Richard Rauck

Carolinas Pain Institute, Winston-Salem, North Carolina, United States

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Publications (141)494.2 Total impact

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    ABSTRACT: Purpose The current study assessed the long-term safety of fentanyl sublingual spray for managing breakthrough cancer pain (BTCP). Methods This open-label, multicenter study enrolled both de novo and rollover patients who completed a double-blind, efficacy trial. Eligible patients were ≥18 years of age and experiencing pain that was being managed with an around-the-clock opioid yet were experiencing ≤4 BTCP episodes daily and were opioid-tolerant (i.e., receiving ≥60 mg/day oral morphine or an equivalent dose of another opioid for ≥1 week). De novo patients initially entered a 21-day titration period to identify an effective dose of fentanyl sublingual spray (100–1600 μg), then entered a 90-day maintenance period. The incidence of adverse events (AEs), results of laboratory tests, vital sign assessments, and treatment satisfaction were assessed. Results Of the 269 patients (de novo, 179; rollover, 90) who entered the maintenance period, 163 (60.6 %) completed the study; the primary reason for discontinuation was an AE (22.3 %). Eighty percent of patients identified an effective dose of fentanyl sublingual spray (median dose, 600 μg). The most common AEs differed from the titration period (nausea (13 %), vomiting (12 %), and somnolence (10 %)) to the maintenance period (malignant neoplasm progression (24 %), vomiting (16 %), and peripheral edema (12 %)). Few changes in laboratory parameters and vital sign assessments were observed. Patients generally reported being more satisfied with fentanyl sublingual spray than with their previous BTCP treatment. Conclusions This long-term maintenance study demonstrated that fentanyl sublingual spray was generally safe and well tolerated for managing BTCP over a 90-day period.
    No preview · Article · Jan 2016 · Supportive Care Cancer
  • Richard L. Rauck · Jeffrey Potts · Qinfang Xiang · Evan Tzanis · Andrew Finn
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    ABSTRACT: Objectives: Buprenorphine HCl buccal film has been developed for treating chronic pain utilizing BioErodible MucoAdhesive (BEMA(®)) delivery technology. Buccal buprenorphine (BBUP; Belbuca(TM), Endo Pharmaceuticals) was evaluated for the management of moderate to severe chronic low back pain (CLBP) requiring around-the-clock analgesia in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-naive patients. Methods: Patients (n=749) were titrated to a dose of BBUP (range, 150-450 µg every 12 hours) that was generally well tolerated and provided adequate analgesia for ≥14 days, and then randomized to BBUP (n=229) or placebo (n=232), respectively. The primary efficacy variable was the change from baseline to week 12 of double-blind treatment in the mean of daily average pain intensity scores (numeric rating scale from 0 [no pain] to 10 [worst pain imaginable]). Results: Patients were experiencing moderate to severe pain at study entry: mean (SD)=7.15 (1.05). Following titration, pain was reduced to the mild range; 2.81 (1.07). After randomization, mean (SD) pain scores increased from baseline to week 12 more with placebo (1.59 [2.04]) versus BBUP: (0.94 [1.85]) with a significant between-group difference (-0.67 [95% CI: -1.07 to -0.26]; P=0.0012). A significantly larger percentage of patients receiving BBUP versus placebo had ≥30% pain reduction (63% vs 47%; P=0.0012). During double-blind treatment, the most frequent adverse events (AEs) with BBUP were nausea (10%), constipation (4%), and vomiting (4%). The most common AEs with placebo were nausea (7%), upper respiratory tract infection (4%), headache (3%), and diarrhea (3%). Conclusions: These findings demonstrate the efficacy and tolerability of BBUP among opioid-naive patients requiring around-the-clock opioid treatment for CLBP.
