The Assessment of Cancer Pain Treatment Using the Pain Management Index in Hospitalized Patients with Cancer. A Pilot Study

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1 original studies The Assessment of Cancer Pain Treatment Using the Pain Management Index in Hospitalized Patients with Cancer. A Pilot Study Ramona Palalogos 1, Alexandru Mocanu 1, Loredana Balacescu 1, Ariana Nemes, Robert Rajcsanyi, Tobias Jozsef 3, Calin Cainap 1, Claudia Burz 1 1) Department of Chemotherapy of Ion Chiricuta Institute; ) Clinical Hospital; 3) Gastrointestinal Institute Octavian Fodor, Cluj-Napoca Pain is a frequent symptom in oncological practice frequently being the first symptom of a tumor. The pain management index is a score linking the severity of pain with the medication recommended to treat it. Objectives The purpose of this study was to understand the cancer related-pain depending on sociodemographic characteristics of the patients, tumor sites and tumor stage and to assess the prevalence of inadequate pain management. Methods Fifty-three patients, with different tumor sites and stages were analyzed for patient-rated pain scores (EVA -1 scale), pain type and analgesic treatment. Pain scores were assigned, 1,, and 3 when patients reported no pain (), mild (EVA 1-3), moderate (EVA -7), or severe pain (8-1), respectively. Analgesic scores of, 1,, and 3 were assigned when patients had no pain medication, nonopioids, weak opioids, and strong opioids. The pain management index (PMI) was calculated by subtracting the pain score from the analgesic score. A negative PMI score was considered an indicator of potentially inadequate pain treatment. Results Of 53 patients included in the study the pain was the first symptom for 3 patients (81.13%) from whom.5% suffered moderate-to-severe pain. The pain was neuropathic in.93% cases, nociceptive in 37. % and mixed in 1.8.%. The tumor stage correlates with pain intensity (p=.). A negative PMI reflected the undertreatment of cancer pain was calculated for 7 patients (.79%). Conclusions There are no correlations between the pain syndrome and sociodemographic characteristics of patients. The intensity of pain correlates only with tumor stage. The treatment of cancer pain remains suboptimal despite publication of numerous cancer pain management guidelines. Key worlds : cancer, pain, pain management index PMI Introduction Pain is a important health care problem for patients with cancer being reported in 17 to 7% of patients with different stages of disease [1,] The World Health Organization (WHO) developed guidelines for the treatment of cancer pain depending on pain severity which suggest the prescription of nonsteroidal anti-inflammatory drug (NSAID) for mild pain, weak opioid (codeine, Tramal) for moderate pain while so-called strong opioid (morphine) are reserved for severe pain [3]. Besides the OMS recommendations there are also other guidelines for cancer pain management including the Agency for Health Care Policy and Research (AHCPR) [] and the Expert, Working Group of the European Association for the Palliative Care [5, ]. The Pain Management Index (PMI) is a score linking the intensity of pain to the analgesic treatment as a measure of treatment adequacy for cancer pain. It was developed by Cleeland et al in 199 and since Journal of Radiotheraphy & Medical Oncology December 1 Vol. XVII No : -8 Address for correspondence: Claudia Burz Department of Chemotherapy of Ion Chiricuta Institute Cluj-Napoca Romania cburz@yahoo.fr then other variants were proposed [7]. The undertreatment of cancer pain is well documented worldwide involving between 5 to 7% of patients despite the elaboration of several guidelines for cancer pain management being attributed to many factors depending either on health care provider or patients, family and society [8]. The objectives of this study are to identify and describe the pain syndrome in patients who presented with different cancer types for understanding the epidemiology of the phenomenon. The estimation of the prevalence of inadequate cancer management by calculating PMI was another objective of our study. Materials and methods The study was conducted on a total of 53 patients, who had presented to Cancer Institute I Chiricuta, Cluj-Napoca for different malignancies between March to May 1. All patients wrote an informed consent. The following sociodemographic and medical variables were collected from all participating patients: age, gender, site of cancer, tumor stage and analgesic treatment Measures The evaluation of the pain syndrome was performed

