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Objective:To observe the effect of transdermal fentanyl combined with gabapentin for the treatment of malignant neu-ropathic pain (MNP). Methods:A total of 60 patients with MNP were randomly divided into two groups. A total of 30 cases in the con-trol group received transdermal fentanyl according to the dosages of opioid medicine that patients used. Such dosages were gradually in-creased until the pain relief visual analogue scale (VAS) fell below 3 or until the times of breakthrough pain became less than 3. For the combined group, gabapentin was co-administered with transdermal fentanyl, similar to the control group. Initially, 100 mg of gabapen-tin was administered thrice a day. This dosage was gradually increased until pain relief. However, gabapentin dosages were kept below 2,400 mg a day. VAS, quality of life (QOL), degree of pain relief, dosages of fentanyl and morphine, and side effects were evaluated be-fore treatment and at one, two, three, and four weeks after the treatment. Results:Both groups exhibited lower VAS after treatment (P<0.05), but the difference was observed to be more significant in the combined group than that in the control group (P<0.05). Both groups exhibited improved QOL (P<0.05), which was observed to be more significant in the combined group than in the control group (P<0.05). The effective rate was 96.7%in the combined group and 83.3%in the control group. The dosage of opioid medicine and the side effects in the combined group were less than those in the control group. Conclusion:Transdermal fentanyl combined with gabapen-tin is effective for the treatment of malignant neuropathic pain.
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Objective To investigate the clinical efficiency,safety,adverse reactions and healthrelated life quality of transdermal fentanyl patches for pain management in terminal cancer patients with hepatic and renal dysfunction and ascites.Methods 98 terminal cancer patients with moderate to serve pain combined with abnormal hepatic and renal dysfunction were randomly divided into two groups.Group Ⅰ (n=56)received transdermal fentany patches.Group Ⅱ,the control group (n=42),received morphine controlledrelease tablets.Terms of pain intensity,function of renal and liver,adverse reactions and heath-related quality of life were assessed before and after treatment.Results Patients were satisfied with their pain management in both groups,and no significant difference in pain release was observed between the groups (x2 =0.01,0.07,0.01,0.04,P ＞ 0.05).The incidences of constipation and dysuresia were significantly less in the group Ⅰ compared with that of the group Ⅱ (x2 =7.32,3.96,P ＜ 0.05).The incidences of hypersomnia,dizzy,nausea and vomiting were similar betwecn the two groups (x2 =0.12,0.54,0.54,0.02,P ＞ 0.05).Most of the adverse reactions would relieve or disappear after symptomatic treatment.Values of BUN,CR,ALT,AST were similar before and after treatment in group Ⅰ (t =1.43,1.67,0.91,0.11,P＞ 0.05).However,in group Ⅱ,these values were significantly increased after treatment (t =17.59,49.17,42.12,36.23,P ＜ 0.05).The heathrelated life quality (appetite,spirit,somnus,fatigue,daily life and countenance) were significantly improved after treatment in both groups (the group Ⅰ t =3.37,4.40,2.07,5.66,4.48,P ＜ 0.05; the group Ⅱ t =2.03,2.27,3.59,4.16,2.79,P ＜ 0.05),the spirit group Ⅰ improved more obviously compared with group Ⅱ (t =2.93,P ＜ 0.05).Conclusion Transdermal fentanyl patches provides equal pain relief compared with Morphine controlled-release tablets in the terminal cancer patients with abnormal hepatic and renal function and ascites.Transdermal fentanyl patches significantly improve health-related quality with less hepatic and renal function influence and low incidence of adverse reaction.It should be recommended in the treatment terminal cancer patients with moderate to serve pain combined with abnormal hepatic and renal function and ascites.
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<b>Introduction</b>: There has been no case report in which hyperpigmentation developed on the skin area where a transdermal fentanyl patch was applied in a patient. <b>Case report</b>: A 43-year-old man with recurrence of postoperative rectal cancer was treated by cetuximab plus irinotecan and panitumumab plus FOLFIRI. For cancer pain, transdermal fentanyl patch (Fentos®) was administered, and radiation from behind was performed. Hyperpigmentation then appeared on the chest and the abdominal skin sites where the patches were applied. The hyperpigmentation nearly disappeared four months after the fentanyl patch was discontinued. <b>Discussion</b>: The cause of the pigmentation was possibly due to post inflammatory hyperpigmentation secondary to contact dermatitis. It was desirable to conduct patch test and skin biopsy for making an accurate diagnosis. <b>Conclusion</b>: We should pay a careful attention to hyperpigmentation of the skin where a transdermal fentanyl patch is applied.
