufentanil to patients requiring top-up boluses whilst receiving regular opioids for cancer pain.

METHODS: Consenting patients were offered intranasal sufentanil in place of their prescribed top-up opioid bolus (usually oral or subcutaneous morphine) for one episode of breakthrough or incident pain per day.

A patient-controlled intranasal (PCINA) device (manufactured and supplied free of charge by Go Medical) was used; each spray application delivers a volume of 0.18 ml.

Starting dose was 4.5 mcg, repeated at 10 and 20 mins if needed. If ineffective at 30 mins the usual top-up medication was given, and the next sufentanil dose, if needed, was doubled (with a ceiling dose of 36 mcg x 3). Verbal rating pain scores (VRS), drowsiness scores, respiratory rate and oxygen saturation were recorded for next 2 hrs. Each episode was analysed individually for response, time to response, adverse effects and patient preference

RESULTS: Good pain relief lasting about two hours occurred in 5 out of 7 episodes in the 4 patients recruited so far (to February 2002). Responding patients rated IN sufentanil as giving faster onset and superior relief to their usual top-up. The maximal dose administered was 9mcg x 3. No adverse effects have been seen.

CONCLUSIONS: These pilot data show that IN sufentanil was safe and effective in this dose range and has considerable potential as a top-up agent. A multicentre study is being developed.

KETAMINE IN THE CONTROL OF GRADE 4 ODYNOPHAGIA ASSOCIATED WITH CHEMO/RADIOTHERAPY INDUCED MUCOSITIS
K. Jackson1 P. Bush, S. Ashby, M.Palliative Care Centre, Monash Medical Centre, CLAYTON, VIC, Australia

AIMS: To assess the efficacy of continuous subcutaneous infusion (CSCI) ketamine in the control of grade 4 odynophagia (painful swallowing) from chemo/radiotherapy induced mucositis.

METHODS: Open label audit of oncology inpatients referred to a palliative care consult service because of refractory pain associated with NCI CTC grade 4 odynophagia (cannot swallow saliva) secondary to oro-pharyngo-oesophageal chemo/radiotherapy induced mucositis. Data collected: patient assessed VRS pain scores, maintenance and breakthrough opioids, 24 hr ketamine and oral intake. Ketamine started at 100 mg/24 hrs with escalation to a maximum of 500 mg/24hrs if required. Concurrent topical and opioid analgesics continued unchanged. Primary analysis pain relief with secondary criteria of (i) Improvement in function and (ii) significant opioid dose reduction.

RESULTS: All eight patients from June 1998 to 2001 achieved a 50 % or greater reduction in mean VRS, with significant improvement in oral intake. Four achieved a 50 % or greater reduction in 24 hr opioid and/or number of opioid breakthroughs in 24 hrs. The maximum ketamine dose administered was 300 mg/24hrs and the longest infusion time was five days.

CONCLUSION: This small study shows a high response rate to ketamine for mucositis induced odynophagia. This common complication of cancer treatment results in a high level of morbidity, and may lead to disruption of radiotherapy and chemotherapy schedules, with the consequent potential for poorer disease control. As response to currently advocated symptomatic measures, including opioid infusion, is often poor, early consideration of ketamine is recommended.

CHANGE TO METHADON IN CANCER AND NON-CANCER- PAIN BY THE USE OF KETAMINE TESTING NMDA- BLOCKADE AND "BRIDGING" THE METHADON- ONSET? PROPOSAL FOR A FIXED SCHEDULE IN CLINICAL PRACTICE
S.J. Eychmueller P. Russenberger, R Pain/ Palliative Care, Kantonsspital, St. Gallen, Switzerland

Aim of the investigation: To evaluate if ketamine as immediate acting NMDA- blocking agent may help a) to avoid ineffective change to methadon and b) may serve as "bridging" agent for the first few days of methadon use. Background: Unclear how to change effectively and "smooth" from other opioids to methadone

Methods: in 07- 12/2001 we changed patients with intractable pain under various opioids to methadone immediately (Group A) or by using ketamine in a fixed schedule (Group B): Day 1) continue other opioid, start Ketamine 24 hours; Day 2) if effective reduce other opioid 50%, start methadone 10% of initial oral morphin dose, continue ketamine; Day 3) continue ketamine, discontinue other opioid; Day 4)discontinue ketamine + calculate methadone/ day (3 doses, after 2 days 2 doses). Pain intensity was assessed daily during rotation, and dosage of methadon on day 1 and 5 was documented.

