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Intrathecal drug delivery (IDD) is a proven and effective treatment alternative in carefully selected patients with chronic pain that cannot be controlled by a well-tailored drug regime and/or spinal cord stimulation (SCS), and may be specifically trialed in patients who fail to respond to SCS. While the lack of randomized controlled trials is often perceived as a limitation of IDD, many studies attest to the efficacy of this therapy, and a number are large-scale and with follow-up periods of up to five years. Good to excellent pain relief is achieved in many patients who have failed more conservative therapies, and there is often a reduced need for analgesia. The advent of patient-controlled analgesia allows flexibility of dosing according to the patient's needs. Consequently, quality of life improves in many patients and the majority express satisfaction with treatment. Some patients are able to return to work. The benefits of IDD (including a potent analgesic response with a more stable therapeutic drug level, decreased latency, increased duration of action, and decreased pharmacological complications) mean that side effects such as nausea, vomiting, sedation, and constipation are reduced. In addition, IDD demonstrates long-term cost-effectiveness when compared to conventional pain therapies, addressing a concern that affects many physicians in clinical practice today.
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PMID:Drug delivery systems. 1730 10

Simultaneous use of opioids with a different pharmacological profile during anesthesia may lead to unexpected prolongation of effects. In addition, long-term use of transdermal buprenorphine may result in a reduced sensitivity to opioid anesthesia. In a prospective study, possible overlap of opioid effects and vigilance was determined in a group of patients (n = 22) using a buprenorphine patch for at least two months for treatment of chronic pain, and undergoing fentanyl-based fast-track enflurane anesthesia for open-heart surgery. The patients using buprenorphine were compared with a control group (n = 21) undergoing similar open-heart procedures with no opioid other than fentanyl on board. Aside from time to extubation, total dose of fentanyl, postoperative blood gases, and vigilance assessment score were used to determine possible overlap of opioid effects and/or development of opioid tolerance in the buprenorphine group compared to the control group. Both groups had similar operation and anesthesia times and comparable doses of fentanyl (0.69 mg +/- 0.23 vs. 0.67 mg +/- 0.16 SD). There was no significant difference in postoperative arterial blood gases (PaO2 136 +/- 48 torr vs. 128 +/- 35 torr SD; PCO2 43.3 +/- 3.3 torr vs. 41.9 +/- 1.2 torr SD), time until extubation (27 +/- 22 min vs. 33 +/- 24 min), and postanesthetic vigilance and recovery score (6.8 +/- 1.0 vs. 7.5 +/- 0.8, arbitrary units) between the two groups. Because of adaptive mechanisms and the development of tolerance in patients using buprenorphine, respiratory depression or sedation does not project into the postoperative period. The significant (p < 0.05) lower incidence of nausea and emesis in patients with transdermal buprenorphine owes to the development of tolerance to these opioid-related side effects.
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PMID:No potentiation of fentanyl by use of transdermal buprenorphine in patients undergoing fast-track anesthesia for open-heart surgery. 1731 20

The ability of the somatosensory system to detect noxious and potentially tissue-damaging stimuli is an important protective mechanism, that involves multiple interacting peripheral and central mechanisms. The postoperative pain is related with surgical procedure irrevocable. The effective relief of pain is of paramount importance to anyone treating patients undergoing surgery. This should be achieved for humanitarian reasons, but there is now evidence that pain relief has significant physiological benefit. Not only does effective pain relief mean a smoother postoperative course with earlier discharge from hospital, but it may also reduce the onset of chronic pain syndromes. Pain causes an increase in the sympathetic response of the body with subsequent rises in heart rate, cardiac work and oxygen consumption. Prolonged pain can reduce physical activity and lead to venous stasis and an increased risk of deep vein thrombosis and consequent pulmonary embolism. In addition, there can be widespread effects on gut and urinary tract motility which may lead, in turn, to postoperative ileus, nausea, vomiting and urinary retention. These problems are unpleasant for the patient and may prolong hospital stay. Choice of technique will also be influenced by the degree of training and expertise of the staff. The choice of pain-relieving techniques may be influenced by the site of surgery.
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PMID:[Postoperative pain therapy in otolaryngological department]. 1734 25

After a cleardiagnosis has been made, many acute as well as chronic pain symptoms can be treated by the family physician on an outpatient basis. For the step therapy of chronic pain, particular attention must be given to the side effects. In some cases, side effects necessitate the use of comedication, such as for nausea, constipation or depression. Particularly complex pain treatments should still be treated by the specialist.
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PMID:[Basic pain management care by the family physician]. 1770 88

