Special Report
New Clinical-Practice Guidelines for the Management of Pain in Patients with Cancer
N Engl J Med 1994; 330:651-655March 3, 1994
- Article
Cancer is newly diagnosed in more than 1 million Americans annually, and 1 of 5 deaths in the United States -- about 1400 per day -- results from cancer1. Cancer is increasingly prevalent in the United States, yet unfortunately, the pain associated with it is frequently undertreated in both adults and children.
Patients with cancer often have pain from more than one source, but in up to 90 percent of patients the pain can be controlled by relatively simple means. Nevertheless, undertreatment of cancer pain is common because of clinicians' inadequate knowledge of effective assessment and management practices, negative attitudes of patients and clinicians toward the use of drugs for the relief of pain, and a variety of problems related to reimbursement for effective pain management2.
New clinical-practice guidelines (see the Appendix) have been issued by the Agency for Health Care Policy and Research, a branch of the Department of Health and Human Services, in an effort to correct the problem of inadequate treatment of pain in patients with cancer3.
The guidelines call for (1) a collaborative, interdisciplinary approach to the care of patients with cancer pain, (2) an individualized pain-control plan developed and agreed on by patients, their families, and practitioners, (3) ongoing assessment and reassessment of the patient's pain, (4) the use of both drug and nondrug therapies to prevent or control pain, and (5) explicit institutional policies on the management of cancer pain, with clear lines of responsibility for pain management and for monitoring its effectiveness. In this article we discuss the major recommendations of the guidelines.
The Assessment of Pain
The assessment of pain in patients with cancer is imperative, because failure to carry it out is recognized as an important reason for undertreatment. Patients with cancer can have transient or long-term pain, or both, related to either the disease or its treatment. They may also have unrelated preexisting painful conditions. Because of the many possible causes of pain, each time a clinician assesses a patient with cancer, evaluation of pain is required.
The initial evaluation of pain should include a detailed history taking, a physical examination with particular emphasis on the neurologic examination, a psychosocial assessment, and when appropriate, a diagnostic plan to determine the cause of new or increasing pain. In subsequent assessments the clinician should evaluate the effectiveness of the management plan and, if pain has not been relieved, determine whether the pain is related to the progression of disease, to a new cause, or to the cancer treatment.
Health care professionals should ask about pain regularly, because recent studies have shown that patients are reluctant to volunteer information about pain4. The patient's report should be the primary source of information, since it is more accurate than the observations of others. Neither behavior nor vital signs should be used in lieu of a report from the patient5. The assessment of the patient's pain and of the efficacy of the treatment plan should be ongoing, and the details of the assessment should be documented.
Some causes of pain in patients with cancer are relatively easy to diagnose and treat, such as pathologic fractures of the femur. Clinicians treating patients with cancer should also be able to recognize common cancer-pain syndromes that may cause intractable pain and that may signal the recurrence of disease. The prompt recognition of these syndromes may facilitate better treatment as well as minimize the morbidity associated with unrelieved pain. Common conditions causing pain are bone metastases, epidural metastases with spinal cord compression, plexopathies, peripheral neuropathies, and mucositis.
Pharmacologic Management
Of the many methods available to manage pain in cancer, drug therapy is the cornerstone because it entails relatively little risk, is usually inexpensive, and as a rule works quickly. An essential principle in using medications to manage pain due to cancer is to tailor the regimen to the individual patient6.
Three major classes of drugs are used alone or, more commonly, in combination to manage pain: nonsteroidal antiinflammatory analgesic drugs (NSAIDs) and acetaminophen; opioid analgesic agents; and adjuvant analgesic agents. Representative dosages of single agents within these three classes are provided in Table 1Table 1
Dosage of Opioid Analgesic Agents for Adults and Children Weighing 50 kg or More Who Have Not Previously Received Opioid Agents., Table 2Table 2
Dosage of Acetaminophen and NSAIDs for Adults and Children., and Table 3Table 3
Adjuvant Analgesic Drugs for Adults and Children Weighing 50 kg or More..When choosing drugs to manage pain or related symptoms, the simplest dosage and least invasive routes of administration should be used first. In the case of opioid analgesics, the dose should be increased if pain relief is inadequate until relief is achieved or unacceptable side effects occur. In the case of NSAIDs and adjuvant analgesic drugs, which have ceilings to their efficacy, if the upper limit of the recommended dose is reached and pain relief has not been achieved, then that particular drug should be discontinued and other drugs in the same class should be tried.
