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 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

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.
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PMID:Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). 1124 84

In this prospective, randomized, double-blind, placebo-controlled study, the use of continuous subhypnotic propofol infusion as an antiemetic in fentanyl intravenous patient-controlled analgesia (i.v. PCA) was investigated during the first 24 h after surgery. One hundred female patients, ASA I-II, aged 20-71 yr, undergoing major gynaecological or orthopaedic surgery, were included. Either propofol 10 mg or placebo (1 ml of Intralipid) was given and one of the following five regimens was maintained for 24 h: propofol 5, 10, 15 or 20 microg kg(-1) min(-1) or Intralipid 1 ml h(-1) as a placebo. Fentanyl i.v. PCA was started in the postanaesthesia care unit for postoperative analgesia. Significantly more of the patients given propofol 15 and 20 microg kg(-1) min(-1) experienced no nausea or vomiting compared with those given placebo (65% and 70% versus 25%; P<0.05). Patients given propofol 20 microg kg(-1) min(-1) reported more sedation than those in the other groups 4 h after surgery (P<0.05).
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PMID:Prevention of postoperative nausea and vomiting by continuous infusion of subhypnotic propofol in female patients receiving intravenous patient-controlled analgesia. 1173 27

Incorrect treatment of chronic pain is common cause of patient's discontentment and suffering. The problem is mostly occurring because of inappropriate pain treatment. The WHO guidelines recommends declining of prejudices and using of strong opioids in therapy after the unsatisfactory treatment with weaker analgesics. Strong opioid analgesic fentanyl in transdermal system (Durogesic TTS) is introduced. In rheumatology, it is recommended for all conditions characterised by chronic pain with intensity 4 and more on the VAS scale (0-10). It is mostly used in rheumatoid arthritis, osteoarthritis, low back pain and neuropathic pain. Durogesic TTS provides continuous pain relief for 72 hours, with constant serum concentrations. It has to be gradually titrated and starting dose is 25 micrograms/h. Possible adverse events (nausea, vomiting, constipation, sedation, itching) are short termed, transitory and easily managed. Results of some clinical trials and personal experiences that are proving its efficacy and safety are presented.
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PMID:[Treatment of chronic pain--use of transdermal fentanyl (Durogesic TTS)]. 1247 59

Fentanyl is commonly used for spinal analgesia during labour but it is associated with a high incidence of pruritus. This randomised, double-blind, placebo-controlled study was performed to evaluate the effect of prophylactic ondansetron on the incidence and severity of pruritus among parturients receiving intrathecal fentanyl as part of combined spinal-epidural analgesia. Seventy-three women were randomised to receive either saline placebo (group P, n = 25), ondansetron 4 mg (group O4, n = 23) or ondansetron 8 mg (group O8, n = 25) intravenously before intrathecal fentanyl 25 micrograms and bupivacaine 2 mg. The incidence and severity of pruritus were measured using a verbal rating and a visual analogue scale, and by the requirement for rescue anti-pruritic medication (naloxone). The overall incidence of pruritus was 95% (group P 100%, group O4 95%, group O8 90%). There were no significant differences between groups for severity of pruritus or requirement for treatment (naloxone given to 45%, 28% and 35% of groups P, O4 and O8 respectively). Secondary outcomes such as the incidence of headache, pain and nausea were not significantly different between groups. We conclude that prophylactic ondansetron 4 or 8 mg intravenously was ineffective in reducing the incidence or severity of intrathecal fentanyl-induced pruritus during labour.
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PMID:Intrathecal fentanyl-induced pruritus during labour: the effect of prophylactic ondansetron. 1532 38

In summary, the advances of the last half of the 20th century in general anesthesia delivery by oral and maxillofacial surgeons are the following: 1. Oral and maxillofacial surgeons in training are exposed to significantly more hospital general anesthesia training and in addition spent much of their residency training performing general anesthesia on outpatient dental patients undergoing dentoalveolar surgery. Training programs increased from one year to three years, then to four years and finally, many six-year programs were developed that award the MD degree during or following completion of the residency program. 2. Self-evaluation programs were initiated in the late 1960s and evolved into mandatory in-office evaluation by peer practitioners and later into state-regulated evaluation. These programs began in Southern California and spread to encompass the entire United States. 3. Intravenous ultra-fast acting barbiturate office anesthesia became very refined and several combination drug "balanced" techniques developed. 4. Benzodiazepines, first diazepam then midazolam were introduced and gained wide acceptance by the dental profession. 5. New synthetic narcotic agents were introduced, which give the oral surgeon another pain control and anesthesia supplement. The new agents were short acting but very effective for the period necessary to complete most office surgical procedures. Fentanyl is the prototype for these agents. 6. Monitoring devices were incorporated into practice, and currently all oral surgeons use the pulse oximeter, the electrocardiograph, and blood pressure monitoring devices. All of these monitors are required by the California general anesthesia regulations. 7. Propofol, an entirely new type of intravenous agent, was introduced and is used by more than half of oral surgeons reporting in a survey of drugs used in 2003. Propofol may be used by incremental injection or by continuous infusion incorporating an automatic infusion pump. 8. Sevoflurane, a potent inhalation anesthetic that has many properties of an ideal agent - rapid onset, potent, easily delivered by calibrated vaporizers, rapid emergence, infrequent postoperative nausea, and favorable acceptance by almost all patients about to undergo general anesthesia - is gaining acceptance and use by oral and maxillofacial surgeons.
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PMID:Fifty years of general anesthesia in California oral and maxillofacial surgery. 1562 7