2 The assessment of cancer pain treatment using the pain management index in hospitalized patients with cancer 5 using a unidimensional methods for pain intensity (visual analogue scale VAS which consists of a 1 cm ruler, having an extremity that indicates absence of pain and the other extremity that indicates extreme, unbearable pain) [9]. Projection of pain on the silhouette and language questioner were assessed for the evaluation of pain type and localization (Fig. 1) [1]. Fig. 1. Projection of pain on the siluette and language questioner (knife in the wound; prick; sting; pulsate; cramps; tingling; deep; irritating; depressing; permanent). Depending on the intensity of pain, we established four groups of intensity. The first group included patients with no pain (EVA ), the second group with mild pain (EVA 1-3), the third group includes patients with moderate pain (EVA between and 7) and the fourth group includes patients with intense pain at presentation (EVA between 8 and 1). A pain score of defined an absence of pain (EVA ), 1 was for mild pain (1-3), for moderate pain (-7), and 3 for severe pain (8-1) [11]. Analgesics Each patient was asked for the drugs used for analgesia which were categorized as WHO Step 1 (nonsteroidal antiinflammatory drugs), WHO Step (tramadol, codeine), WHO Step 3 (morphine). Patients were further asked if they were administered any of the adjuvant analgesics drugs. No prescribed analgesic was scored as, a nonopioid as 1, a weak opioid as, and a strong opioid was scored as 3 [1]. Subsequently we determined the Pain Management Index (PMI) by subtracting the pain score from the analgesic score. A negative PMI score was considered an indicator of potentially inadequate pain management by the prescriber [7]. Statistics Descriptive statistics were used to establish the correlation between pain intensity and age, sex, primary tumor site and stage. Reported P-values were considered significant at the P <.5 level. Results Socio-demographic and medical variables of patients Between March to May 1 fifty-three patients were included in the study. Twenty patients were males (37,735%) and 33 patients were women (.%). The average age of patients in the study was 57.8 years (minimum age = years, maximum age = 79 years) with four patients aged between and years, 7 patients between 1 and 5 years and patients over 5 years. Depending on the primary tumor site, 1 patients presented with genital tumors (11 patients with ovarian carcinoma ; patients with endometrial carcinoma, 1 patient with cervix carcinoma,), 17 patients had gastrointestinal cancers ( patients pancreas cancer; 8 patients with colon carcinoma, patients gastric carcinoma; 1 patient with gallbladder cancer, 1 patient with esophagus carcinoma, 1 patient with abdominal mesothelioma), 7 patients had breast cancer, patients with head and neck cancer, patients with bronhopulmonary cancer, 1 patient with follicular lymphoma and two patients were diagnosed with undifferentiated carcinoma of unknown primary. The majority of patients (8%, 3 patients) were diagnosed in stage IV, followed by stage III in % of patients (11 patients), while 1% of patients were with stage II (5 patients). Regarding the frequency of metastases, liver metastases were presented at patients, patients had bone metastasis, pulmonary, 7 patients peritoneal carcinomatosis while patients were presented with disseminated metastasis (Table I). Prevalence and intensity of pain Depending on the intensity of pain the patients were grouped in four groups as described in materials and methods. 1 patients had no pain; 1 patients reported mild pain (18.8%); patients (1.5%) moderate pain and 11 patients reported severe pain. Regarding the type of pain, nociceptive pain was perceived in 1 patients (37.%), neuropathic pain in 9 patients (.93%), while 18 patients experimented mixed pain (1.8%). In terms of treatment, patients (%) were treated with first line of treatment described by OMS; 3% (1 patients) of patients were treated with second line, patients had co-analgesics associated while 5 patients had no treatment for pain (Table I). No association was observed between intensity of pain (EVA) and type of pain (χ = 1.53, p=.799), EVA and sex of the patients (χ = 1.971, p=.373), EVA and age of the patients (χ =.358, p=.81) (Table II). A strong correlation was observed between intensity of pain (absent/ mild vs moderate/severe and stage of disease (χ = 15.5, p=.) (Fig ).

3 Palalogos et al Table I. Socio-demographic and medical variables of patients Study characteristics Sex Male Women Median age - years 1-5 years > 5 years Primary sites Stage Genital tumors Gastrointestinal cancers Breast cancer Head and neck cancer Bronhopulmonary cancer Follicular lymphoma Carcinoma without starting point No. patients Table II. The significance of the association between EVA and type of pain, sex, age of the patients was tested using χ test. A p value <.5 was considered significant. Type of pain Sex Age χ p χ p χ p EVA Sig. ns ns ns The analgesic score was for 5 patients, 1 in cases and for 1 patients The PMI index calculated was - for 1 patients, -1 for 17 patients, for 1 patients, 1 for patients, being negative for 7 patients (.79%) (Fig. 3). no. patients I II III IV Metastasis Bone metastases Liver metastasis Pulmonary metastases Peritoneal carcinomatosis Multiple metastasis Pain Intensity Pain management index EVA EVA 1-3 EVA -7 EVA 8-1 Pain type Neuropathic Nociceptive Mixt Treatment 15 1 OMS 1 OMS OMS 3 Co-analgesics No treatment 5 stg1- stg3 stg absent/mild moderate/severe Fig.. Correlation between pain s intensity (absent/mild = -, moderate/severe= 5-1 ) vs std. bolii (χ = 15.5, p=.). Fig. 3. Adequacy of treatment evaluated by pain management index. Discussion Pain is a frequent symptom in oncology, as it is found in 7% of the cases, being frequently the first symptom of a tumor. Regardless of its cause, pain must be prevented and treated as a priority and considered as an independent part