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Oxycodone controlled-release (CR) tablets are used as a first-line opioid analgesic for cancer pain. However, use of oxycodone CR tablets is associated with toxicities such as drowsiness and constipation, leading to deterioration of the quality of life (QOL), especially in patients with gynecologic cancer. In contrast, fentanyl has a superior toxicity profile while still showing a strong analgesic effect. Although fentanyl has been approved for switching from opioid, there have been no Japanese studies of patients with gynecologic cancer who were switched to transdermal fentanyl after experiencing toxicity during therapy with oxycodone CR. More importantly early introduction of palliative therapy for pain has not been adopted routinely in the management of gynecologic cancer. Thus, it appears that treatment for patients with gynecologic cancer remains unsatisfactory at present. We conducted research into improvement of the toxicity profile and pain control with the aim of improving QOL for patients with gynecologic cancer. We showed that pain, drowsiness, and constipation could be significantly improved in gynecologic cancer patients as a result of switching to transdermal fentanyl therapy at an early stage.
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OBJECTIVE: To evaluate the therapeutic efficacy of transdermal fentanyl patches for moderate to severe cancer pain in aspects of pain control, quality of life, ADR, and etc. METHODS: Using the standard case report form combined with brief pain inventory (BPI) and numerical rating scale (NRS), 39 patients with moderate to severe cancer pain who received transdermal fentanyl (initial dose of 25 μg · h-1) for no less than five weeks were investigated. RESULTS: The total effective rate was 97.4% (38/39) and the average pain relief degree was 60.3%. All the patients gained significant improvement in multiple aspects of the quality of life. The main ADRs included constipation, dizziness, nausea, drowsiness, skin itch and etc, which were endurable, especially in the later therapeutic period. CONCLUSION: Transdermal fentanyl patches are the ideal alternative for patients with moderate to severe cancer pain. Copyright 2012 by the Chinese Pharmaceutical Association.
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PURPOSE: Chronic low back pain is a common clinical problem. As medication, non-steroidal anti-inflammatory drugs are generally used; however, they are sometimes non-effective. Recently, opioids have been used for the treatment of chronic low back pain, and since 2010, transdermal fentanyl has been used to treat chronic non-cancer pain in Japan. The purpose of the current study was to examine the efficacy of transdermal fentanyl in the treatment of chronic low back pain. MATERIALS AND METHODS: This study included patients (n=62) that suffered from chronic low back pain and were non-responsive to non-steroidal anti-inflammatory drugs. Their conditions consisted of non-specific low back pain, multiple back operations, and specific low back pain awaiting surgery. Patients were given transdermal fentanyl for chronic low back pain. Scores of the visual analogue scale and the Oswestry Disability Index, as well as adverse events were evaluated before and after therapy. RESULTS: Overall, visual analogue scale scores and Oswestry Disability Index scores improved significantly after treatment. Transdermal fentanyl (12.5 to 50 microg/h) was effective in reducing low back pain in 45 of 62 patients; however, it was not effective in 17 patients. Patients who experienced the most improvement were those with specific low back pain awaiting surgery. Adverse events were seen in 40% of patients (constipation, 29%; nausea, 24%; itching, 24%). CONCLUSION: Disability Index scores in 73% of patients, especially those with specific low back pain awaiting surgery; however, it did not decrease pain in 27% of patients, including patients with non-specific low back pain or multiple back operations.
