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Biomedical subjects

R K Portenoy

Publications and source records attributed to R K Portenoy.

At least 19 recordsLinked to original sources
PubMed2001

Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR).

Oral transmucosal fentanyl citrate (OTFC); Actiq) is a drug delivery formulation used for management of breakthrough cancer pain. Previous studies with open-label comparisons indicated OTFC was more effective than patients' usual opioid for breakthrough pain. The objective of this study was to compare OTFC and morphine sulfate immediate release (MSIR) for management of breakthrough pain in patients receiving a fixed scheduled opioid regimen. This double-blind, double-dummy, randomized, multiple crossover study was conducted at 19 US university- and community-based hospitals and clinics and comprised 134 adult ambulatory cancer patients. Patients were receiving a fixed scheduled opioid regimen equivalent to 60-1000 mg/day oral morphine or 50-300 microg/h transdermal fentanyl, were using a 'successful' MSIR dose (15-60 mg) as defined by entry criteria, and were experiencing 1-4 episodes of breakthrough pain per day. In open-label fashion, OTFC was titrated such that a single unit (200-1600 microg) provided adequate pain relief with acceptable side effects. Successfully titrated patients entered the double-blind phase of the study and received ten prenumbered sets of randomized capsules and oral transmucosal units. Five sets were the successful OTFC dose paired with placebo capsules, and five sets were placebo OTFC paired with capsules containing the successful MSIR dose. Patients took one set of study medication for each episode of target breakthrough pain. Pain intensity (PI), pain relief (PR) and global performance of medication (GP) scores were recorded. Pain intensity differences (PID) were calculated and 15-min PID was the primary efficacy variable. Adverse events were recorded. Sixty-nine percent of patients (93/134) found a successful dose of OTFC. OTFC yielded outcomes (PI, PID, and PR) at all time points that were significantly better than MSIR. GP also favored OTFC and more patients opted to continue with OTFC than MSIR following the study. Somnolence, nausea, constipation, and dizziness were the most common drug-associated side effects. In conclusion, OTFC was more effective than MSIR in treating breakthrough cancer pain.

Administration, Oral↗
PubMed2001

Opioid poorly-responsive cancer pain. Part 1: clinical considerations.

Pain that is poorly responsive to opioid analgesics is challenging for physicians who deal with cancer patients. Numerous factors may influence analgesic response during the course of the illness. These include changing nociception associated with disease progression, the appearance of intractable side effects, the development of tolerance, the presence of neuropathic pain, the temporal pattern, the effects produced by the production of opioid metabolites, and many others. These factors influence the delicate balance between pain relief and opioid toxicity that must be achieved in cancer patients with pain.

Disease Progression↗
PubMed2001

Opioid poorly-responsive cancer pain. Part 3. Clinical strategies to improve opioid responsiveness.

Some pain syndromes may be difficult to treat due to a poor response to opioids. This situation demands a range of alternative measures, including the use of adjuvant drugs with independent effects, such as antidepressants, sodium channel-blocking agents, steroids and anti-inflammatory drugs (NSAIDs); drugs that reduce opioid side effects; and drugs that enhance analgesia produced by opioids, such as N-methyl-D-aspartate (NMDA) antagonists, calcium channel antagonists, and clonidine. Other approaches, including opioid trials, neural blockade when necessary, and psychological interventions, also may be useful.

Analgesics, Opioid↗
PubMed2001

Long-term safety of oral transmucosal fentanyl citrate for breakthrough cancer pain.

This open-label study evaluated the long-term safety and tolerability of oral transmucosal fentanyl citrate (OTFC) in ambulatory cancer patients with breakthrough pain undergoing cancer care at 32 university- or community-based practices. Patients had participated in a previous short-term titration trial of OTFC, were experiencing at least one episode per day of breakthrough pain, and had achieved relief of their breakthrough pain with an opioid. Patients received OTFC units at a starting dosage strength determined in the short-term trial (200-1600 microg). Outcome measures included number of successfully treated breakthrough pains, global satisfaction rating (0 = poor through 4 = excellent), and side effects. In total, 41,766 units of OTFC were used to treat 38,595 episodes of breakthrough pain in 155 patients. Number of treatment days ranged from 1 to 423 (mean, 91 days). Patients averaged 2.9 breakthrough pain episodes per day. About 92% of episodes were successfully treated with OTFC and there was no trend toward decreased effectiveness over time. Most patients (61%) did not require dose escalation during treatment. Global satisfaction ratings were consistently above 3, indicating very good to excellent relief. Common adverse events associated with OTFC were somnolence (9%), constipation (8%), nausea (8%), dizziness (8%), and vomiting (5%). Six patients (4%) discontinued therapy due to an OTFC-related adverse event. There were no reports of abuse and no concerns about the safety of the drug raised by patients or families. OTFC was used safely and effectively during long-term treatment of breakthrough pain in cancer patients at home.

Administration, Oral↗
PubMed2001

Neuropathic cancer pain: the role of adjuvant analgesics.

