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The safety and efficacy of patient-controlled analgesia used for postoperative pain relief were evaluated. Cumulative 24-hour requirements were analyzed for possible correlation with patient characteristics. All patients who used a patient-controlled analgesia device for postoperative pain relief were reviewed from June to October 1991. The device Baxter's basal/bolus infusor with patient control module, was used to deliver fentanyl in 379 patients. The fentanyl requirement, verbal analog pain score, first passage of flatus, side effects, sedative score, and degree of satisfaction were examined. The fentanyl requirement during the first 24 hours after operation was analyzed with regard to age, body weight, and sex. The daily fentanyl consumption in the first three postoperative days was 928 +/- 352 micrograms (n = 338), 553 +/- 259 micrograms (n = 220), and 490 +/- 222 micrograms (n = 71), respectively. The requirement for fentanyl during the first 24 hours after surgery was significantly higher than for the next two days (p-value < 0.001). Fentanyl consumption correlated well with body weight, and inversely with age. No difference was found between fentanyl consumption and sex (p-value = 0.4687). The mean time to the first passage of flatus in patients with abdominal surgery was 54.6 +/- 26.4 hours. The incidence of nausea, vomiting, and dizziness was similar, about 20% of patients. Itching was noted in 7% of patients. Oversedation (class 4) was found in three patients during the first operative day, the sedative score for other patients were around class 1-3. No patient exhibited signs of respiratory depression or withdrawal syndrome.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[The efficacy of intravenous fentanyl patient-controlled analgesia for postoperative pain relief]. 134 40

This study examined analgesic efficacy and adverse effects of buprenorphine and fentanyl for the postoperative pain relief by continuous epidural infusion. Fifty patients after upper or lower abdominal surgeries were assigned to two groups and buprenorphine and fentanyl were epidurally administered postoperatively. Buprenorphine (B) group received bolus injection of B 0.1mg + saline 8 ml and continuous infusion of B 0.8 mg+saline 92 ml (2 ml.h-1). Fentanyl group received bolus injection of F 0.1 mg+saline 6 ml and continuous infusion of F 0.6 mg+saline 84 ml (2 ml.h-1). There was no significant difference between the two groups in the analgesic efficacy, which became lower from 2 to 12 hours postoperatively. However, compared with buprenorphine group, the incidence of nausea or vomiting and dizziness was significantly less in the fentanyl group (11 vs. 4 cases and 7 vs. 1 cases). These results imply that the major site of action of epidurally administered fentanyl is the spinal cord. In contrast, analgesic effect of epidural buprenorphine appears to be enhanced by the supraspinal action. We conclude that fentanyl is superior to buprenorphine for postoperative pain relief by continuous epidural infusion.
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PMID:[Comparison of buprenorphine and fentanyl for postoperative pain relief by continuous epidural infusion]. 830 22

Treatment of postoperative pain is often insufficient. It normally consists of systemic application of an analgesic drug or a regional technique of analgesia. Fentanyl-TTS may be a new approach for postoperative pain therapy. Fentanyl is incorporated into a transdermal system; after application to the skin continuous release of therapeutic doses is achieved for a period of 72 h. Serum peak levels are obtained 8-16 h after application; the serum half-life is about 16-21 h because of the dermal depot. Fentanyl-TTS was administered in several clinical studies for therapy of postoperative pain. The efficacy of this new form of application could be demonstrated. For the first 12 h the patients needed supplementary doses of analgesic drugs in the same range as the placebo groups because of the lag time of fentanyl-TTS. In the following 12 h the need for supplementary analgesics was significantly reduced. After removal of the patch, the need for analgesics was still reduced for 12 h. In 21 of 341 patients respiratory depression occurred under therapy with fentanyl-TTS; no respiratory depression was observed in the placebo groups. Thus, respiratory depression might occur in up to 9% of postoperative patients treated with fentanyl-TTS. Other adverse effects were nausea (62%), vomiting (26%), sedation (22%), urinary retention (11%), headache (5%), and dizziness (8%). Local reactions under the patch were erythema (39%) or pruritus (9%). These phenomena disappeared within a few hours. The pharmacokinetics of fentanyl-TTS have two major drawbacks: during the first 12-15 h the patients need supplementary analgesics, usually opioids.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:[Fentanyl-TTS for postoperative pain therapy. A new alternative?]. 831 89