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Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Young Adult , Administration, Cutaneous , Chronic Disease , Fentanyl/administration & dosage , Low Back Pain/drug therapyABSTRACT
STUDY DESIGN: This is a multicenter, open-label prospective, non interventional study. PURPOSE: We wanted to evaluate the impact of fentanyl matrix on the pain and function of patients with spinal disorder-related chronic, non-malignant pain. OVERVIEW OF LITERATURE: Patients with severe non-malignant chronic low back pain may require opioid analgesics for effective pain management. METHODS: A total of 1,576 patients with severe pain (numeric rating scale = 7) were evaluated for their pain intensity at the initial visit and at weeks 4 and 8 (Visits 1, 2, and 3, respectively). Disturbances in sleep, daily living and social activities, the Oswestry Disability Index (ODI), the researchers' and patients' global assessment and the patients' treatment preference were also assessed. RESULTS: The pain intensity score significantly decreased from 8.1 at Visit 1 to 5.4 and 4.4 at Visits 2 and 3, respectively. Sleep disturbance also significantly decreased and the extent of disturbance of daily and social activities was also significantly improved. The ODI significantly decreased from 61.9% to 45.8% and 38.2% at Visits 1, 2, and 3, respectively. Adverse events were reported by 197 (12.5%) patients and severe adverse events were reported by 12 (0.76%) patients. Overall, 76.3% of the patients and 78.4% of the investigators rated the test drug as effective. CONCLUSIONS: The fentanyl matrix is believed to be effective for the treatment of pain, sleep disturbance and the impact upon daily and social activities, yet physicians should pay attention to the risks of abuse and the adverse events.
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Humans , Analgesics, Opioid , Chronic Pain , Fentanyl , Korea , Low Back Pain , Prospective Studies , Research Personnel , SpineABSTRACT
<b>Purpose</b>: The objective of this study was to investigate whether body fat rate (BFR) and triceps skinfold thickness (TSF) are associated with estimated fentanyl absorption in patients treated with the fentanyl transdermal matrix patch for moderate to severe cancer pain, by measuring the residual content of fentanyl in used matrix patches. <b>Methods</b>: Adult Japanese inpatients experiencing chronic cancer-related pain and receiving treatment for the first time with a transdermal fentanyl matrix patch (Durotep®MT patch) were included in the present study. During the initial application period, BFR was measured using a body fat scale, and TSF was measured by an experienced nurse with an adipometer. One patch was collected from each patient. The residual fentanyl content in used matrix patch was determined by high-performance liquid chromatography. The transdermal fentanyl delivery efficiency was estimated based on the fentanyl content of the used matrix patches. <b>Results</b>: Fifteen adult patients (5 males and 10 females) were included in this study. Nine patches with a release rate of 12.5μg/h and 6 patches with a release rate of 25μg/h were collected. The application site was the chest or upper arm. BFR and TSF both showed a significant positive correlation with delivery efficiency. <b>Conclusion</b>: In malnourished or low-body fat patients receiving DMP, pain intensity should be more carefully monitored, and fentanyl dose adjustment may be required. Additional parameters, such as nutritional status including body fat change, the degree of dry skin, and plasma fentanyl concentration, also require detailed evaluation. Palliat Care Res 2010; 5(2): 206-212
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BACKGROUND/AIMS: Pain is one of the most troublesome symptoms of pancreatitis. Transdermal fentanyl patches (TFPs) are long-acting analgesics with a reduced risk of dependency. This prospective study evaluated the effect of TFPs on sphincter of Oddi (SO) motility for the management of pain in pancreatitis. METHODS: SO manometry (SOM) was performed using triple-lumen catheters anterogradely inserted through the percutaneous transhepatic route during cholangioscopy in 16 patients. The basal pressure, amplitude, and frequency of the SO were assessed before and after applying a TFP at 24 hour at doses of 25 and 12.5microgram/hr, respectively. RESULTS: Two of 16 patients receiving a 25microgram/hr. TFP were excluded because of adverse side effects (headache and/or nausea). The mean basal pressure, amplitude, and frequency of SOM did not change significantly in the 25microgram/hr TFP group (n=4 patients). Parameters of SO function also did not significantly change in the 12.5microgram/hr TFP group (n=11 patients). CONCLUSIONS: TFPs below a dose of 25microgram/hr may not affect the motility of the SO. Administration of TFPs at lower dosages seems to be a safe analgesic treatment for the pain control of patients with pancreatitis without affecting the function of the SO.