Results: 14 patients were included: first 6 patients were changed without Ketamine (Group A), then 8 with Ketamine (Group B): reduced pain intensity was found in 11/14 patients with sudden onset of effect in Group B (7/8 day 1) and prolonged in Group A (1 to 4 days); Ketamine was well tolerated in 7/8 patients (discontinued in 1 patient due to massive drowsiness). The initially calculated dosage of methadone stayed unchanged in 6 patients, increase 50% in 1, and reduction 30% in 1 patient. Dose- escalation in 4/6 patients in group A (range 50 150%) from day 1 to 5.

Conclusions: The use of ketamine in small doses (10 mg/h SC) in a standardised way seems to be safe and helpful for "testing" (better pain control) AND "bridging" methadone (sudden onset).

PAIN AND PAIN TREATMENT IN PALLIATIVE IN-PATIENT CARE IN GERMANY
G. Lindena, F. Nauck3, C. Ostgathe CLARA, Clinical Research, Kleinmachnow, Germany , 2 Pain Clinic, Pain Ambulance, Dept of Anesthesiology, University, Cologne, Germany , 3 Centre for Palliative Care, Malteser KH, Bonn, Germany

Aim of Investigation: Pain is the most frequent symptom in patients admitted to palliative care units. As patients are multimorbid and / or in a terminal state, treatment failures may be more frequent than in other settings. This paper analyses the pain situation, analgesic therapy and its efficacy in palliative care units in Germany.

Methods: Starting May 2001 the palliative care units used a consented core documentation sheet to document consecutively up to 30 of their patients at admission and before discharge or death. Additionally, in many units a self-assessment form for pain and other symptoms was offered to the patients.

Results: In 57 palliative care units (55 Germany, 1 Suisse, 1 Austria) 1304 patients were included, 96.9% with cancer diagnoses. Of these patients 518 had severe or most severe pain, 64.4% of them treated with step III opioids before admission. During inpatient stay the dosage was escalated for most patients, coanalgesics were added (admission 26.0% to inpatient stay 48.7%) and 22.5% of the patients changed to a step III opioid. A switch between step III opioids was done only rarely. With these measures pain improved to no pain (27.4%), mild (52.3%) or moderate (15.8%) pain. The mean difference was 1.56 on a 5-point scale, but showing differences between the centres. Unrelieved pain was reported for only 22 (4.2%) patients

Conclusions: Adequate pain relief was achieved for 95.8% of patients with severe and most severe pain at admission to the palliative care unit

Acknowledgements: This project was supported by Mundipharma GmbH, Limburg Germany and the German Cancer Society, Frankfurt.

EPIDURAL STEROIDS IN PALLIATIVE CARE: AN EFFECTIVE ADDITIONAL STEP IN PAIN TREATMENT
B.C. Verdouw, M.F. Wagemans, N.T. van Dasselaar2, W.W. Zuurmond Department of Anesthesiology, Reinier de Graaf Groep, Delft, Netherlands , 2 Department of Anesthesiology, Leiden University Medical Center, Leiden, Netherlands , 3 Department of Anesthesiology, Academic Hospital Vrije Universiteit, Amsterdam, Netherlands

Aim of Investigation: To analyse epidural steroids as an additional step in palliative pain treatment.

Methods: Cancer pain patients with insufficient effect of oral and transdermal opioids or suffering intolerable side-effects may next be treated with either opioid rotation or subcutaneous or spinal opioids with the use of indwelling catheters and pumps. To adjourn this moment of changing therapy, these patients were injected with epidural methylprednisolone to relieve the pain. Patients were given appointments every 2-4 weeks, but were instructed to call and come when the pain returned or increased.

Results: Seven patients (age 50-81) were treated. At the moment of increasing pain these patients received 160 mg methylprednisolone epidurally. Patients had metastases of bone, abdominal glands and liver. Pain localisations were vertebral column, hip and abdomen. Mean time between epidural injections was 4 weeks. The treatment period varied between 1 and 15 months. The dose of transdermal fentanyl didnot increase and remained between 50-200 mcg. One patient had 100 mg of sustained release morphine. After nine months of concomitant treatment with epidural steroids, one patient had an intrathecal catheter with bupivacaine and morphine during the last 20 days.