    No preview · Article · Dec 2015 · Postgraduate Medicine
  • Richard Rauck · Janet Bull · Neha Parikh · Larry Dillaha · Lisa Stearns
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    ABSTRACT: Objective: To further describe effective dose titration of fentanyl sublingual spray to treat breakthrough cancer pain (BTCP) during the 26-day open-label titration phase of a phase 3, randomized, double-blind, placebo-controlled study. Methods: Opioid-tolerant patients with 1 to 4 episodes of BTCP per day were enrolled. For randomization into double-blind treatment, patients must have titrated to a dose (100 to 1,600 mcg) providing effective analgesia for 2 consecutive BTCP episodes. The Treatment Satisfaction Questionnaire for Medication was administered at baseline and at titration end and included a Global Satisfaction domain. Results: Of 130 patients undergoing titration, 98 (75%) achieved pain relief (median dose = 800 mcg). The most common doses that allowed for adequate pain relief were 800 mcg (24.5%) and 1,200 mcg (20.4%). Of 32 (25%) patients who withdrew from the study, only 3 (2.3%) did not achieve an effective dose. In patients attaining an effective dose, mean Global Satisfaction increased from 54.9 ± 2.1 at baseline to 75.3 ± 1.7 at the end of the titration phase. Seventy-eight patients (60%) reported ≥ 1 adverse event (AE). Thirty-three AEs (25.4%) were considered probably related to treatment, with nausea (6.2%) and somnolence (4.6%) most commonly reported. Conclusions: In patients with BTCP, fentanyl sublingual spray can be rapidly and safely titrated to an effective dose, resulting in greater satisfaction with fentanyl sublingual spray than previous BTCP medications.
    No preview · Article · Oct 2015 · Pain Practice
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    ABSTRACT: To understand how patient demographics and patient-reported disease characteristics relate to successful management of postherpetic neuralgia (PHN), integrated data from Phase 3 and Phase 4 studies of patients with PHN (n=546) who received once-daily gastroretentive gabapentin (G-GR, 1800 mg) were analyzed. There were widespread, networked, positive correlations among efficacy endpoints—pain qualities on the Visual Analog Scale (VAS) and Brief Pain Inventory (BPI), measures of pain interference on the BPI, and Patient Global Impression of Change (PGIC)—most likely characterized by positive feedback loops, in which pain interferes with patient functioning, and poor functioning enhances pain. VAS scores at baseline or at Week 2 were the strongest predictors of being “Much” or “Very Much” improved on the PGIC; BPI sleep interference scores were the strongest predictors of percent changes in BPI pain qualities and in the average of BPI interference scores; whereas age, sex, and race were not important predictors. In addition to VAS, BPI sleep interference and PGIC assessments appeared to be key co-strategic factors important for successful treatment outcomes, and should be considered as co-primary endpoints in future clinical trials of PHN. This could improve detection of true positive efficacy responses and guide successful transition to real-world clinical practice.
    Preview · Article · Sep 2015 · The journal of pain: official journal of the American Pain Society
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    ABSTRACT: Chronic opioid analgesic use often causes opioid-induced constipation (OIC). This open-label extension study evaluated the safety and efficacy of lubiprostone, a chloride channel (ClC-2) activator, for treatment of OIC in patients with chronic noncancer pain. Adults with OIC were enrolled from two 12-week, placebo-controlled, double-blind studies and received lubiprostone 24 μg twice daily for up to 9 months. OIC was defined as < 3 spontaneous bowel movements (SBMs)/week during the 2-week baseline period, of which ≥ 25% were characterized by hard to very hard stool consistency, subjectively incomplete evacuation, and/or moderate or worse straining. Inclusion criteria required consistent treatment with full opioid agonists ≥ 30 days prior to screening and throughout the study. All 439 patients who received lubiprostone were analyzed for safety and efficacy. Overall, 24.6% of patients reported treatment-related adverse events (AEs), most commonly nausea (5.0%), diarrhea (4.6%), headache (1.6%), and vomiting (1.4%). No treatment-related serious AEs were reported. Nausea and diarrhea each led to study discontinuation in 5 patients (1.1%); 2 cases each of nausea and diarrhea were rated as severe. Rescue medication usage decreased from month 1 (33.0%) to month 9 (18.6%). Mean weekly SBM frequency (1.4) was significantly increased from baseline at all months (P < 0.001, range 4.9 to 5.3). Straining, abdominal bloating, abdominal discomfort, stool consistency, constipation severity, and bowel habit regularity were significantly improved from baseline at all months (P < 0.001). Lubiprostone treatment was well tolerated and improved symptoms and signs of OIC in this 9-month, open-label study of patients with chronic noncancer pain. © 2015 World Institute of Pain.