Most pain due to cancer can be managed by the oral administration of drugs; however, difficulty in swallowing, gastrointestinal dysfunction that renders drug absorption unreliable, the need to use large quantities of tablets, and many other factors may require other means of administration. A simple, well-validated, and effective method for the adjustment of therapy for pain due to cancer has been devised by the World Health Organization (WHO)7. This method produces relief of pain in approximately 90 percent of patients with cancer. The first step is the use of aspirin, acetaminophen, or another NSAID for mild-to-moderate pain. Adjuvant drugs may be used at any stage of treatment to enhance the efficacy of analgesia, to treat concurrent symptoms that exacerbate pain, or to provide independent analgesic activity for specific types of pain.
When pain persists or increases, an opioid such as codeine or hydrocodone should be added to the NSAID and adjuvant drugs (this is the second step of the WHO analgesic ladder). At this stage opioids are often administered in fixed-dose combinations with acetaminophen or aspirin, because this combination provides additive analgesia. When higher doses of opioids are necessary, fixed-dose combinations of opioid and nonopioid analgesics may be less suitable because of the risk of exceeding the maximal recommended doses of the NSAID. Patients who have moderate-to-severe pain when first seen by the clinician should be started at the second or third step of the ladder.
The treatment of persistent or moderate-to-severe pain should be based on increasing the potency or dosage of opioid agents. This is the third step of the analgesic ladder. At this stage drugs such as codeine or hydrocodone are replaced by more potent opioids, usually morphine, hydromorphone, methadone, fentanyl, or levorphanol. Medications for persistent cancer-related pain should be administered on an around-the-clock basis, with additional “as needed” doses. In a patient with continuous pain a regimen based solely on “as needed” doses makes it likely that pain will recur several times per day.
Morphine is the most commonly used opioid agent for moderate-to-severe pain because of its availability in a wide variety of doses and forms, its well-characterized pharmacokinetics and pharmacodynamics, and its relatively low cost. For use in meeting relatively constant analgesic needs, controlled-release tablets of morphine are commercially available, as are transdermal fentanyl patches. Meperidine may be useful for brief courses (e.g., a few days) to treat acute pain, but it should generally be avoided in treating patients with cancer because of its short duration of action (2.5 to 3.5 hours) and toxic effects. Its toxic metabolite, normeperidine, accumulates during continued use, particularly when renal function is impaired, and causes dysphoria, agitation, or seizures8.
Tolerance and physical dependence are common and predictable consequences of the long-term administration of opioid agents. These terms are often confused with psychological dependence (“addiction”), manifested as drug abuse. Misunderstanding of the potential for addiction when opioids are used leads to ineffective practices in requesting, prescribing, administering, and dispensing opioids for pain in patients with cancer and contributes to the problem of undertreatment.
Tolerance of opioids is defined as the need for increasing doses over time to maintain pain relief. For most patients with cancer, the first indication of tolerance is a decrease in the duration of analgesia after a given dose. Increasing dose requirements often herald the progression or recurrence of disease; for reasons that are poorly understood, patients with stable disease do not usually require rapidly increasing doses6 and, in fact, may be maintained on a stable dosage of an opioid agent for weeks or months.
Doses of opioids should be adjusted to achieve pain relief with an acceptable level of adverse effects for each patient. There is no ceiling or maximal recommended dose for full opioid agonists: very large doses of morphine (e.g., several hundred milligrams every four hours) may be needed for some patients with severe pain4. Effective pain relief can be achieved by anticipating pain -- such as that which occurs with increases in activity -- and precluding it through preemptive “breakthrough” dosing.