Conclusions: In our patients, epidural steroids every 4 weeks adjourned the decision to increase the doses of opioids and reduced the indication for opioid rotation, subcutaneous and spinal catheter techniques.

PALLIATION OF PAINFUL BONE METASTASES BY TWO DIFFERENT SHORT-COURSE RADIOTHERAPY SCHEMES
M.D. Suarez, J. Artiles1, J.C. Martnez, C. Fuentes, A. Villar11 Department of Radiotherapeutic Oncology, Hospital La Candelaria, Santa Cruz de Tenerife, Spain , 2 Research Unit, Hospital La Candelaria, Santa Cruz de Tenerife, Spain

Aim of investigation :To compare the effects on pain alleviation, opioids requirements and quality of life (QOL) of two radiotherapeutic short-course schemes in patients with severe metastatic bone pain

Methods: Thirty-four adults were enrolled in this prospective randomized trial. Selection criteria were: severe pain from a solitary bone metastase, no radiological signs of fracture, no previous radiotherapeutic palliation, no visceral metastases, and no concomitant chemotherapy. Fifteen patients received 20 Gy in 1 week (5 consecutive fractions) and 19 received 30 Gy in 2 weeks (5 fractions per week) from a Co60 source. Assessments (pain, QOL) were performed before treatment and 2 weeks afterward, using the Radiation Therapy Oncology Group (RTOG) and EuroQoL scales, respectively. Recommendations from the Declaration of Helsinki were followed.

Results: Both groups were comparable in demographic characteristics, site of metastases, and basal QOL and pain scores. Significant improvements of QOL (P< 0.05), and significant reductions of pain (P< 0.001) were observed for both groups after treatment, with no significant post-treatment differences between groups for comparisons of scores. Opioid doses were reduced in 6 cases, increased in 2 and remained unchanged in 26. Median survival time was 7 months. No radiation retreatment was needed, and no fracture developped during the follow-up period

Conclusions: both radiotherapeutic schemes attained a similar level of palliation, in spite of the differences in dose and fractionation.

Acknowledgments: Supported by grant from Funcis, Canary Islands Autonomic Government

THE EFFECT OF NEUROLYTIC CELIAC PLEXUS BLOCK ON PAIN RELIEF, QUALITY OF LIFE, AND SURVIVAL IN PATIENTS WITH UNRESECTABLE PANCREATIC CANCER: A PROSPECTIVE, DOUBLE BLINDED, RANDOMIZED CLINICAL TRIAL
G.Y. Wong, D.R. Schroeder, P.E. Carns, A.E. Baumgartner1, M. Pancreatic Cancer Pain Study Team11 Anesthesiology, Mayo Clinic, Rochester, MN , 2 Biostatistics, Mayo Clinic, Rochester, MN

AIM OF INVESTIGATION: To test the hypothesis that neurolytic celiac plexus block (NCPB) improves pain relief, quality of life (QOL), and survival in unresectable pancreatic cancer patients compared to opioids alone.

METHODS: Following IRB approval, 100 eligible pancreatic cancer patients with significant pain were randomized to receive a blinded injection: NCPB vs sham. All patients could receive opioids with the WHO ladder by a blinded clinician. Pain intensity (0-10 NRS), opioid consumption/side effects, and QOL (FACT-PA) were assessed weekly by a blinded observer. Statistics involved cox proportional hazards regression, repeated measures analysis, and the chi-square test.

RESULTS: Baseline pain was similar between NCPB and sham groups (4.41.7 and 4.11.8 respectively). At week 1, pain (2.11.4 and 2.72.1 respectively) and QOL were both significantly (p<0.001) improved, with a larger pain decrease in NCPB compared to sham (p=0.037). From repeated measures analysis, pain was significantly lower (p=0.009) for NCPB vs sham over time. However following randomization, opioid consumption (p=0.86), frequency of opioid side effects (all p>0.10), QOL (p=0.66), and overall survival (p=0.27) did not significantly differ between groups.

CONCLUSIONS: These results suggest NCPB can improve pain relief in pancreatic cancer patients with significant pain compared to optimized opioid therapy. However, NCPB does not affect opioid consumption, QOL, or survival.

ACKNOWLEDGMENTS: FAER, Mayo Psychosocial Oncology Program, Mayo ACRU, and Mayo Clinic and Foundation

10th World Congress on Pain, List of topics

10th World Congress on Pain. International Association for the Study of Pain, San Diego, California, USA August 17-22, 2002