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Humans , Analgesics , Catheters , Dependency, Psychological , Fentanyl , Manometry , Pancreatitis , Prospective Studies , Sphincter of OddiABSTRACT
BACKGROUND: The advances in surgical technology, anesthesia and perioperative care have made it possible to perform laparoscopic cholecystectomy on an outpatient basis. This study was conducted to assess the analgesic effect and the adverse events of different dosing methods when using transdermal fentanyl patches (TDFPs) after laparoscopic cholecystectomy. METHODS: Sixty patients who were to undergo laparoscopic cholecystectomy under general anesthesia were divided into two groups. Group 1: 2 TDFPs that released 12microgram/h were applied after the induction of anesthesia and these 2 patches were removed after 24 hours. Group 2: 2 TDFPs that released 12microgram/h were applied after the induction of anesthesia and one patch was removed after 7 hours and the other patch was removed after 24 hours. The intensity of the postoperative pain was assessed by using a visual analogue scale (VAS) and assessing the adverse events, including dizziness, pruritus and nausea/vomiting, were recorded for 48 hours postoperatively. RESULTS: The VAS score of postoperative pain was not significantly different between the two groups at all times. The incidence of dizziness in groups I and II was 10 and 3, respectively, and the incidence of nausea/vomiting in group I and II was 4 and 0, respectively. The incidences of dizziness and nausea/vomiting in group II were significantly lower than those of group I (P < 0.05). CONCLUSIONS: A dosing method that removes half of the TDFPs (24microgram/h) after 7 hours of application caused a lower incidence of dizziness and nausea/vomiting without any significant difference of postoperative analgesic efficacy, as compared to leaving on both the TDFPs (24microgram/h) for 24 hours after laparoscopic cholecystectomy.
Subject(s)
Humans , Anesthesia , Anesthesia, General , Cholecystectomy, Laparoscopic , Dizziness , Fentanyl , Incidence , Outpatients , Pain, Postoperative , Perioperative Care , PruritusABSTRACT
<b>Purpose</b>; Transdermal fentanyl (TF) has less systemic adverse effects as compared to morphine. However, few patients with cancer related pain obtain insufficient analgesic response despite the dose escalation of TF. The aims of this study were to describe patients with poor analgesic response and to evaluate the efficacy of opioid rotation from TF to oral morphine. <b>Case reports</b>; We conducted a retrospective chart review and analyzed six patients managed with opioid rotation in detail. Before opioid rotation, an average dose of TF was 204μg/hr. A significant decrease in pain score was found in all patients who switched to oral morphine, and five patients were treated with the combination of TF and oral morphine. <b>Conclusion</b>; These results may indicate that patients who are treated with relative high dose TF (over 200μg/hr) tended to response to poor analgesic, and opioid rotation is beneficial to restore the analgesic effects. We speculate that this clinical phenomenon is associated with opioid tolerance.
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A 60-year-old man was diagnosed with locally advanced non-small cell lung cancer. He refused treatment with a curative aim and was treated conservatively. Pain had developed on his shoulder and chest wall, which became worse as the cancer progressed. Although his pain initially appeared to be relieved with weak opioids and analgesics, it became more severe Strong opioids (transdermal fentanly patch and oxycodone), antidepressant or epidural block were introduced, However, the background pain became more intense and reached up to 8~9/10 on the visual analog scale (VAS). The dose of the transdermal fentanl patch was gradually increased to 600?g/hr, which resulted in a dramatic improvement in his pain (9/10 of VAS) to 3/10 for most of the time. We described the successful experience with a high dose transdermal fentanyl patch for cancer pain relief, which might be an alternative option for cancer patients suffering from severe pain.
Subject(s)
Humans , Middle Aged , Analgesics , Analgesics, Opioid , Carcinoma, Non-Small-Cell Lung , Fentanyl , Lung Neoplasms , Lung , Shoulder , Thoracic Wall , Visual Analog ScaleABSTRACT
BACKGROUND: Postherpetic neuralgia is a persistant pain which occurs after the reactivation of varicella zoster infection. It sometimes disrupts the lives of otherwise healthy individuals. A transdermal patch of analgesics such as fentanyl could be a novel and safe method, with less adverse problems, to relieve the prolonged pain in postherpetic neuralgia. OBJECTIVE: The aim of this study was to evaluate the analgesic effect and safety of transdermal fentanyl patch in intractable postherpetic neuralgia. METHODS: We applied a fentanyl patch on the chest for 6 days, changing it once on the fourth day. The severity of pain was evaluated by visual analogue scale (VAS), and was assessed before treatment, the first and third day after commencement of treatment, and 1 day after treatment had finished. Any side effects were also checked at each VAS assessment session. RESULTS: The average VAS pain score of the pretreatment, first, third, and seventh day were as follows; 82.9+/-8.8, 49.6+/-15.8, 45.0+/-16.5, 45.7+/-15.2. Postherpetic neuralgia was dramatically improved from the first day of treatment, and the improved state was maintained until 1 day after the treatment had finished (p<0.05). Several side effects such as contact dermatitis (9.5%), mild nausea (14.3%), and constipation (9.5%) were observed during the treatment. CONCLUSION: Fentanyl patch is an effective, simple and relatively safe method in the treatment of intractable postherpetic neuralgia.