Cannabis sativa L. is possibly one of the oldest plants cultivated by man, but has remained a source of controversy throughout its history. Whether pariah or panacea, this most versatile botanical has provided a mirror to medicine and has pointed the way in the last two decades toward a host of medical challenges from analgesia to weight loss through the discovery of its myriad biochemical attributes and the endocannabinoid system wherein many of its components operate. This study surveys the history of cannabis, its genetics and preparations. A review of cannabis usage in Ancient Egypt will serve as an archetype, while examining first mentions from various Old World cultures and their pertinence for contemporary scientific investigation. Cannabis historians of the past have provided promising clues to potential treatments for a wide array of currently puzzling medical syndromes including chronic pain, spasticity, cancer, seizure disorders, nausea, anorexia, and infectious disease that remain challenges for 21st century medicine. Information gleaned from the history of cannabis administration in its various forms may provide useful points of departure for research into novel delivery techniques and standardization of cannabis-based medicines that will allow their prescription for treatment of these intractable medical conditions.
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PMID:History of cannabis and its preparations in saga, science, and sobriquet. 1771 11

Acupuncture (AP) is effective for the treatment of postoperative and chemotherapy-induced nausea/vomiting and for postoperative dental pain. Several recent randomized trials have provided strong evidence for beneficial AP effects on chronic low-back pain and pain from knee osteoarthritis. For many other chronic pain conditions, including headaches, neck pain, and fibromyalgia, the evidence supporting AP's efficacy is less convincing. AP's effects on experimental pain appear to be mediated by analgesic brain mechanisms through the release of neurohumoral factors, some of which can be inhibited by the opioid antagonist naloxone. In contrast to placebo analgesia, AP-related pain relief takes considerable time to develop and to resolve. Thus, some of the long-term effects of AP analgesia cannot be explained by placebo mechanisms. Furthermore, it appears that some forms of AP are more effective for providing analgesia than others. Particularly, electro-AP seems best to activate powerful opioid and non-opioid analgesic mechanisms.
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PMID:Mechanisms of acupuncture analgesia: effective therapy for musculoskeletal pain? 1817 1

Studies of populations with chronic cancer pain have shown a high prevalence of breakthrough pain (BTP), defined as transitory, severe flares of pain that occur on a background of otherwise controlled, persistent pain. High BTP prevalence rates have also been reported in patients with chronic noncancer pain, although data in these patient populations are more limited. The incidence of BTP appears to be associated with progression of chronic disease, with more than 80% of patients reporting BTP with far-advanced, end-stage cancer and noncancer terminal conditions (1). The most widely accepted therapeutic approach for the management of BTP involves use of short-acting opioids taken as needed in addition to the around-the-clock opioid regimen being used for the continuous component of the persistent pain syndrome. For some patients, an optimal treatment outcome for BTP may be unattainable because of a mismatch between the time course of the BTP episode and the onset of analgesia of short-acting opioids. Breakthrough pain typically reaches peak intensity within a few minutes, whereas the onset of analgesia with traditional, orally administered short-acting opioids is between 30 and 60 minutes (2-7). Consequently, treatment outcomes for BTP are likely to be improved with agents that have a more rapid onset of analgesia. Fentanyl buccal tablet (FBT) is a new formulation of fentanyl indicated for the management of BTP in patients with cancer who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain. The FBT formulation uses OraVescent (Cephalon, Inc., Frazer, PA, USA) drug delivery technology to provide rapid absorption of fentanyl through the buccal mucosa. In pharmacokinetic studies in healthy volunteers, FBT demonstrated high, early systemic absorption. In addition, FBT delivered a larger proportion of the fentanyl dose transmucosally and produced a greater early systemic exposure than oral transmucosal fentanyl citrate (OTFC), which is also indicated for the management of BTP in opioid-tolerant cancer patients. A number of short-term studies have evaluated the efficacy, safety and tolerability of FBT in the management of BTP in opioid-tolerant patients with chronic pain. All these studies included an open-label dose-titration phase prior to randomized, placebo-controlled, double-blind treatment. Pain Intensity of a BTP episode was measured using an 11-point scale (0 = no pain, 10 = worst pain), and the primary outcome measure was the Summed Pain Intensity Difference (SPID) at a specified time point. Secondary efficacy measures included Pain Relief, Pain Intensity Differences, and the proportion of BTP episodes demonstrating >or=33% and >or=50% improvement in Pain Intensity scores at each time point postdose, and the proportion of BTP episodes requiring supplemental medication. In a pivotal study of opioid-tolerant patients with cancer-related chronic pain and BTP, the primary outcome measure, SPID at 30 minutes (SPID(30)), significantly favored FBT compared with placebo (mean +/- SE: 3.0 +/- 0.12 vs. 1.8 +/- 0.18, p<0.0001). Better efficacy was also observed with FBT compared with placebo for pain relief, Pain Intensity Differences, and the proportion of episodes showing >or=33% and >or=50% improvement in Pain Intensity Scores. Treatment with FBT was generally well tolerated. Most adverse events were mild to moderate in severity and typical of those associated with opioid use (e.g., nausea, dizziness) (8). Similar results have been observed in studies of opioid-tolerant patients with BTP in association with noncancer-related chronic pain. In a study of patients with chronic low back pain, the primary outcome measure, SPID(60), significantly favored FBT over placebo (mean +/- SE: 8.3 +/- 0.66 vs. 3.6 +/- 0.57, p <0.0001). All secondary efficacy measures were similarly improved, with Pain Intensity Differences and Pain Relief scores showing significant differences versus placebo as early as 10 and 15 minutes, respectively. As in the study of cancer patients, treatment with FBT was well tolerated (9). Across all studies, there was no simple linear relationship between the effective dose of FBT and the dose of the around-the-clock opioid regimen or the previous supplemental opioid, indicating that doses of FBT should be individually titrated to effectiveness rather than calculated as a percentage of existing opioid regimens. This monograph summarizes current data on the clinical pharmacology, efficacy, safety and tolerability of FBT relating to the management of opioid-tolerant patients with BTP in association with chronic pain.
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PMID:Fentanyl buccal tablet. 1830 3

