Articles: analgesics.
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Multicenter Study
Effect of FDA Investigation on Opioid Prescribing to Children After Tonsillectomy/Adenoidectomy.
In August 2012, the Food and Drug Administration investigated the safety of codeine use by children after tonsillectomy and/or adenoidectomy, culminating in a black box warning in February 2013. The objective of this study was to evaluate the association between the investigation and opioid prescribing to children undergoing these surgeries. ⋯ The Food and Drug Administration investigation substantially decreased codeine prescribing to children after tonsillectomy and/or adenoidectomy. However, 1 in 20 children undergoing these surgeries were still prescribed codeine in December 2015 despite its well-documented safety and efficacy issues.
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Randomized Controlled Trial Multicenter Study
The MOBILE Study-A Phase IIa Enriched Enrollment Randomized Withdrawal Trial to Assess the Analgesic Efficacy and Safety of ASP8477, a Fatty Acid Amide Hydrolase Inhibitor, in Patients with Peripheral Neuropathic Pain.
To evaluate the analgesic efficacy and safety of ASP8477 in patients with peripheral neuropathic pain (PNP). ⋯ ASP8477 was well tolerated in patients with PNP; however, ASP8477 did not demonstrate a significant treatment difference compared with placebo.
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Randomized Controlled Trial Multicenter Study
Randomized Phase III and Extension Studies of Naldemedine in Patients With Opioid-Induced Constipation and Cancer.
Purpose Opioid-induced constipation (OIC) is a frequent and debilitating adverse effect (AE) of opioids-common analgesics for cancer pain. We investigated the efficacy and safety of a peripherally acting μ-opioid receptor antagonist, naldemedine (S-297995), for OIC, specifically in patients with cancer. Patients and Methods This phase III trial consisted of a 2-week, randomized, double-blind, placebo-controlled study (COMPOSE-4) and an open-label, 12-week extension study (COMPOSE-5). ⋯ Diarrhea was the most frequently reported TEAE in COMPOSE-4 (19.6% [19 of 97 patients] v 7.3% [seven of 96 patients] with naldemedine v placebo) and COMPOSE-5 (18.3% [24 of 131 patients] with naldemedine). Naldemedine was not associated with signs or symptoms of opioid withdrawal and had no notable impact on opioid-mediated analgesia. Conclusion Once-daily oral naldemedine 0.2 mg effectively treated OIC and was generally well tolerated in patients with OIC and cancer.
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Multicenter Study
The Critical Care Crisis of Opioid Overdoses in the United States.
Opioid abuse is increasing, but its impact on critical care resources in the United States is unknown. ⋯ The number of deaths of ICU patients with opioid overdoses increased substantially in the 7 years of our study, reflecting increases in both the incidence and mortality of this condition. Our findings raise the need for a national approach to developing safe strategies to care for patients with overdose in the ICU, to providing coordinated resources in the hospital for patients and families, and to helping survivors maintain sobriety on discharge.
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Multicenter Study Observational Study
Multicenter, Prospective Study of Prehospital Administration of Analgesia in the U.S. Combat Theater of Afghanistan.
Published data on prehospital medical care in combat is limited, likely due to the chaotic and unpredictable nature of care under fire and difficulty in documentation There is limited data on how often analgesic agents are administered, which drug are being used, and whether there is an association with injury patterns. ⋯ Patients with penetrating trauma are more likely to receive analgesic agents in the combat prehospital setting. The most common analgesic used was ketamine. Patient ISS was not associated with administration of analgesia. Patients receiving analgesia were more likely to still be hospitalized at 30 days. The prospective nature of this study supports feasibility for future, larger, more comprehensive projects.