    No preview · Article · Aug 2015 · Pain Practice
  • James M. North · Kyung‐soo J. Hong · Richard L. Rauck
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    ABSTRACT: IntroductionWe assessed the efficacy and safety of extended-release gabapentin in a 15-week, open-label, single-arm, single-center study in patients with fibromyalgia (FM).Methods Subjects with documented diagnosis of FM were allowed to participate in the study. We opened enrollment to those who have tried and failed gabapentinoids such as gabapentin or pregabalin due to side effects. Subjects with autoimmune conditions, and or taking opioids for management of their FM pain, were excluded from the study. Subjects were given an extended-release gabapentin starter pack and treated for total of 12 weeks. The primary study endpoint of pain relief was measured using Numeric Pain Rating System (NPRS) scores, and secondary study endpoints were measured with Fibromyalgia Impact Questionnaire (FIQ), Patient's Global Impression of Change (PGIC), and Medical Outcome Sleep questionnaires (MOS).ResultsA total of 34 subjects were enrolled and 29 subjects completed the starter pack (85%). Patients reported significant pain relief on NPRS by end of 4 weeks (P < 0.0001) on NPRS. Subjects also reported similar magnitude of improvements in FM and its impact on daily life by end of 4 weeks on FIQ (P < 0.0001). Survey of MOS showed our subjects reporting improved sleep quantity (on average, 1.2 hours over baseline) with gradual and statistically significant improvement in quality. Improvements in primary and secondary measurements were reflected in PGIC, with significant improvement in patient's impression of FM by week 8.LimitationsSmall sample size, geographical bias, relatively short duration of treatment, and single-arm study without control group.Conclusions Extended-release gabapentin relieved FM pain symptoms and improved quality-of-life for the FM subjects studied. Subjects reported improvements in both quantity and quality of sleep.
    No preview · Article · Jun 2015 · Pain Practice
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    ABSTRACT: The objective of this multicenter, double-blind, placebo-controlled, randomized withdrawal study was to evaluate the efficacy and safety of ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride (HCl) surrounding sequestered naltrexone HCl, compared with placebo in the treatment of moderate-to-severe chronic low back pain(CLBP). An open-label titration period in which all patients received ALO-02 was followed by a double-blind treatment period where patients meeting treatment response criteria were randomized to either a fixed dose of ALO-02 or placebo. Daily average low back pain was assessed using an 11-point numeric rating scale (NRS)-Pain. Of the 663 patients screened, 410 received ALO-02 during the open-label conversion and titration period and 281 patients were randomized to the double-blind treatment period (n=134, placebo; n=147, ALO-02). Change in mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo (P=0.0114). 57.5% of patients treated with ALO-02 and 44.0% of patients treated with placebo reported ≥30% improvement in weekly average NRS-Pain scores from screening to final 2 weeks of the treatment period (P=0.0248). In the double-blind treatment period, 56.8% of patients in the ALO-02 group and 56.0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE). The most common treatment-related TEAEs for ALO-02 during the treatment period were nausea, vomiting, and constipation, consistent with opioid therapy. ALO-02 has been demonstrated to provide significant reduction of pain in patients with CLBP and has a safety profile similar to other opioids.
    No preview · Article · May 2015 · Pain
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    ABSTRACT: Oral clonidine is used to treat hypertension but often produces sedation and severe dry mouth; intrathecal clonidine is used to treat chronic pain but may produce hypotension. This clinical feasibility study was conducted to determine if intrathecal clonidine decreases blood pressure in patients with poorly controlled hypertension. This prospective, single-arm, open-label study was conducted in ten subjects who were taking at least three antihypertensive medications including a diuretic and had an in-office systolic blood pressure between 140 and 190 mm Hg. On the day of treatment, blood pressure was measured before and after a single lumbar intrathecal dose (150 mcg) of clonidine using an automatic oscillometric device every 10-15 min for four hours. Student's paired t-test was used for statistical comparisons. Maximal reductions in systolic and diastolic blood pressures averaging 63 ± 20/29 ± 13 mm Hg were observed approximately two hours after clonidine administration. Decreases in systolic pressure were strongly correlated with baseline systolic pressure. Clonidine produced a significant decrease in heart rate of 11 ± 7 beats/min. No subject required intravenous fluids or vasopressor rescue therapy, or reported spinal headache. This is the first clinical study in subjects with hypertension that demonstrates significant and profound acute reductions in blood pressure after a single dose of intrathecal clonidine. Future placebo-controlled, dose-escalating studies are warranted to assess the long-term effects of intrathecal clonidine infusion via an implantable drug pump in patients with treatment-resistant hypertension at risk of stroke or myocardial infarction. © 2015 International Neuromodulation Society.
