Ann Oncol 2012 Ripamonti Vii139 54 | Opioid | Analgesic

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  Management of cancer pain: ESMO Clinical PracticeGuidelines † C. I. Ripamonti 1 , D. Santini 2 , E. Maranzano 3 , M. Berti 4 & F. Roila 5 , on behalf of the ESMOGuidelines Working Group* 1 Supportive Care in Cancer Unit, Fondazione IRCCS, Istituto Nazionale Tumori, Milan, Italy;  2 Oncologia Medica, Università Campus Bio-Medico, Rome, Italy; 3 Department of Oncology, Radiation Oncology Centre, S. Maria Hospital, Terni, Italy;  4  Anaesthesiology Intensive Care and Pain Therapy, University Hospital Parma,Parma, Italy;  5 Department of Medical Oncology, S. Maria Hospital, Terni, Italy  incidence of pain According to a systematic review of the literature, painprevalence ranges from 33% in patients after curative treatmentto 59% in patients on anticancer treatment and to 64% inpatients with metastatic, advanced or terminal phase [1]. Nodifference in pain prevalence was found between patientsundergoing anticancer treatment and those in an advanced orterminal phase of the disease [1]. Factors in 󿬂 uencing thedevelopment of chronic pain in cancer survivors who havecompleted treatment include peripheral neuropathy due tochemotherapy, radiation-induced brachial plexopathy, chronicpelvic pain secondary to radiation and postsurgical pain [2].Pain has a high prevalence in speci 󿬁 c cancer types such aspancreatic (44%) and head and neck cancer (40%) [3].Moreover, another systematic review of the literature showedthat nearly half of cancer patients were under-treated, with ahigh variability across study designs and clinical settings [4].Recent studies conducted both in Italy and pan European [5,6] con 󿬁 rmed these data, showing that different types of pain orpain syndromes [7, 8] were present in all phases of cancer (early and metastatic) (Table 1) and were not adequately treated in a signi 󿬁 cant percentage of patients, ranging from56% to 82.3%. In a prospective study [9], the adequacy of analgesic care of cancer patients was assessed by means of thePain Management Index in 1802 valid cases of in- andoutpatients with advanced/metastatic solid tumors enrolled atcenters speci 󿬁 cally devoted to cancer and/or pain management(oncology/pain/palliative centers or hospices). The study showed that, even in these centers, patients were still classi 󿬁 edas potentially under-treated in 9.8% – 55.3% of the cases.Contrary to the percentage of incidence of pain reported inhematologic patients in past literature, a signi 󿬁 cant proportionof patients with lymphoma and leukemia may suffer from painnot only in the last months of life (83%) [5, 10], but also at the time of diagnosis and during active treatment [10].Despite published guidelines and educational programs onthe assessment and treatment of cancer-related pain, in any stage of oncological disease, unrelieved pain continues to be asubstantial worldwide public health concern in patients witheither solid or hematological malignancies. Cancer-related painmay be presented as a major issue of healthcare systemsworldwide if we consider that the incidence of cancer was12.667.470 new cases in 2008 and, based on projections, it willbe >15 million in 2020 [11]. assessment of patients with pain Initial and ongoing assessment of pain and of patients withpain at any disease stage should clarify both the need foradditional comprehensive evaluation and a rational plan of care. Table 2 presents the guidelines for the adequateassessment of patients with pain. The proper and regular self-reporting assessment of pain intensity (PI) with the help of  validated assessment tools is the  󿬁 rst step towards effective andindividualized treatment. The most frequently usedstandardized scales [12] are reported in Figure 1 and are visual analogue scales (VAS), the verbal rating scale (VRS) and thenumerical rating scale (NRS).The assessment of the quality of pain improves the choice of the therapy: pain is termed nociceptive when it is caused by ongoing tissue damage, either somatic or visceral orneuropathic, if sustained by damage or dysfunction in thenervous system (Table 1) [2]. According to the literature, most patients with advanced cancer have at least two types of cancer-related pain which derives from a variety of etiologies[7, 10]. Sixty-nine percent of patients rate their worst pain at a level that impaired their ability to function [13]. recommendation The intensity of pain and the treatment outcomes should beregularly assessed using (i) VAS, or (ii) VRS or (iii) the NRS [V, D].In older age, the presence of limited communicative skills orof cognitive impairment such as during the last days of life †  Approved by the ESMO Guidelines Working Group: December 2004, last update June2012. This publication supersedes the previously published version —  Ann Oncol 2011;22 (Suppl 6): vi69 – vi77.