It is usually advisable to try, sequentially, more than one opioid before switching the method of administration or trying anesthesia, neurosurgery, or some other invasive approach to relieve persistent pain9. For example, pain in patients who have dose-limiting sedation, nausea, or mental clouding while taking oral morphine may often be managed effectively with hydromorphone or fentanyl in a dose that has an equivalent analgesic effect (an equianalgesic dose).
Oral administration is the preferred method because it is the most convenient for patients and the most cost effective. When patients cannot take medications orally, other noninvasive methods such as rectal or transdermal administration should be tried. Parenteral routes should be used only when simpler, less demanding, and less costly methods are inappropriate or ineffective. In such instances of refractory pain, allowing patients control over the amount of analgesia they receive may be helpful10. Patient-controlled analgesia most often involves the use of a programmable pump to deliver the drug intravenously, subcutaneously, or (less commonly) epidurally. Patient-administered bolus doses are useful to treat breakthrough pain and to provide a basis for more accurate titration of the rate of continuous infusion.
Although constipation and sedation are the most common side effects of opioid agents, other potential side effects include confusion, nausea and vomiting, respiratory depression, dry mouth, urinary retention, pruritus, myoclonus, altered cognitive function, dysphoria, euphoria, sleep disturbances, sexual dysfunction, physiologic dependence, tolerance, and inappropriate secretion of antidiuretic hormone. Because there is great individual variation in opioid-induced side effects, clinicians should be on the lookout for potential side effects and treat virtually inevitable ones, such as constipation, prophylactically.
Adjuvant drugs are used to enhance the analgesic efficacy of opioids, treat concurrent symptoms that exacerbate pain, and provide independent analgesic activity for specific types of pain. They may be used at all steps of the analgesic ladder. The most commonly used include corticosteroid agents, anticonvulsant agents, antidepressant agents, neuroleptic agents, and hydroxyzine.
Nonpharmacologic Management
Physical and Psychosocial Methods
Physical and psychosocial methods can be used by families and clinicians concurrently with drugs or alone. Physical methods include cutaneous stimulation such as the application of heat, cold, or electrical stimuli (as in transcutaneous electrical nerve stimulation); exercise; immobilization; and acupuncture. They may reduce the need for drugs, but they should not be used as substitutes for drugs. These methods should be introduced early to treat generalized weakness and deconditioning as well as the myofascial pain associated with periods of inactivity and immobility related to the diagnosis and treatment of cancer.
Psychosocial interventions are an important part of a multimodal approach to pain management and are commonly used in conjunction with analgesic agents. One goal of psychosocial intervention is to help the patient gain a sense of control over the pain. Cognitive techniques are designed to influence how one interprets events and bodily sensations: giving patients information about pain and its management and helping them to think differently about their pain can increase their sense of control. When psychosocial interventions are successful in relieving pain, one should never conclude that the pain was not “real.”
Invasive Treatments
With rare exceptions, noninvasive analgesic approaches should precede invasive palliative approaches, which include anesthetic techniques, neurosurgery, and other types of surgery. In a substantial minority of patients, estimated at 1 to 15 percent, the use of these invasive procedures is necessary.
Over one third of the radiation therapy used in patients with cancer is palliative, intended to relieve pain quickly and maintain control of symptoms for the rest of the patient's life11. Radiation therapy can be useful in relieving pain caused by bone metastases or plexopathies and, in general, pain in any site of symptomatic primary or metastatic disease. The literature is divided on the optimal radiation protocols to achieve tumor regression and palliation at either primary or metastatic sites. A balance is required between the killing of tumor cells and the adverse effects of radiation on normal tissues. To enhance the patient's comfort and convenience, the desired dose should be administered in the fewest possible fractions.