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Analgesics , Chickenpox , Constipation , Dermatitis, Contact , Fentanyl , Herpes Zoster , Nausea , Neuralgia, Postherpetic , Thorax , Transdermal PatchABSTRACT
PURPOSE: Fentanyl is a synthetic opioid and transdermal therapeutic system (TTS), designed to release the drug into the skin at a constant rate, ranging from 25 to 100 microgram/hr, for up to 3 days. For the control of chronic cancer pain, Durogesic(R) patches (Janssen Co., USA) are now widely used. Recently, the Hana Company in Korea developed a new fentanyl patch, Fentas(R) using a different method. To compare the efficacy, and safety, of the fentanyl patch manufactured in Korea (Hana Pharm. Co. Ltd), with the Durogesic(R) patch, in controlling cancer pain, we performed randomized controlled, open labelled, phase III studies. MATERIALS AND METGODS: From January 2000 to April 2001, 85 patients were enrolled, 69 of whom (42 in D arm and 43 in F arm) completed the study, and were therefore assessable for per protocol (PP) analyses. RESULTS: There were no significant differences between the two groups in baseline characteristics, with the exception of age. The primary end point was to show the therapeutic equivalence of the two patches. In these clinical trials, the confidence interval of difference, between the test drug (Fentas(R)) and the control (Durogesic(R)), was 0.027~ +0.124 by intention to treat (ITT) analysis. Even if the upper confidence interval exceeds + 0.1, the test drug is not superior to the control drug, because the confidence interval includes 0. However, by PP analysis, the confidence interval lies exactly within +/- 0.1. Therefore, we could conclude the two patches are therapeutically equivalent. The second endpoint was the difference of visual analog scale (VAS) between the baseline and the average of three measurements after treatment. The difference in VAS was 50.44+/-10.28 for the F arm, and 44.69+/-11.00 for the D arm. By PP analysis the test drug was superior to the control (p=0.028). The rescue morphine amount was 81.21+/-124.76 for F arm and 66.19+/-115.9 for D arm, and there was no significant difference between the two groups (p=0.6063). The most common adverse effects of both fentanyl patches were nausea or vomiting (55.3%), somnolence (50.0%), constipation (39.5%), gastrointestinal discomfort (57.9%) and headaches (25.0%). In general there was no significant difference in side effects or laboratory data between the two groups. CONCLUSION: These findings suggest that Fentas(R) patches, administered every 3 days, are effective, safe, and well tolerated for the treatment of most patients with cancer pain and is as effective or better than Durogesic(R).
Subject(s)
Humans , Arm , Constipation , Fentanyl , Headache , Intention , Korea , Morphine , Nausea , Skin , Visual Analog Scale , VomitingABSTRACT
OBJECTIVE:To observe the analgesia effects of transdermal fentanyl in the treatment of pharynx oralis pain caused by radiotherapy.METHODS:30patients with pate squamous carcinoma and serious membrana mucosa ulcerate and pain after a whole range radiotherapy,who were treated with3to5patches2.5mg(25?g/h)of transdermal fentanyl every9～15days if their VAS scores were found to be more than6scores.The analgesia effect,life quality and the adverse reaction were evaluated respectively with VAS,Digit-scale and east American carcinoma cooperation group toxicity criteria.RESULTS:The average VAS scores has been lowered from7.86?1.18before the treatment to2.24?1.31on10th day of the treatment(P
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Purpose:To study analgesia effect ,adverse reactions and life quality changes of transdermal fentanyl in patients with cancer pain.Methods:30 patients with moderate or severe cancer pain were treated by transdermal fentanyl .The pain intensity, quality of life and adverse reactions were observed before and after the treatment.Results:After using transdermal fentanyl ,all the patients obtained moderate to good remission.The excellent,marked and moderate rates were 43.33%,53.33% and 3.33% respectively. The adverse reactions included nausea, vomiting,constipation,dizziness and lethargy.The rate of the adverse reactions was less.The quality of life improved markedly. Conclusions:Transdermal fentanyl is a safe,effective and simple way to relieve cancer pain in patients with moderate or severe pain.It can improve the quality of life markedly.Its adverse reactions are mild.