    Full-text · Article · May 2015 · Neuromodulation
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    ABSTRACT: Interventional spine and pain procedures cover a far broader spectrum than those for regional anesthesia, reflecting diverse targets and goals. When surveyed, interventional pain and spine physicians attending the American Society of Regional Anesthesia and Pain Medicine (ASRA) 11th Annual Pain Medicine Meeting exhorted that existing ASRA guidelines for regional anesthesia in patients on antiplatelet and anticoagulant medications were insufficient for their needs. Those surveyed agreed that procedure-specific and patient-specific factors necessitated separate guidelines for pain and spine procedures.In response, ASRA formed a guidelines committee. After preliminary review of published complication reports and studies, committee members stratified interventional spine and pain procedures according to potential bleeding risk as low-, intermediate-, and high-risk procedures. The ASRA guidelines were deemed largely appropriate for the low- and intermediate-risk categories, but it was agreed that the high-risk targets required an intensive look at issues specific to patient safety and optimal outcomes in pain medicine.The latest evidence was sought through extensive database search strategies and the recommendations were evidence-based when available and pharmacology-driven otherwise. We could not provide strength and grading of these recommendations as there are not enough well-designed large studies concerning interventional pain procedures to support such grading. Although the guidelines could not always be based on randomized studies or on large numbers of patients from pooled databases, it is hoped that they will provide sound recommendations and the evidentiary basis for such recommendations.
    No preview · Article · May 2015 · Regional anesthesia and pain medicine
  • R. Rauck · J. Potts · Q. Xiang · E. Tzanis · A. Finn

    No preview · Article · Apr 2015 · Journal of Pain
  • Richard L Rauck

    No preview · Article · Feb 2015 · Pain Medicine
  • Richard L Rauck · James North · James C Eisenach
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    ABSTRACT: Chronic pain may be accompanied by hyperalgesia and allodynia, and analgesic interventions may reduce these hypersensitivity phenomena. Preclinical data suggest that intrathecal clonidine and adenosine reduce hypersensitivity, but only clonidine reduces pain; therefore, we tested the effects of these interventions in patients with chronic pain. Twenty-two subjects with pain and hyperalgesia in a lower extremity from complex regional pain syndrome were recruited in a double-blind crossover study to receive intrathecal clonidine, 100 μg, or adenosine, 2 mg. Primary outcome measure was proportion with ≥30% reduction in pain 2 hours after injection, and secondary measures were pain report, areas of hypersensitivity, and temporal summation to heat stimuli. Treatments did not differ in the primary outcome measure (10 met success criterion after clonidine administration and 5 after adenosine administration), although they did differ in pain scores over time, with clonidine having a 3-fold greater effect (P = 0.014). Both drugs similarly reduced areas of hyperalgesia and allodynia by approximately 30% and also inhibited temporal summation. The percentage change in pain report did not correlate with the percentage change in areas of hyperalgesia (P = 0.09, r = 0.08) or allodynia (P = 0.24, r = 0.24) after drug treatment. Both intrathecal clonidine and adenosine acutely inhibit experimentally induced and clinical hypersensitivity in patients with chronic regional pain syndrome. Although these drugs do not differ in analgesia by the primary outcome measure, their difference in effect on pain scores over time and lack of correlation between effect on pain and hypersensitivity suggest that analgesia does not parallel antihyperalgesia with these treatments.
    No preview · Article · Jan 2015 · Pain
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    ABSTRACT: To evaluate the long-term safety, tolerability, and effectiveness of single-entity extended-release hydrocodone in opioid-experienced subjects with moderate to severe chronic pain not receiving adequate pain relief or experiencing intolerable side effects from their current opioid. This multicenter, open-label study started with a conversion/titration phase (≤6 weeks) where subjects (n=638) were converted to individualized doses (range 20-300 mg) of extended-release hydrocodone dosed every 12 hours, followed by a 48-week maintenance phase (n=424). The primary objective (safety and tolerability) and the secondary objective (long-term efficacy as measured by change in average pain score; 0= no pain, 10= worst imaginable pain) were monitored throughout the study. Subjects were treated for a range of chronic pain etiologies, including osteoarthritis, low back pain, and neuropathic and musculoskeletal conditions. The mean hydrocodone equivalent dose at screening was 68.9±62.2 mg/day and increased to 139.5±81.7 mg/day at the start of the maintenance phase. Unlimited dose adjustments were permitted at the investigator's discretion during the maintenance phase, reflecting typical clinical practice. No unexpected safety issues were reported. Common adverse events during the conversion/titration and maintenance phases, respectively, were constipation (11.3% and 12.5%), nausea (10.7% and 9.9%), vomiting (4.1% and 9.7%), and somnolence (7.7% and 4.2%). Four deaths occurred during the study; all were considered unrelated to treatment. One subject died 13 months after the study ended. From the start to end of the conversion/titration phase, 84% of subjects had a clinically meaningful improvement in average pain score (≥30% improvement), and the mean average pain scores remained stable through the maintenance phase. This single-entity, extended-release formulation of hydrocodone was generally safe, well tolerated, and effective in reducing chronic pain for 48 weeks. This formulation provides a new option for patients experiencing chronic pain, especially those who are taking immediate-release hydrocodone and have concerns about liver toxicity due to acetaminophen.