* Correspondence to : ESMO Guidelines Working Group, ESMO Head Of  󿬁 ce, ViaL. Taddei 4, CH-6962 Viganello-Lugano, Switzerland. E-mail: clinicalguidelines@esmo.org       c       l       i      n       i      c      a       l      p     r      a      c       t       i      c      e      g     u       i       d      e       l       i      n      e      s clinical practice guidelines  Annals of Oncology   23 (Supplement 7): vii139 – vii154, 2012doi:10.1093/annonc/mds233© The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.   b  y g u e  s  t   on J   ul   y1  3  ,2  0 1  6 h  t   t   p :  /   /   a nn on c  . oxf   or  d  j   o ur n a l   s  . or  g /  D o wnl   o a  d  e  d f  r  om   makes self-reporting of pain more dif  󿬁 cult, although there isno evidence of clinical reduction in pain-related suffering.When cognitive de 󿬁 cits are severe, observation of pain-relatedbehaviors and discomfort (i.e. facial expression, body movements, verbalization or vocalizations, changes ininterpersonal interactions, changes in routine activity) is analternative strategy for assessing the presence of pain (but notintensity) [14 – 17]. Different observational scales are availablein the literature [16] but none of them is validated in differentlanguages.Assessment and management of pain in children are notconsidered in this manuscript because WHO guidelines on  ‘ thepharmacological treatment of persisting pain in children withmedical illness ’  are available. recommendation Observation of pain-related behaviors and discomfort isindicated in patients with cognitive impairment to assess thepresence of pain (expert and panel consensus).Psychosocial distress has to be assessed because it is strongly associated with cancer pain [18]. In fact, psychological distressmay amplify the perception of pain-related distress andsimilarly, inadequately controlled pain may cause substantialpsychological distress. recommendation The assessment of all components of suffering such aspsychosocial distress should be considered and evaluated [II,B]. principles of pain management ã  Inform the patients about the possible onset of pain in any stage of the disease, both during and after diagnosticinterventions and as a consequence of cancer or anticancertreatments, and involve them in pain management. Patientsmust be encouraged to communicate with the physician and/or the nurse about their suffering, the ef  󿬁 cacy of therapy andside effects and to not consider analgesic opioids as a Table 1.  Causes of pain, other than cancer related pain, during natural history of cancer patientClinical Setting causesof painAcute Procedural Pain Iatrogenic Pain due to: Comorbidity-related pain Pain in cancer survivorsAdjuvant setting Diagnostic interventionLumbarpuncture ± headacheTransthoracic needlebiopsy Endoscopy ± visceraldilatationBone marrow aspiration/biopsy,Blood sampling,Central line position,Arterial line,Injections,Medication of skin ulcersMyelography and lumbarpunctureThoracocentesisSurgery,Chemotherapy, Hormonaltherapy,Target therapy Osteonecrosis of the jaw Radiation therapy Steroids can cause pain due to:skin lesions, peripheralneuropathy, mucositis aseptichead femoral necrosis, infectionsCardiovascular, Pulmonary Diabetic neuropathy,Vasomotor headache,Fibromyalgia,The comorbidity-related painmay be worsened by anticancertreatments and /or worsecancer-related painPostherpetic neuralgiaAcute thrombosis painFollow up proceduresPersisting postsurgicalpainPersisting anticancerdrug-related painPersisting radiationtherapy-related painPostherpetic neuralgiaNeoadjuvant setting As adjuvant setting plus:Diagnostic and prognostictissue biopsy As adjuvant setting without surgery-related painAs adjuvant setting As adjuvant setting Locally advancedsetting As adjuvant setting plus:Pleurodesis, tumorembolization,Suprapubic