Otherwise intractable pain may be controlled in the short term by the application of a local anesthetic or for a longer time by the use of a neurolytic (destructive) agent for neural blockade. Approximately 50 to 80 percent of patients who receive nerve blocks for pain due to cancer benefit from the procedure12. The selection of patients and the timing of nerve division or destruction for the relief of pain are based on the exhaustion of more conservative methods, the lack of availability of clinically superior options, and the availability of a capable physician and support systems after the procedure.
Neurosurgical procedures for the relief of pain fall into three categories: ablation of nerves or nerve pathways, implantation of drug-infusion systems, and implantation of devices for electrical stimulation. The choice of a neurosurgical procedure is based on the location and type of pain (somatic, visceral, or caused by deafferentation), the general condition of the patient, the patient's life expectancy, and the nature of the expertise available.
With regard to surgical operations, pain control is usually a secondary goal when curative tumor excision is performed. In contrast, when palliative surgery is chosen because the tumor is unresectable, pain control is frequently the reason for performing the procedure. The oncologic surgeon should be familiar with the interactions of chemotherapy, radiation therapy, and surgical interventions so that iatrogenic complications (such as multiple fistulas resulting from bowel resection after radiation therapy) may be avoided or anticipated.
Continuity of Pain Management
Most patients with cancer are treated for pain in outpatient settings or at home. Patients should be taught to report changes in the nature or degree of pain or any new pain so that appropriate reassessment and changes in the treatment plan can be initiated. Patients and their families may have difficulty in understanding and remembering the details of the plan for managing pain. Therefore, patients should be given a written pain-management plan whenever possible. Discharge planners should advise patients and clinicians to communicate the details of the pain-management plan to other clinicians when the patient is being transferred from one health care facility to another -- as, for example, from an acute care facility to a hospice.
We are indebted to the panel members, reviewers, and consultants for their outstanding contributions; to research assistants Drs. Janice Fitzgerald Ulmer, Donna Mahrenholz, Elon Eisenberg, and Jane Ballantyne; to Miss Evelyn Hall for assistance in the preparation of the manuscript; and to Drs. Richard Kitz and George Battit for ongoing support and encouragement.
Supported by the Office of the Forum for Quality and Effectiveness in Health Care, Agency for Health Care Policy and Research, Department of Health and Human Services. This paper does not necessarily represent the position of the Department of Health and Human Services.
Source Information
Johns Hopkins University School of Nursing, Baltimore, MD 21205
Massachusetts General Hospital, Boston, MA 02114
M.D. Anderson Cancer Hospital, Houston, TX 77030
Address reprint requests to Dr. Carr at the Pain Center, Department of Anesthesia, Massachusetts General Hospital, Boston, MA 02114.
Appendix
Clinical-practice guidelines are “statements designed to help health care professionals and patients make better choices about treatment options for clinical conditions”13. The development of clinical-practice guidelines is one of the major responsibilities of the Agency for Health Care Policy and Research. This agency was established by Congress in late 1989 to improve the quality, appropriateness, and effectiveness of health care and to improve access to health care services. Agency guidelines, developed by multidisciplinary panels of health professionals and consumers, are based on systematic reviews of relevant scientific evidence as well as professional judgment.
The guidelines on the management of pain in cancer were released today. The entire process was overseen by an interdisciplinary panel of experts who used an integrated approach to synthesize scientific evidence and current clinical practice. Versions of the guidelines include the full text of Management of Cancer Pain: Clinical Practice Guideline (approximately 200 pages),3 two quick reference guides for clinicians (one focused on adults and the other on children),14,15 and brief consumer guides for patients and their families, published in English and Spanish versions16,17. The full guidelines include tables showing the type, strength, and consistency of the evidence for the various interventions; sample instruments for the assessment of pain in adults and children; drug-dosage tables for nonsteroidal antiinflammatory agents and opioids; sample relaxation exercises; and sites where the guidelines were tested. Free copies are available on request (telephone: 1-800-4CANCER).
- References
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