    Full-text · Article · Nov 2014 · Journal of Pain Research
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    ABSTRACT: IntroductionDiscogenic low back pain (LBP) affects a considerable number of patients suffering from chronic LBP. Recently, a growing interest has emerged in minimally invasive treatment options for discogenic LBP. Intradiscal biacuplasty (IDB), which uses cooled radiofrequency technology to ablate nociceptors in the posterior aspect of the intervertebral disc, is one such option. We previously presented 6-month results of a randomized, double-blinded, sham-controlled study. Now, we present the unblinded, 12-month follow-up data for treatment patients and 6-month data for cross-over subjects from the original sham group.Methods Physical function, pain relief, and disability were assessed using the Short Form-36, numerical rating scale, and Oswestry Disability Index, respectively. Subjects were unblinded at 6 months, and those initially randomized to sham procedure were given the option to cross over to IDB.ResultsTwenty-two out of 27 subjects in the original active treatment group were followed until 12 months and had clinically significant improvements in physical function (Δ = 22) and pain (Δ = −2.9). Out of 30 subjects originally in the sham group, 24 chose to cross over, and 20 cross-over patients completed follow-up at 6 months. In cross-over patients, improvements in physical function and pain did not differ statistically from those of patients originally randomized to IDB treatment. No complications or adverse events related to the procedure were reported.Conclusions Clinically significant improvements after IDB initially reported at 6 months were maintained at 9 and 12 months. The cross-over subjects had similar improvement in all outcome measures at all observed time points.
    No preview · Article · Nov 2014 · Pain Medicine
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    ABSTRACT: Complex regional pain syndrome (CRPS) is a potentially debilitating chronic pain syndrome with a poorly understood but likely neuroimmune/multifactorial pathophysiology associated with axonal injury. Based on the potential contribution of pro-inflammatory cytokines to CRPS pathogenesis and prior research with thalidomide, we investigated lenalidomide, a thalidomide derivative, for CRPS treatment. We conducted a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral lenalidomide 10 mg once daily in consenting patients with unilateral or bilateral CRPS type 1. The study comprised 12 weeks of treatment followed by a long-term extension. The primary efficacy outcome was reduced pain in the index limb, defined as ≥30% improvement from baseline using an 11-point numerical rating scale. One hundred eighty-four subjects enrolled. The primary endpoint was not met because equal proportions of treated (16.1%) and control (16.1%) subjects achieved the outcome; however, lenalidomide was well tolerated with no evidence of neuropathy or major adverse effects. This study is the largest, controlled, blinded, clinical trial in subjects with chronic CRPS using the Budapest research criteria. It demonstrates the feasibility of conducting high-quality clinical trials in CRPS type 1 and provides considerations for designing future trials. Perspective This article reports an adequately powered, controlled clinical trial in subjects with CRPS. Both treatment and placebo were equally effective, but the study demonstrated that lenalidomide treatment is feasible in this population. The study provides examples to consider in designing future CRPS trials.
    Full-text · Article · Oct 2014 · Journal of Pain
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    ABSTRACT: Introduction: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications. Methods: The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar. Results: Neurostimulation is relatively safe because of its minimally invasive and reversible characteristics. Comparison with medical management is difficult, as patients considered for neurostimulation have failed conservative management. Unlike alternative therapies, neurostimulation is not associated with medication-related side effects and has enduring effect. Device-related complications are not uncommon; however, the incidence is becoming less frequent as technology progresses and surgical skills improve. Randomized controlled studies support the efficacy of spinal cord stimulation in treating failed back surgery syndrome and complex regional pain syndrome. Similar studies of neurostimulation for peripheral neuropathic pain, postamputation pain, postherpetic neuralgia, and other causes of nerve injury are needed. International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated. Conclusions: Appropriate neurostimulation is safe and effective in some chronic pain conditions. Technological refinements and clinical evidence will continue to expand its use. The NACC seeks to facilitate the efficacy and safety of neurostimulation.