catheterization,Nephrostomy insertionAs adjuvant setting, plus:Cryosurgery,Radiothermoablation-highintensity focused ultrasound;Transarterial chemoembolizationSpinal/epidural injection;Opioid hyperalgesiaAs adjuvant setting As adjuvant setting Metastatic setting As locally advanced setting plus:Liver, lung, soft tissuediagnostic biopsies,Wound care,Movement procedural painAs neoadjuvant setting As adjuvant setting As adjuvant setting plus:Synergistic pain effectsbetween iatrogenic anddisease-related causesin long survivors clinical practice guidelines  Annals of Oncology  vii   | Ripamonti et al. Volume 23 | Supplement 7 | October 2012   b  y g u e  s  t   on J   ul   y1  3  ,2  0 1  6 h  t   t   p :  /   /   a nn on c  . oxf   or  d  j   o ur n a l   s  . or  g /  D o wnl   o a  d  e  d f  r  om   therapeutic approach for dying patients [19], thuscontributing to reduce opioidophobia. Patient involvementin pain management improves communication and has abene 󿬁 cial effect on patients ’  pain experience [20]. recommendation Patients should be informed about pain and pain managementand be encouraged to take an active role in their painmanagement [II, B]. ã  Prevent the onset of pain by means of   ‘ by the clock  ’ administration, taking into account the half-life,bioavailability and duration of action of different drugs; recommendation Analgesic for chronic pain should be prescribed on a regularbasis and not on an  ‘ as required ’  schedule [V, D]. ã  Prescribe a therapy which can be administered simply andeasily managed by the patients themselves and their families,especially when the patient is cared for at home. The oralroute appears to be the most suitable to meet thisrequirement, and, if well tolerated, it must be considered asthe preferred route of administration [21 – 26]; recommendation The oral route of administration of analgesic drugs should beadvocated as the  󿬁 rst choice [IV, C]. ã  Assess and treat breakthrough pain (BTP) de 󿬁 ned as  ‘ atransitory   󿬂 are of pain that occurs on a background of relatively well controlled baseline pain ’  [27]. Typical BTPepisodes are of moderate to severe intensity, rapid in onset(minutes) and relatively short in duration (median 30 min)[27]. recommendation Rescue dose of medications (as required or prn) other thanthe regular basal therapy must be prescribed for BTP episodes[V, D]. ã  Tailor the dosage, the type and the route of drugsadministered according to each patient ’ s needs. The type anddose of analgesic drugs are in 󿬂 uenced by the intensity of pain and have to be promptly adjusted to reach a balancebetween pain relief and side effects. The rescue doses (prn)taken by the patients are an appropriate measure of the daily titration of the regular doses. An alternative route for opioidadministration should be considered when oral intake is notpossible because of severe vomiting, bowel obstruction,severe dysphagia or severe confusion, as well as in thepresence of poor pain control which requires rapid doseescalation and/or in the presence of oral opioid-relatedadverse effects. Table 2.  Guidelines for the adequate assessment of the patient with painat any stage of the disease1. Assess and re-assess the pain ã  causes, onset, type, site, absence/presence of radiating pain, duration,intensity, relief and temporal patterns of the pain, number of breakthrough pains, pain syndrome, inferred pathophysiology, pain atrest and/or moving  ã  presence of the trigger factors and the signs and symptoms associatedwith the pain ã  presence of the relieving factors ã  use of analgesics and their ef  󿬁 cacy and tolerability  ã  require the description of the pain quality *aching, throbbing, pressure: often associated with somatic pain inskin, muscle and bone*aching, cramping, gnawing, sharp: often associated with visceral painin organs or viscera*shooting, sharp, stabbing, tingling, ringing: often associated withneuropathic pain caused by nerve damage2. Assess and re-assess the patient ã  clinical situation by means of a complete/speci 󿬁 c physical examinationand the speci 󿬁 c radiological and/or biochemical investigations ã  presence of interference of pain with the patient ’ s daily activities, work,social life, sleep patterns, appetite, sexual functioning, mood, well-being,coping  ã  impact of the pain, the disease and the therapy on the