The success of out-patients laparoscopic surgery depends on a careful selection of patients and the ability of anesthetic technique to ensure a rapid emergence from anesthesia, with a satisfactory control of postoperative pain and the absence of side effects. This study was undertaken to investigate the influence of a total intravenous anesthetic management on the recovery process after laparoscopic varicocelectomy. Fifty-three ASA 1 patients aged 12-41 yrs (mean 26.02) scheduled to undergo laparoscopic varicocelectomy as day surgery procedure were included in this study. Propofol was used as inductor agent and in variable-rate infusion (170-100 mcg/Kg/min) to maintain anesthesia supplemented with Fentanyl (FNT) before endotracheal intubation, incision surgery and if the patient manifested clinical signs of inadequate analgesia. Local anesthesia was infiltrated into the skin before incision. Tramadol 100 mg and Ketorolac 30 mg were administered before the end of surgery to delay the onset of the postoperative pain. Pain was evaluated using a self-rating visual analoque scale (VAS) ranging from 0 to 10 at 0-0.5 hrs postoperatively and every 2 hrs until discharge. At the same time nausea was clinically evaluated using a scale ranging from 0 to 3. Postoperative pain and nausea (PONV) treatment were standardized. Patients were discharged by Post-Anesthesia Discharge Scoring System (PADS). Mean operating time was 34.2 min and mean estubation time was 11.6 min. At time 0 all patients had VAS pain score < 3, on the same time 2 of patients was treated for mild PONV; mean time to first request for postoperative analgesia treatment in 89% of patients was more than 6 hrs, 5 patients required pain treatment before discharge in a mean time 216' +/- 156'. Using the PADS system, 64% of patients were discharged at 4 hrs and 89% at 6 hrs after surgery. One patient was admitted to hospital for an overnight stay for walking dizziness; another was readmitted for surgical complications. This results suggest that the proposed anesthetic management provided adequate pain control with minimun postoperative nausea and a good recovery rate. This permitted a short postoperative hospital stay without compromising in safety, efficacy, or patient satisfaction.
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PMID:[Laparoscopic surgery of varicocele. Role of total endovenous anesthesia in same-day discharge]. 1112 41

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

We investigated the efficacy and safety of gabapentin in rhinoplasty or endoscopic sinus surgery patients. Patients received either oral placebo or gabapentin 1200 mg 1 h before surgery. After standard premedication, 25 patients in each group received propofol, fentanyl, and local anesthesia at the operative site. Sedation was maintained by a continuous infusion of propofol adjusted according to the Ramsay scale. Sedation and pain scores were obtained at 5, 15, 30, 45, and 60 min during surgery and 30 min and 2, 4, 6, 8, 12, 16, 20, and 24 h after the procedure. Diclofenac 75 mg IM was administered as a rescue analgesic. Postoperative pain scores and intraoperative pain scores at 45 and 60 min were significantly lower in the gabapentin group. Fentanyl (122 +/- 40 microg versus 148 +/- 42 microg; P < 0.05) and diclofenac (33 +/- 53 mg versus 111 +/- 92 mg; P < 0.001) consumption was smaller and the time to first analgesic request (18 +/- 9 h versus 9 +/- 7 h; P < 0.001) was longer in the gabapentin group. A more frequent incidence of dizziness was found in the gabapentin (versus placebo) group (24% versus 4%, respectively). We conclude that gabapentin provided a significant analgesic benefit for intraoperative and postoperative pain relief in patients undergoing ambulatory rhinoplasty or endoscopic sinus surgery; however, dizziness may be a handicap for ambulatory use.
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PMID:The analgesic effects of gabapentin in monitored anesthesia care for ear-nose-throat surgery. 1527 9