of the treatment. Regarding the mechanism of production, there is nociceptive pain produced by the activation of nociceptors by inflammatory substances (serotonin, P substance, bradikinin, prostaglandines, histamin), released because of mechanical, thermal or chemical stimulation and neuropathic pain caused by the injury of the nervous fibers. The complex nature of pain justifies the importance of evaluating the patient as a whole, not only of the pain syndrome. Before treating the pain, it is indispensable to know elements such as: - History of the pain: when and how it started, contributing factors, temporary or continous, frequence and length of the pain episodes, analgetics that have been used and their efficiency. - Topography, intensity and type of pain ( neuropathic, nociceptive, mixt) - Psycho-social, emotional and cognitive impact - Clinical and paralinical evaluation examination:

4 The assessment of cancer pain treatment using the pain management index in hospitalized patients with cancer 7 searching for areas with shortage of sensitive or motor functions, paresthesia, allodynia (pain produced by a stimuli that normally does not produce pain), hyperalgia (exagerated pain produced by a normal pain stimuli), suggesting nervous injury. Regarding the evaluation and treatment of pain, OMS recommends: believe the symptoms described by the patient; evaluate all aspects of pain; evaluate the patient s mental condition; physical examination of the patient; complementary examinations; pain treatment in order to facilitate the examinations; evaluate the extent of the cancerous disease; continuous reevaluation of the analgesic treatment. Currently there are two methods for pain evaluation. One is unidimentional, simple, repeatable Simple Verbal Scale (SVS), Visual Analog Scale (VAS), Numeric Scale (NS), which evaluates only the pain intensity and complex multidimensional methods which associates language (R.Melzack), anxiety and depression (HAD) questionnaires, projecting of pain on the silhouette [1]. Based on the intensity of the pain, OMS describes three lines of analgesic treatment. First line, used in mild pain (EVA= 1-) with the main agents Paracetamol and NSAIDs (Diclofenac, Indometacin, Ibuprofen, Paduden, Fenilbutazon, etc). Second line, for the treatment of moderate pain (EVA= 5-7) resistant to first line agents. Among the drugs used in the second line are codein, dihydrocodein (DHC), combined drugs (codein-paracetamol), Tramadol. Third line treatment with the main agent Morphine. Co-analgetics represent adjuvant drugs that can be associated to classical analgetics in any treatment line such as antidepressants, antiepileptics, or competitive inhibitors of NMDA-receptors, corticosteroids, biphosphonates, antispastics. The efficacy of treatment should be evaluated by calculating the Pain Management Index (PMI). PMI was developed in the past 1 years as a tool for evaluating the quality of analgesic prescriptions by subtracting the pain score from the analgesic score. A negative PMI score was considered an indicator of potentially inadequate pain treatment [13,1]. Over 7 % of patients with cancer experience moderate to severe pain during their illness and despite many guidelines for pain management, only a small proportion of patients receive adequate analgesia. Cancer pain management is a complex pain syndrome including sensitive-sensorial, cognitive, emotional and behavioral aspects. In our study, from 5 patients the pain was the first symptom for 3 patients (81.13%) from whom.5% suffered moderate-to-severe pain. The pain was neuropathic in.93% cases, nociceptive in 37. % and mixed in 1.8.%. The intensity of pain correlated only with tumor stage (p=.). There is no correlation in our study between the others sociodemographic and medical variables of patients as age, sexe, type of pain or primary site and intensity of pain which could be explained by the limited number of patients. A negative PMI reflected the undertreatment of cancer pain was calculated for 7 patients (.79%). Regarding the literature there are several studies regarding the efficacy of analgesics prescription in pain related cancer with a negative PMI varying from 13% in Germany to 79% in India (Table III). Table III. Adequacy of treatment among others studies (PMI) Reference (Country) n % Inadequate treatment 95% CI Sabatowski(Germany)[15] Uki (Japan) [1] Wells (USA) [17] Cascinu (Italy) [18] Laruc (France) [19] Cleeland (USA) [] Mystakidou (Greece) [1] Saxena (India) [] The undertreatment of pain-related cancer is worldwide depending on many socioeconomic reasons. For example, the culture of patients, access to doctor, patients frequently do not communicate the intensity of their pain, the reluctance for physicians to prescribe and patients to use opioids because of their known side effects [3]. These obstacles should be overcome by emphasizing the importance of pain control in cancer patients, a good evaluation of pain syndrome depending on the etiology of pain, pain intensity using pain assessment tools routinely either for initial evaluation as for treatment efficacy, ensuring adequate information regarding opioide and other analgesic administration. References 1. Portenoy RK, Lesage P. 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