The Analgesic Efficacy and Safety of a Novel Intranasal Morphine Formulation (Morphine plus Chitosan), Immediate Release Oral Morphine, Intravenous Morphine, and Placebo in a Postsurgical Dental Pain Model

2008 ◽  
Vol 107 (6) ◽  
pp. 2018-2024 ◽  
Author(s):  
Kyle S. Christensen ◽  
Amy E. Cohen ◽  
Fred H. Mermelstein ◽  
Douglas A. Hamilton ◽  
Ewan McNicol ◽  
...  
1993 ◽  
Vol 11 (5) ◽  
pp. 973-978 ◽  
Author(s):  
P A Glare ◽  
T D Walsh

PURPOSE AND METHODS We assessed the analgesic efficacy and safety of single-entity oxycodone solution at doses greater than 10 mg orally every 4 hours in 24 patients with chronic cancer pain not controlled by weaker analgesics. RESULTS Twenty of 24 patients completed the study. Pain relief was obtained with doses up to 60 mg every 4 hours. When oxycodone was taken for long periods, further dose increments could be made safely. The side effects of oxycodone are mild, and common to all opioids, with sedation and constipation most frequent. Nausea was more common in females in all age groups and in patients of either sex less than 50 years of age. Episodes of serious toxicity were rare, and responded to dose reduction. Patients older than 65 years required lower doses, suggesting pharmacokinetic similarities between oxycodone and morphine. Patients changed from oral oxycodone to morphine remained pain-free when relative milligram potency ratios of 1:1 to oral morphine and 3:1 to intravenous morphine were used. CONCLUSION Oxycodone has been shown for the first time to be as versatile and flexible as oral morphine in the management of chronic pain in patients with advanced cancer.


2018 ◽  
Vol 4 (3) ◽  
pp. 131 ◽  
Author(s):  
Paul Alexander Sloan, MD ◽  
Robert L. Barkin, PharmD, MBA

The treatment of chronic pain remains an enormous challenge in the United States. Opioid analgesics are an important component of pharmacotherapy for chronic pain and have proven efficacy in the management of cancer and noncancer chronic pain. The newest addition to oral opioid pharmacotherapy is oral oxymorphone, a semisynthetic opioid agonist that is now available in oral immediate-release (IR) and extended-release (ER) formulations. This review discusses the pharmacology, pharmacokinetics, pharmacodynamics, pharmacotherapeutics, and clinical use of oral oxymorphone IR and ER formulations for the management of moderate to severe pain for different types of patients in a variety of settings. Two published studies evaluated the efficacy and safety of oxymorphone IR in patients with moderate to severe postoperative pain and demonstrated that it provides rapid and effective analgesia and is generally well tolerated. Six published randomized controlled trials and three published open-label studies evaluated the efficacy and safety of oxymorphone ER for chronic cancer or noncancer pain. These trials found analgesic efficacy and tolerability comparable to that provided by morphine controlled release (CR) or oxycodone CR; treatment effects with oxymorphone ER were durable for treatment periods of 12 weeks at the same dose or up to 1 year with little dose escalation. Titrated doses of oxymorphone ER were effective and generally well tolerated in both opioid-experienced and opioid-naïve patients. Aspects of oxymorphone metabolism and limited protein binding may simplify treatment in certain populations.


1996 ◽  
Vol 11 (6) ◽  
pp. 320-330 ◽  
Author(s):  
C. Gay ◽  
E. Planas ◽  
M. Donado ◽  
J.M. Martínez ◽  
R. Artigas ◽  
...  

2004 ◽  
Vol 94 (3) ◽  
pp. 305-314 ◽  
Author(s):  
Paul J. Desjardins ◽  
Louise Traylor ◽  
Richard C. Hubbard

The efficacy and safety of preoperative intravenous administration of parecoxib sodium, a novel parenteral prodrug of a cyclooxygenase-2 selective inhibitor, in treating postoperative pain resulting from bunionectomy were evaluated in 50 patients who were part of a larger cohort of orthopedic and podiatric patients. Following bunionectomy, the median time to rescue medication (survival analysis) was 4 hours 18 min (95% confidence interval, 3 hours 4 min to 4 hours 37 min) in the placebo group, 7 hours 5 min (95% confidence interval, 3 hours 20 min to >24 hours) in the 20-mg parecoxib sodium group, and 10 hours 43 min (95% confidence interval, 4 hours 42 min to 14 hours 7 min) in the 40-mg parecoxib sodium group (significant for 40-mg parecoxib sodium versus placebo). Four or more hours after surgery, the mean pain-intensity (categorical) score was significantly lower in both parecoxib sodium groups than in the placebo group. Preoperative administration of parecoxib sodium was well tolerated and significantly reduced postoperative pain in patients who had undergone bunionectomy. (J Am Podiatr Med Assoc 94(3): 305–314, 2004)


1998 ◽  
Vol 38 (2S) ◽  
pp. 11S-18S ◽  
Author(s):  
Stephen A. Cooper ◽  
Donald C. Reynolds ◽  
Beverly Reynolds ◽  
Elliot V. Hersh

2003 ◽  
Vol 99 (3) ◽  
pp. 693-700 ◽  
Author(s):  
John B. Thipphawong ◽  
Najib Babul ◽  
Richard J. Morishige ◽  
Hugh K. Findlay ◽  
Keith R. Reber ◽  
...  

Background The AERx Pain Management System (Aradigm Corporation, Hayward, CA) is a novel pulmonary delivery system for the systemic administration of morphine. The authors compared the relative analgesic efficacy and safety of the AERx Pain Management System with those of placebo and intravenous morphine in an orthopedic postsurgical pain model. Methods Eighty-nine male and female PS-1 to PS-3 patients underwent standardized bunionectomy surgery and received multiple doses of inhaled or intravenous placebo, inhaled morphine (one inhalation [2.2 mg] or three inhalations [6.6 mg]), or intravenous morphine (4 mg) in a blinded fashion. Open-label rescue morphine (2 mg) was also available as needed. Pain intensity, pain relief, and time to pain relief were measured after the first dose. Global evaluation, morphine consumption, vital signs, and adverse events were monitored for 8 h after treatment. Blinded study personnel performed all treatment administrations and pain assessments. Results Three inhalations of morphine and 4 mg intravenous morphine provided comparable single- and multiple-dose analgesia. One inhalation of morphine was statistically indistinguishable from placebo. Three inhalations of morphine and 4 mg intravenous morphine both consistently demonstrated significantly greater analgesic efficacy than did placebo and one inhalation of morphine. Conclusions Comparable analgesic efficacy was demonstrated between a carefully matched dose of inhaled and intravenous morphine in a postsurgical pain model.


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