Up to 70% of cancer patients in the terminal phase of their disease complain of moderate or severe pain. Pain therapy in these patients follows the analgesic ladder of the WHO. Many cancer patients will need a strong opioid to get sufficient pain relief. Fentanyl-TTS (transdermal therapeutic system) may be a new alternative for chronic pain therapy in cancer patients. Analgesic rates of fentanyl are released from the patch over a period of 72 h. After application, peak serum concentrations of fentanyl are measured after 8-16 h. Serum half-life time is prolonged (16-21 h) because of the intradermal depot of fentanyl. The efficacy of Fentanyl-TTS in pain therapy for cancer patients was demonstrated in clinical studies, which showed a good analgesic effect over a long period of time. Like the chronic therapy of cancer pain with conventional opioid routes, dose escalation was necessary in most patients. In most studies the application of another opioid in a second route of application was necessary as a rescue medication. During therapy of cancer pain with Fentanyl-TTS, 3 of 246 patients developed a bradypnea (respiratory rate <10/min). In contrast, respiratory depression in chronic cancer pain was never reported when the opioid was administered orally or regionally and when technical faults were excluded. The side effects during therapy with Fentanyl-TTS were those accompanying chronic opioid therapy (constipation, vomiting, nausea). The patch was well tolerated by the skin. Local side effects were minor (erythema, pruritus, pustules) and disappeared within a few hours after removal of the patch. The transdermal application of a strong opioid may be an alternative, especially for patients with cancer of the head and neck or in the gastrointestinal tract. Because of the pharmacokinetic laziness of the system the use of Fentanyl-TTS should be limited to patients with stable tumor pain. In these patients Fentanyl-TTS might be valuabe on step III of the analgesic ladder of the WHO or as an alternative to invasive methods when it is impossible to administer oral opioids.
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PMID:[Transdermal fentanyl for the treatment of cancer pain.]. 1841 15