Neuropathic pain may be defined as pain related to abnormal somatosensory processing in either the peripheral or central nervous system. This pathophysiologic label is typically applied when the painful symptom is associated with an overt injury to neural structures, is part of a recognized syndrome, or has a dysesthetic quality (usually burning, shooting, or electrical). Most neural injury does not lead to clinically important neuropathic pain, but sometimes even a small degree of tissue injury can precipitate severe pain. In the cancer population, neuropathic pain is often related to compression, direct neoplastic invasion of the peripheral nerves or spinal cord, or to a neuropathy caused by chemotherapy. To manage neuropathic pain in this population, nonopioid adjuvant drugs that are neuroactive or neuromodulatory are often needed to complement opioid therapy. The primary adjuvant analgesics are anticonvulsant and antidepressant medications, but a wide variety of other drugs are also used. To optimize analgesic therapy in patients with neuropathic pain, both opioid and adjuvant analgesics must be used effectively.

Analgesics↗
PubMed2000

A pilot survey of aberrant drug-taking attitudes and behaviors in samples of cancer and AIDS patients.

The clinical assessment of drug-taking behaviors in medically ill patients with pain is complex and may be hindered by the lack of empirically derived information about such behaviors in particularly medically ill populations. To investigate issues surrounding the assessment of these behaviors, we piloted a questionnaire based on the observations of specialists in pain management and substance abuse. This preliminary questionnaire evaluated medication use, present and past drug abuse, patients' beliefs about the risk of addiction in the context of pain treatment, and aberrant drug-taking attitudes and behaviors. This instrument was piloted in a mixed group of cancer patients (N = 52) and a group of women with HIV/AIDS (N = 111). Reports of past drug use and abuse were more frequent than present reports in both groups. Current aberrant drug-related behaviors were seldom reported, but attitude items revealed that patients would consider engaging in aberrant behaviors, or would possibly excuse them in others, if pain or symptom management were inadequate. Aberrant behaviors and attitudes were endorsed more frequently by the women with HIV/AIDS than by the cancer patients. Patients greatly overestimated the risk of addiction in pain treatment. We discuss the significance of these findings and the need for cautious interpretation given the limitations of the methodology. This early experience suggests that both cancer and HIV/AIDS patients appear to respond in a forthcoming fashion to drug-taking behavior questions and describe attitudes and behaviors that may be highly relevant to the diagnosis and understanding management of substance use among patients with medical illness.

Acquired Immunodeficiency Syndrome↗
PubMed2000

The measurement of symptoms in children with cancer.

The purpose of this study was to determine symptom prevalence, characteristics, and distress in children with cancer. The Memorial Symptom Assessment Scale (MSAS) 10-18, a 30-item patient-rated instrument adapted from a previously validated adult version, provided multidimensional information about the symptoms experienced by children with cancer. This instrument was administered to 160 children with cancer aged 10-18 (45 inpatients, 115 outpatients). To confirm the instrument's reliability and validity, additional data about symptoms were collected from both the parents and the medical charts, and retesting was performed on a subgroup of inpatients. Patients could easily complete the scale in a mean of 11 minutes. The analyses supported the reliability and validity of the MSAS 10-18 subscale scores as measures of physical, psychological, and global symptom distress, respectively. Symptom prevalence ranged from 49.7% for lack of energy to 6.3% for problems with urination. The mean (+/- SD) number of symptoms per inpatient was 12.7 +/- 4.9 (range, 4-26), significantly more than the mean 6.5 +/- 5.7 (range, 0-28) symptoms per outpatient. Patients who had recently received chemotherapy had significantly more symptoms than patients who had not received chemotherapy for more than 4 months (11.6 +/- 6.0 vs. 5. 2 +/- 5.1), and those patients with solid tumors had significantly more symptoms than patients with either leukemia, lymphoma, or central nervous system malignancies (9.9 +/- 7.0 vs. 6.8 +/- 5.5 vs. 6.8 +/- 5.0 vs. 8.0 +/- 6.1). The most common symptoms (prevalence > 35%) were lack of energy, pain, drowsiness, nausea, cough, lack of appetite, and psychological symptoms (feeling sad, feeling nervous, worrying, feeling irritable). Of the symptoms with prevalence rates > 35%, those that caused high distress in more than one-third of patients were feeling sad, pain, nausea, lack of appetite, and feeling irritable. Subscale scores demonstrated large variability in symptom distress and could identify subgroups with high distress. The prevalence, characteristics, and distress associated with physical and psychological symptoms could be quantified in older children with cancer. The data confirm a high prevalence of symptoms overall and the existence of subgroups with high distress associated with one or multiple symptoms. Symptom distress is relatively higher among inpatients, children with solid tumors, and children who are undergoing antineoplastic treatment. Systematic symptom assessment may be useful in future epidemiological studies of symptoms and in clinical chemotherapeutic trials. Symptom epidemiology may also provide a focus for future clinical trials related to symptom management in children with cancer.

Adolescent↗
PubMed2000

Clinical guidelines for intraspinal infusion: report of an expert panel. PolyAnalgesic Consensus Conference 2000.

