Articles: opioid.
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Randomized Controlled Trial Multicenter Study
Efficacy of naloxone in reducing postictal central respiratory dysfunction in patients with epilepsy: study protocol for a double-blind, randomized, placebo-controlled trial.
Generalized tonic-clonic seizures (GTCSs) are the main risk factor for sudden unexpected death in epilepsy (SUDEP). Experimental and clinical data strongly suggest that the majority of SUDEP results from a postictal respiratory dysfunction progressing to terminal apnea. Postictal apnea could partly derive from a seizure-induced massive release of endogenous opioids. The main objective of this study is to evaluate the efficacy of an opioid antagonist, naloxone, administered in the immediate aftermath of a GTCS, in reducing the severity of the postictal central respiratory dysfunction. ⋯ The demonstration of naloxone's efficacy on the severity of postictal hypoxemia will have two primary consequences. First, naloxone would be the first and only therapeutic approach that could be delivered immediately to reverse postictal apnea. Second, demonstration that an opioid antagonist can effectively reduce postictal apnea would pave the way for an assessment of a preventive therapy for SUDEP targeting the same pathophysiological pathway using oral administration of naltrexone.
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Randomized Controlled Trial
Impact of time interval between remifentanil and propofol on propofol injection pain.
To determine the most effective time interval between remifentanil and propofol (TimeRP) for the prevention of propofol injection pain in association with remifentanil dosage. ⋯ The efficacy of remifentanil pretreatment for preventing propofol injection pain can be influenced by the time interval between remifentanil and propofol as well as the remifentanil dose.
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Randomized Controlled Trial Multicenter Study
Efficacy and Tolerability of Buccal Buprenorphine in Opioid-Experienced Patients With Moderate to Severe Chronic Low Back Pain: Results of a Phase 3, Enriched Enrollment, Randomized Withdrawal Study.
A buccal film of buprenorphine (BBUP) was evaluated for safety and efficacy in a multicenter, double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal study in opioid-experienced patients (30 to ≤160 mg/d morphine sulfate equivalent) with moderate to severe chronic low back pain taking around-the-clock opioid analgesics. Patients' opioid doses were tapered to ≤30 mg morphine sulfate equivalent before open-label titration with BBUP (range, 150-900 μg every 12 hours). Patients who responded (received adequate analgesia that was generally well tolerated for 14 days) were randomized to receive buprenorphine (n = 254) or placebo (n = 257) buccal film. ⋯ A significantly larger percentage of patients receiving BBUP than placebo had pain reductions ≥30% and ≥50% (P < 0.001 for both). In the double-blind portion of the study, the only adverse event reported more frequently with BBUP than placebo and in ≥5% of patients was vomiting (5.5% vs 2.3%). These findings demonstrate the efficacy and tolerability of BBUP in opioid-experienced patients taking around-the-clock opioid treatment for chronic low back pain.
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Randomized Controlled Trial Multicenter Study
Efficacy and Safety of Radium-223 Dichloride in Symptomatic Castration-resistant Prostate Cancer Patients With or Without Baseline Opioid Use From the Phase 3 ALSYMPCA Trial.
The phase 3 ALSYMPCA trial enrolled metastatic castration-resistant prostate cancer patients with or without baseline opioid use. ⋯ In this ALSYMPCA opioid subgroup analysis, baseline symptom levels did not appear to impact radium-223 dichloride efficacy or safety.
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Randomized Controlled Trial
Comparison of naproxen with cyclobenzaprine, oxycodone-acetaminophen, and placebo for the treatment of acute low back pain.
Clinical Question Does the addition of cyclobenzaprine or oxycodone with acetaminophen to naproxen result in improved functional outcomes at one week when compared to placebo in patients with acute low back pain? Article Chosen Friedman B, Dym A, Davitt, M, et al. Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain: a randomized clinical trial. JAMA 2015:20;314(15):1572-80. Study Objective The primary objective of this study was to compare functional outcomes at one week and three months after emergency department (ED) presentation for acute low back pain among patients prescribed naproxen plus one of the following: (1) oxycodone/acetaminophen; (2) cyclobenzaprine; or (3) placebo.