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

BACKGROUND: Fentanyl buccal tablet (FBT; FENTORA(R), Cephalon, Inc., Frazer, PA, USA) is indicated in the US for breakthrough pain in patients with cancer who are already receiving and are tolerant to around-the-clock opioid therapy for underlying persistent cancer pain. For each individual patient, FBT should be titrated to the effective dose. OBJECTIVE: The primary objective was to characterize the pharmacokinetic parameters of FBT 400 microg administered as a single 400 microg tablet (regimen A) or as two 200 microg tablets given simultaneously (regimen B) and determine whether these are bioequivalent in healthy Japanese volunteers. Regimen C (two 200 microg tablets 30 minutes apart) was also compared as a secondary objective. METHODS: Healthy Japanese adults received regimens A, B, and C in a crossover fashion. Naltrexone was given to minimize the opioid effects of fentanyl. Serum fentanyl concentrations were determined in venous blood collected through 36 hours post dose. Regimens were declared bioequivalent with respect to bioavailability (as reflected by AUC(0-infinity), AUC(0-last), and C(max)) if the 90% confidence interval (CI) of the regimens' ratio fell within 0.80-1.25 (80%-125%). RESULTS: Twenty-nine volunteers (13 men, 16 women) were enrolled; 24 completed the study. Regimens A and B had bioequivalent systemic exposure parameters (B/A [90% CI]: AUC(0-infinity)108.4 [103.4, 113.7], AUC(0-last) 106.1 [100.7, 111.7], and C(max) 92.3 [83.2, 102.4]). Regimen C was bioequivalent to both A and B for AUCs, but only to B for C(max). Median time to C(max) was 45 minutes for regimen A and 60 minutes for regimens B and C. The most frequent AEs were dizziness, application-site erythema, headache, somnolence, nausea, and vomiting. All AEs were mild or moderate. CONCLUSIONS: Bioavailability of fentanyl after FBT 400 microg administered as a single tablet was bioequivalent to that after 2 simultaneously administered 200 microg tablets in healthy Japanese volunteers. AEs were mild or moderate.
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PMID:Relative Bioavailability of Fentanyl Following Various Dosing Regimens of Fentanyl Buccal Tablet in Healthy Japanese Volunteers. 1991 9

Fentanyl buccal tablet (FBT) is indicated for the treatment of breakthrough pain in patients who are already receiving, and who are tolerant to, opioid therapy for underlying, persistent cancer pain. Breakthrough pain may be severe or excruciating, and some patients may require high doses of rapid-onset opioids to obtain adequate analgesia. The objective of this study was to assess the dose proportionality of FBT over a range of 600-1300 microg in healthy subjects. This was a randomized, open-label, four-period, crossover, single-centre study of FBT (Fentora) conducted in healthy adult subjects who were not tolerant to opioids. The study included 120 men and women aged 18-45 years with a body mass index of 20-30 kg/m2 who had no clinically significant findings on medical and psychiatric histories, physical examination, ECG or standard clinical laboratory tests, and who had a negative urine screen for drugs and alcohol. Eligible subjects were randomized to one of four dose sequences: ABDC, BCAD, CDBA and DACB, where A, B, C and D were FBT doses from lowest to highest (600, 1000, 1200 and 1300 microg). Each dose of FBT was separated by a minimum of 7 days. Naltrexone 50 mg was administered to block the opioid receptor-mediated effects of fentanyl. Plasma fentanyl concentration was measured through 72 hours after placement of FBT. The main outcome measures, maximum plasma fentanyl concentration (C(max)) and area under the plasma drug concentration versus time curve from time zero to infinity (AUC(infinity)), were analysed to determine dose proportionality. Other pharmacokinetic parameters were also evaluated. Dose proportionality was concluded if the two-sided 90% confidence intervals (CIs) for the slopes of the C(max) versus dose and AUC(infinity) versus dose curves were completely contained within the range of 0.711-1.289. The safety and tolerability of FBT were assessed throughout the study. The slope for C(max) versus dose was 0.8627 (90% CI 0.7730, 0.9525), and the slope for AUC(infinity) versus dose was 0.9330 (90% CI 0.8738, 0.9922). Given that the CIs for C(max) and AUC(infinity) were within the predefined range of 0.711-1.289, dose proportionality was concluded over the 600-1300 microg range. The mean dose-normalized plasma fentanyl concentration reached 80% of C(max) within 25 minutes; plasma fentanyl concentration was maintained at this level for 3 hours after dose. No unexpected safety or tolerability concerns were noted in the naltrexone-blocked healthy subjects. Seventy-four subjects (68%) experienced adverse events (AEs); all were mild (56 [51%]) or moderate (18 [17%]). The most common AEs were nausea, dizziness and headache. No serious AEs were reported. The dose proportionality of FBT from 600-1300 microg was shown in healthy subjects. Based on the data, when FBT is titrated up to 1300 microg, a predictable and linear increase in systemic exposure can be expected. Currently, FBT is approved up to 800 microg. This study provides pharmacokinetic data to support a potential, expanded therapeutic dose range of FBT.
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PMID:Dose proportionality of fentanyl buccal tablet in doses ranging from 600 to 1300 microg in healthy adult subjects: a randomized, open-label, four-period, crossover, single-centre study. 2044 Dec 45


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