physical,psychological and social conditions ã  presence of a caregiver, the psychological status, the degree of awareness of the disease, anxiety and depression and suicidal ideation,his/her social environment, quality of life, spiritual concerns/needs,problems in communication, personality disorders ã  presence and intensity of signs, physical and/or emotional symptomsassociated with cancer pain syndromes ã  presence of comorbidities (i.e. diabetic, renal and/or hepatic failureetc.) ã  functional status ã  presence of opioidophobia or misconception related to pain treatment ã  alcohol and/or substance abuse3. Assess and re-assess your ability to inform and to communicate with thepatient and the family  ã  Take time to spend with the patient and the family to understand theirneeds Figure 1  Validated and most frequently used pain assessment tools.  Annals of Oncology clinical practice guidelines  Volume 23 | Supplement 7 | October 2012 doi:10.1093/annonc/mds233 |  vii    b  y g u e  s  t   on J   ul   y1  3  ,2  0 1  6 h  t   t   p :  /   /   a nn on c  . oxf   or  d  j   o ur n a l   s  . or  g /  D o wnl   o a  d  e  d f  r  om   pain management In 1986, the World Health Organization (WHO) proposed astrategy for cancer pain treatment based on a sequential three-step analgesic ladder from non opioids to weak opioids tostrong opioids according to PI [28]. Twenty years after thepublication of the  󿬁 rst edition [21], the WHO cancer painrelief program remains the reference point for painmanagement. According to WHO guidelines, opioid analgesicsare the mainstay of analgesic therapy and are classi 󿬁 edaccording to their ability to control pain from mild to mild – moderate to moderate – severe intensity [25, 29 – 31].Opioid analgesics may be combined with nonopioid drugssuch as paracetamol or nonsteroidal anti-in 󿬂 ammatory drugs(NSAIDs) (Algorithm 1) and with adjuvant drugs [32, 33]. recommendation The analgesic treatment should start with drugs indicated by the WHO analgesic ladder appropriate for the severity of pain[II, B].Pain should already be managed during the diagnosticevaluation. Most cancer patients can attain satisfactory relief of pain through an approach that incorporates primary antitumortreatments, systemic analgesic therapy and other noninvasivetechniques such as psychological or rehabilitative interventions. treatment of mild pain Nonopioid analgesics such as acetaminophen/paracetamol oran NSAID are indicated for the treatment of mild pain.NSAIDs are superior to placebo in controlling cancer pain insingle dose studies. Paracetamol and NSAIDS are universally accepted as part of the treatment of cancer pain at any stage of the WHO analgesic scale. There is no evidence to supportsuperior safety or ef  󿬁 cacy of one NSAID over any other [34].In a randomized clinical trial (RCT) carried out in a smallsample of cancer patients on a strong opioid regimen,paracetamol improved pain and well-being [35]. A recentsystematic review of the literature shows that the addition of anNSAID to WHO Step III opioids can improve analgesia orreduce opioid dose requirement [36].It is mandatory to periodically monitor and revise the long-term use of NSAIDs or cyclo-oxygenase-2 (COX-2) selectiveinhibitors [37] because they can induce severe toxicity such as:gastrointestinal bleeding, platelet dysfunction and renal failure.COX-2 selective inhibitors may increase the risk of thromboticcardiovascular adverse reactions [38] and do not offerprotection from renal failure. recommendations Paracetamol and/or a NSAID are effective for treating mildpain [I, A].Paracetamol and/or a NSAID are effective for treating allintensities of pain, at least in the short term and unlesscontraindicated [I, A]. treatment of mild – moderate pain In the meta-analysis of Grond et al. [39] on the analgesicef  󿬁 cacy and tolerability of weak opioids versus placebo 10/16RCTs show the superiority of opioids. However, 14/16 RCTswere single dose studies and no data are available on long-term use. Algorithm 1 clinical practice guidelines  Annals of Oncology  vii   | Ripamonti et al. Volume 23 | Supplement 7 | October 2012   b  y g u e  s  t   on J   ul   y1  3  ,2  0 1  6 h  t   t   p :  /   /   a nn on c  . oxf   or  d  j   o ur n a l   s  . or  g /  D o wnl   o a  d  e  d f  r  om 
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