    Full-text · Article · Aug 2014 · Neuromodulation
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    ABSTRACT: Objectives Breakthrough cancer pain (BTCP) is associated with decreased satisfaction with around-the-clock opioid therapy. This analysis examined patient satisfaction with fentanyl sublingual spray for BTCP during the open-label titration period of a randomized, placebo-controlled study.Methods Opioid-tolerant patients with 1 to 4 daily BTCP episodes were included. During a 26-day, open-label titration phase, a successful dose (100 to 1600 mcg) of fentanyl sublingual spray was established that provided effective analgesia for 2 consecutive BTCP episodes with tolerable side effects. The Treatment Satisfaction Questionnaire for Medication (TSQM) was administered at baseline to assess satisfaction with previous BTCP medication and at the end of the titration to assess satisfaction with fentanyl sublingual spray.ResultsOf 130 enrolled patients, 115 (88.5%) had a TSQM measure at baseline and at the end of their titration period. Scores on all 4 TSQM domains increased from baseline to end of the titration, with mean (standard error [SE]) improvements of 22.3 (2.3) for effectiveness, 7.7 (3.2) for side effects, 6.8 (2.2) for convenience, and 12.9 (2.8) for global satisfaction (P < 0.05 for all). Satisfaction with symptom relief (26.1% to 77.4%) and onset of action (21.7% to 82.6%) also improved from baseline to end of titration. At least one adverse event (AE) was reported by 78 patients (60.0%). The most common AEs considered possibly or probably related to study medication were dizziness, somnolence, and nausea (n = 10 [7.7%] each).DiscussionThese data indicate markedly improved satisfaction among patients receiving fentanyl sublingual spray relative to previous BTCP medications.
    No preview · Article · Jul 2014 · Pain Practice
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    ABSTRACT: Objective: To examine the relationship between the dose of fentanyl sublingual spray needed to control breakthrough cancer pain (BTCP) and the dose of around-the-clock (ATC) opioid used to control background pain. Design: Analysis was based on the open-label, dose-titration phase (up to 26 days) of a randomized, double-blind, placebo-controlled trial. Patients: Opioid-tolerant cancer patients (aged ≥18 years) with chronic pain of ≤moderate severity in the 24 hours before screening while receiving stable doses of scheduled ATC opioid therapy for ≥1 week and 1 to 4 episodes of BTCP per day. Interventions: Fentanyl sublingual spray was initiated at 100 µg. Dose titration proceeded until a dose was reached that provided adequate pain relief for two consecutive BTCP episodes without intolerable adverse effects (AEs). Results: Overall, 98/130 (75.4 percent) patients completed the dose-titration phase and achieved pain relief, and 73.5 percent of those who completed the titration period attained an effective dose of ≥600 µg (median effective dose, 800 µg). No clinically relevant correlation was found between effective doses of fentanyl sublingual spray for the treatment of BTCP and the ATC opioid doses used to control persistent pain (Spearman rank correlation [rs]=0.351, n=98). Sixty percent of patients reported ≥1 AE during the dose-titration phase. The most common AEs considered related to study treatment were nausea (6.2 percent), somnolence (4.6 percent), dizziness (3.8 percent), and vomiting (3.8 percent). Conclusions: These findings highlight the importance of titrating the dose of fentanyl sublingual spray to optimize dosing for individual patients.
    No preview · Article · Jul 2014 · Journal of opioid management
  • R. Rauck · L. Stearns · N. Forman · N. Parikh · L. Dillaha

    No preview · Article · Apr 2014 · Journal of Pain

  • No preview · Article · Apr 2014 · Journal of Pain

Publication Stats

4k Citations
494.20 Total Impact Points


  • 2006-2016
    • Carolinas Pain Institute
      • Center for Clinical Research
      Winston-Salem, North Carolina, United States
  • 2008-2014
    • North Carolina Clinical Research
      Raleigh, North Carolina, United States
    • Winston-Salem State University
      Winston-Salem, North Carolina, United States
  • 1991-2012
    • Wake Forest University
      • Department of Anesthesiology
      Winston-Salem, North Carolina, United States
  • 2011
    • The University of Arizona
      Tucson, Arizona, United States
  • 1998-2010
    • Wake Forest School of Medicine
      • Department of Anesthesiology
      Winston-Salem, North Carolina, United States
  • 2007
    • West Virginia University
      MGW, West Virginia, United States
  • 2005
    • Virginia Commonwealth University
      Richmond, Virginia, United States
  • 1986
    • University of Cincinnati
      Cincinnati, Ohio, United States