Analgesic pharmacotherapy represents one of the major approaches to the treatment of cancer pain, since it is used in almost every patient. A thorough evaluation of the physical and mental status of the patient and of the pain is as necessary as a sound understanding of the pharmacokinetic and pharmacodynamic characteristics of the analgesics selected. The World Health Organization (WHO) has issued a basic 3 stage progression for the treatment of cancer pain, the "WHO Analgesic Ladder". Assignment to the stages depends mainly on the intensity of the pain rather than on its specific aetiology. Mild to moderate pain is treated with non-opioid drugs; moderate to severe pain, with a combination of a "weak" opioid and a non-opioid; and "strong" opioids should be used in combination with a non-opioid in the case of severe pain. Adjuvant drugs can be added if specifically indicated. Nonopioid analgesics include non-acidic compounds, e. g. paracetamol and metamizole, and acidic non-opioids, e. g. acetylsalicylic acid and newer non-steroidal anti-inflammatory drugs (NSAID). In contrast to most of the opioid analgesics, they have a ceiling effect for analgesia. Addiction and tolerance are extremely rare concerns. Opioids can be subgrouped into "weak" (e. g., codeine, dextropropoxyphene) and "strong" opioids (e. g., morphine) and also into drugs interacting with different opioid-receptor subtypes. Whereas pure agonists (e. g., morphine) produce increasingly intense analgesia with increasing dose, partial agonists and agonist-antagonists have a ceiling effect for analgesia and therefore have only a minor role in the treatment of chronic pain in cancer patients. Adverse effects occur in most patients in a dose-dependent manner. The most common of these is constipation; nausea, vomiting and sedation occur mostly at the start and can usually be treated effectively. The appropriate dosage, route of administration and dosage scheme of analgesics needs to be worked out for each individual patient in intensive work with the patient and a close follow-up, for years if necessary. Some analgesics may not be available in some countries, or only in specific preparations.
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PMID:[Drug therapy for tumor pain I. Properties of non-opioids and opioids.]. 1841 58

Chronic pain requires chronic treatment. Dihydrocodeine retard (DHC) complies with the requirements for treatment of chronic pain: its sustained release formula provides pain relief for up to 12 h. Thus, taking two tablets of this preparation daily is sufficient to ensure continuous pain relief. Patients and methods The 309 physicians participating in the study treated a total of 1502 patients and provided more than 5000 reports containing data on pain relief and side effects. Treatment was performed according to the WHO principles for the analgesic treatment of cancer pain patients, i.e., doctors and patients were taught that two tablets are taken per day, one in the morning and one in the evening, irrespective of whether pain was present or not. Most of the data were derived from the first 4 weeks of treatment. Patients were selected at random. All had chronic pain, but the diagnosis was not a selection criterion. The patients had had prior treatment with various analgesic regimens, and in most cases drugs were administered at irregular intervals, i.e., on demand. About half of the patients (54%) suffered from pain related to the musculoskeletal system such as back pain, joint pain, polyarthritis. Twenty-four percent had cancer pain and 22% had pain caused by other sources, mostly neuropathic pain, including cases of severe postherpetic neuralgia. Most of the patients were older than 50 years; the average age in the patient population was 62 years. There were 816 women and 686 men. Patients assessment of analgesic treatment was performed before starting therapy with DHC (thus conferring to prior therapy) and after 1 and 2 weeks of treatment with the new drug. While only about 10% of the patients found their prior pain treatment excellent or good, nearly 80% rated the treatment with DHC as excellent or good and only 2% as bad.Severity of pain was assessed by the patients on a four-step verbal rating scale ranging from "no or little pain" to "extremely strong pain". At the time of admission to this post-marketing surveillance 51.5% of the patients suffered from very strong pain and 41% reported strong pain. Five percent had extremely strong pain and only 2.1% reported no or little pain. After 2 weeks of treatment with DHC, 54.5% had little or no pain, 29% suffered from strong pain, 7% from very strong, and 0.4% from extremely strong pain.Sleeping problems are known to be reported by patients with chronic pain. They often cannot sleep continuously for more than a few hours. Thus, the effect of DHC on sleep was evaluated. Before starting the new treatment only 8% of the patients were having uninterrupted sleep for 6 h or more, and more than 50% of the patients slept less than 3 h. During treatment with DHC 48% of the patients had more than 6 h of uninterrupted sleep and about 82% slept continuously for more than 3 h per night. Side effects About 20% of patients reported nausea at baseline (during previous treatment); vomiting was reported in 7.6%. These percentages did not change during the first week of treatment with sustained-release DHC and even decreased slowly during the next 3 weeks. The frequency of constipation increased from 14% at baseline to about 29.5% at the end of the second week of treatment with DHC with no change during the next four weeks. A total of 312 side effects were mentioned in 5308 reports delivered by the 1502 patients during the treatment with DHC (including multiple reports). The most frequent side effects were gastrointestinal (n=106), followed by symptoms related to the central nervous system such as dizziness, sedation, etc. (n=50), and non-specific symptoms such as indisposition (n=29). Other specific symptoms were rare and distributed over many different organ systems. Insummary, the findings of this post marketing surveillance study suggest that sustained-release dihydrocodeine is an effective and safe analgesic drug for the treatment of chronic pain of various causes.
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PMID:[Pain treatment with dihydrocodeine slow release. Results of a post marketing surveillance study.]. 1841 87


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