Publications by authors named "Raymond S Sinatra"

Objective: This analysis compared opioid-related adverse events (ORADEs) observed with fentanyl iontophoretic transdermal system (ITS) versus morphine intravenous (iv.) patient-controlled analgesia (PCA) in the management of postoperative pain.

Methods: Safety data from four Phase IIIB randomized, active-comparator trials were pooled for this analysis (n = 1288 fentanyl ITS and 1313 morphine iv.

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Objective: This meta-analysis was conducted to analyze and compare the efficacy outcomes associated with the fentanyl iontophoretic transdermal system (ITS) and morphine intravenous (IV) patient-controlled analgesia (PCA) in the management of postoperative pain.

Research Design And Methods: This meta-analysis assessed the efficacy of the fentanyl ITS versus morphine IV PCA using data from four randomized, active-controlled trials (n = 1271 fentanyl ITS and 1298 morphine IV PCA patients). Main outcome measures were patient global assessment (PGA) of the method of pain control at 24 h.

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Objective: To evaluate the pharmacokinetic (PK) characteristics of a modified fentanyl iontophoretic transdermal system (ITS).

Research Design And Methods: This was a prospective, open-label, single-center, randomized, 3-period, 5-treatment, 6-sequence study. Each subject was randomly assigned to receive three treatments in a sequence consisting of intravenous fentanyl citrate, fentanyl ITS at 170 μA, and then one of three other fentanyl ITS treatments at 140, 200 or 230 μA.

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Many patients who undergo hip or knee replacement surgery today experience high levels of postoperative pain. Data from clinical studies and analyses of hospital records have demonstrated that severe postoperative pain is associated with an increased risk for complications, slowing of the rehabilitation process, delayed return to normal functioning, progression to persistent pain states, prolonged length of hospital stay, elevated rates of readmission, and higher overall costs. Orthopedic surgeons may now play a more active role in reducing the severity of pain following surgery, decreasing both opioid use and the incidence of opioid-related adverse events, and eliminating breakthrough pain and analgesic gaps.

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Despite advances in pharmacologic options for the management of surgical pain, there appears to have been little or no overall improvement over the last two decades in the level of pain experienced by patients. The importance of adequate and effective surgical pain management, however, is clear, because inadequate pain control 1) has a wide range of undesirable physiologic and immunologic effects; 2) is associated with poor surgical outcomes; 3) has increased probability of readmission; and 4) adversely affects the overall cost of care as well as patient satisfaction. There is a clear unmet need for a national surgical pain management consensus task force to raise awareness and develop best practice guidelines for improving surgical pain management, patient safety, patient satisfaction, rapid postsurgical recovery, and health economic outcomes.

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Background And Methods:   From the time that Sinatra et al. (Anesthesiology. 2005;102:822) was published to FDA apaproval of intravenous (IV) acetaminophen, an expanded analysis of the original raw study data became necessary for the regulatory submission.

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A very rare, but important, risk factor in placement of epidural catheters is skin reactions to the antiseptic solution, adhesive tape, or the catheter itself. We describe a case of a severe inflammatory cutaneous reaction after continuous epidural analgesia used after an abdominal perineal resection. We highlight the importance of making the proper diagnosis and initiating timely therapy.

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The Acute Pain Summit 2005 was convened to critically examine the perceptions of physicians about current methods used to control postoperative pain and to compare those perceptions with the available scientific evidence. Clinicians with expertise in treatment of postsurgical pain were asked to evaluate 10 practice-based statements. The statements were written to reflect areas within the field of acute-pain management, where significant questions remain regarding everyday practice.

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The adverse effects of opioids are well documented. Because opioid receptors have a wide-ranging anatomic distribution, the effects subsequent to opioid binding, both good and bad, occur centrally and in the periphery. Postoperative strategies to reduce opioid burden, therefore, are in the patient's best interest.

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Background And Objectives: In this randomized, placebo-controlled, double-blind study, the efficacy and safety of rofecoxib 50 mg was evaluated in patients undergoing major abdominal gynecologic surgery.

Methods: Patients were randomized to receive rofecoxib 50 mg (n = 81) or placebo (n = 83) approximately 2 hours before total abdominal hysterectomy or myomectomy and once daily over the ensuing 4 days. Clinical measurements included average daily opioid use over the 5-day period (primary endpoint), pain intensity on movement, and opioid-related side effects.

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Background: Intravenous acetaminophen injection (paracetamol) is marketed in Europe for the management of acute pain. A repeated-dose, randomized, double-blind, placebo-controlled, three-parallel group study was performed to evaluate the analgesic efficacy and safety of intravenous acetaminophen as compared with its prodrug (propacetamol) and placebo. Propacetamol has been available in many European countries for more than 20 yr.

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Unlabelled: Rofecoxib is a selective cyclooxygenase-2 inhibitor that reduces pain and inflammation without inhibiting platelet function. We examined its effects on effort-dependent pain, postoperative morphine requirements, and pulmonary function in 48 patients recovering from open abdominal surgery. Spirometric measurement of forced expiratory volume(1) and vital capacity (FVC) were assessed preoperatively.

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Objective: This study assessed conversion factors utilized by physicians to transfer postoperative patients from intravenous opioids to oral controlled-release (CR) oxycodone and the subsequent analgesic effectiveness.

Design: This was a multicenter, open-label, usual-use study of 189 hospitalized postoperative patients receiving opioid (usually morphine) intravenous patient-controlled analgesia (IV PCA) for at least 12 to 24 hours post-procedure. Patients who were tolerant of oral medications and without signs of paralytic ileus were converted to oral CR oxycodone, given every 12 hours for up to 7 days.

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We evaluated a continuous epidural infusion containing bupivacaine 0.05% plus the opioid hydromorphone in 1830 women requesting pain relief during labor and delivery. The infusion provided effective analgesia with minimal adverse events for patients differing in parity and at varying stages of labor.

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Several recently developed analgesic techniques effectively control pain after major orthopaedic surgery. Neuraxial analgesia provided by epidural and spinal administration of local anesthetics and opioids provides the highest level of pain control; however, such therapy is highly invasive and labor intensive. Neuraxial analgesia is contraindicated in patients receiving low-molecular-weight heparin.

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