Consensus guidelines developed by an expert panel are helpful to clinicians when there is variation in practice and lack of a firm evidence base for an intervention, such as intraspinal therapy for pain. An internet-based survey of practitioners revealed remarkable variation in practice patterns surrounding intraspinal therapy. This prompted an interdisciplinary panel with extensive clinical experience in intraspinal infusion therapy to evaluate the results of the survey, the systematic reviews of the literature pertaining to this approach, and their own clinical experience with long-term spinal infusions. The panel proposed a scheme for the selection of drugs and doses for intraspinal therapy, and suggested guidelines for administration that would increase the likelihood of a successful outcome. These expert panel guidelines were designed to provide an initial structure for clinical decision making that is based on the best available evidence and the perspectives of experienced clinicians.

Analgesics↗
PubMed2000

Current practices in intraspinal therapy--a survey of clinical trends and decision making.

Practice patterns were assessed via an internet-based survey distributed to physicians who manage implantable infusion pumps for pain management. Respondents consisted of 413 physicians who represented management of 13,342 patients, predominantly in the U.S. The survey used a standard questionnaire format plus two clinical vignettes to assess decision-making practices. The responding physicians chose morphine most often, but many other drugs were selected without clear indications. There was evidence of wide variations in clinical practice among physicians who use this modality. These findings highlight the need for practice guidelines based on research outcomes and expert experience to establish pathways for optimal management.

Analgesics↗
PubMed2000

Evidence-based review of the literature on intrathecal delivery of pain medication.

Evidence-based medicine depends on the existence of controlled clinical trials that establish the safety and efficacy of specific therapeutic techniques. Many interventions in clinical practice have achieved widespread acceptance despite little evidence to support them in the scientific literature; the critical appraisal of these interventions based on accumulating experience is a goal of medicine. To clarify the current state of knowledge concerning the use of various drugs for intraspinal infusion in pain management, an expert panel conducted a thorough review of the published literature. The exhaustive review included 5 different groups of compounds, with morphine and bupivacaine yielding the most citations in the literature. The need for additional large published controlled studies was highlighted by this review, especially for promising agents that have been shown to be safe and efficacious in recent clinical studies.

Analgesics↗
PubMed2000

Current pharmacotherapy of chronic pain.

Advances in basic and clinical research have greatly expanded the options for analgesic pharmacotherapy. There are three broad categories of analgesic medications: (1) nonopioid analgesics, which includes the nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, dipyrone, and others; (2) a diverse group of drugs known as the "adjuvant analgesics," which are defined as "drugs that have primary indications other than pain but may be analgesic in selected circumstances;" and (3) opioid analgesics. The advent of highly selective COX-2 inhibitors has generated excitement because of the possibility that these new NSAIDs will be much safer than previous COX inhibitors. However, the cost-benefit of using these relatively more expensive drugs versus other NSAIDs plus gastro-protective therapies needs to be determined. Adjuvant analgesics can be grouped into four major classes according to their use: multipurpose, neuropathic pain, musculoskeletal pain, and cancer pain. There has been a dramatic increase in the number of these drugs during the past two decades and they now play an important role in the management of chronic pain. Pain specialists are now using opioids for chronic nonmalignant pain in addition to the traditional use for acute and cancer pain. This change in practice evolved from recognition that selected patients with chronic noncancer-related pain can experience sustained analgesia and function better with these drugs, without developing an addictive disorder. The combination of opioids and other drugs, such as an N-methyl-D-aspartate-receptor antagonist, may improve the balance between analgesia and adverse effects.

Adjuvants, Pharmaceutic↗
PubMed2000

A chart review of the ordering and documentation of urine toxicology screens in a cancer center: do they influence patient management?

Urine toxicology screens (UTSs) may be useful in the diagnosis or monitoring of patients with established or suspected substance abuse. In the medically ill, including those with cancer, the test may help clinicians manage therapy with controlled prescription drugs. To describe the current use of UTSs in a cancer center, the medical records of 111 patients who underwent UTS were reviewed. These 111 patients were randomly selected from a group of 215 patients who underwent screening between January 1, 1990 and December 31, 1994 (a period during which over 80,000 admissions occurred). Fifty-six of the 111 patients had evidence of one or more illicit drugs, a prescription medication that had not been ordered, or alcohol; 50 patients had negative screens. The likelihood of a positive UTS was higher if the patient had human immunodeficiency virus (HIV) infection (100% versus 46.6%) or was undergoing treatment for chronic nonmalignant pain (100% versus 43.9%). Documentation of the UTS in the medical record was infrequent: 37.8% of the charts listed no reason for obtaining the test and the ordering physician could not be identified in 29% of the records. Eighty-nine percent of the records did not contain a subsequent mention of the result of the UTS. The result was more likely to lead to a documented outcome when it was positive rather than negative (14.3% versus 0%). These results suggest that UTSs are used infrequently in the tertiary care oncology center. The documentation surrounding the ordering and subsequent use of the test in patient management is unsystematic. The appropriate use and documentation of UTSs, like substance abuse issues in general, should be a focus of staff education and quality improvement efforts.

Adult↗