BACKGROUND: Potentiating the effect of intrathecal local anesthetics by addition of intrathecal opiods for intra-abdominal surgeries is known. In this study by addition of fentanyl we tried to minimize the dose of bupivacaine, thereby reducing the side effects caused by higher doses of intrathecal bupivacaine in cesarean section. METHODS: Study was performed on 120 cesarean section parturients divided into six groups, identified as B8, B10 and B 12.5 8.10 and 12.5 mg of bupivacaine mg and FB8, FB10 and FB 12.5 received a combination of 12.5 mug intrathecal fentanyl respectively. The parameters taken into consideration were visceral pain, hemodynamic stability, intraoperative sedation, intraoperative and postoperative shivering, and postoperative pain. RESULTS: Onset of sensory block to T6 occurred faster with increasing bupivacaine doses in bupivacaine only groups and bupivacaine -fentanyl combination groups. Alone lower concentrations of bupivacaine could not complete removed the visceral pain. Blood pressure declined with the increasing concentration of Bupivacaine and Fentanyl. Incidence of nausea and shivering reduces significantly whereas, the postoperative pain relief and hemodynamics increased by adding fentanyl. Pruritis, maternal respiratory depression and changes in Apgar score of babies do not occur with fentanyl. CONCLUSION: Spinal anesthesia among the neuraxial blocks in obstetric patients needs strict dose calculations because minimal dose changes, complications and side effects arise, providing impetus for this study. Here the synergistic, potentiating effect of fentanyl (an opiod) on bupivacaine (a local anesthetic) in spinal anesthesia for cesarian section is presented, fentanyl is able to reduce the dose of bupivacaine and therefore its harmful effects.
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PMID:Synergistic effect of intrathecal fentanyl and bupivacaine in spinal anesthesia for cesarean section. 1590 98

Fentanyl buccal tablets (FBT) are designed to manage the breakthrough pain associated with chronic pain with an enhanced rate and extent of fentanyl absorption through the buccal mucosa. The formulation incorporates an effervescent reaction to produce large shifts in pH that enhance absorption. Results from studies of safety and tolerability have shown FBT to be effective and well tolerated in opioid-tolerant chronic pain patients. Adverse events were similar to those seen with other opioids and included nausea and somnolence. Adverse events were common but mild or moderate in most cases and did not cause a high drop-out rate. In addition to the treatment of breakthrough pain, FBT could be clinically efficacious for the treatment of brief, anticipated painful events. The abuse liability of FBT is unknown and caution should be used in prescribing FBT to patients with histories of substance abuse.
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PMID:Fentanyl buccal tablets. 1704 Feb 4

Fentanyl buccal tablet (FBT) is a new opioid formulation providing rapid-onset analgesia for the treatment of breakthrough pain (BTP). This study evaluated FBT for BTP in opioid-tolerant patients with chronic cancer pain. The study had a randomized, double-blind, placebo-controlled design and was conducted at 30 outpatient treatment centers in the United States. Following open-label titration, patients were randomly assigned to 1 of 18 double-blind dose sequences (7 FBT tablets, 3 placebo) to treat 10 BTP episodes. Pain intensity was measured on an 11-point scale (0 = no pain; 10 = worst pain). The primary efficacy measure was the sum of pain intensity differences (PIDs) for the first 60 minutes (SPID60); secondary efficacy measures included PIDs and pain relief (PR) measured from 5 minutes through 2 hours. Adverse events (AEs) were recorded. Of 129 patients enrolled, 87 entered the double-blind phase. SPID60 significantly favored FBT versus placebo (mean +/- SE, 9.7 +/- 0.63 vs 4.9 +/- 0.50; P < 0.0001). Secondary measures also favored FBT: PIDs and PR showed significant differences versus placebo at 10 minutes (0.9 vs 0.5; 0.815 vs 0.606, respectively, P < 0.0001) and all subsequent time points (P < 0.0001). AEs were typical of opioids (eg, nausea, dizziness, fatigue). In conclusion, in this study of opioid-tolerant patients with chronic cancer pain and BTP, FBT was efficacious, well tolerated, demonstrated rapid onset of analgesia (within 10 minutes), and had a sustained effect.
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PMID:Fentanyl buccal tablet for relief of breakthrough pain in opioid-tolerant patients with cancer-related chronic pain. 1770 23

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


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