Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventional Hydrocodone 7.5 mg/Acetaminophen 325 mg.

Autor:	Zuniga JR; Department of Surgery and Division of Oral and Maxillofacial Surgery, University of Texas Southwestern Medical Center, Dallas, Texas., Papas AS; Department of Diagnostic Sciences, Tufts School of Dental Medicine, Boston, Massachusetts., Daniels SE; Optimal Research, LLC, Austin, Texas.; Formerly with Premier Research Group, LLC, Durham, North Carolina., Patrick K; PRA Health Sciences, San Diego, California., Muse DD; Jean Brown Research, Inc., Salt Lake City, Utah., Oreadi D; Department of Oral and Maxillofacial Surgery, Tufts School of Dental Medicine, Boston, Massachusetts., Giannakopoulos HE; Department of Oral and Maxillofacial Surgery, Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania., Granquist EJ; Department of Oral and Maxillofacial Surgery, Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania., Levin LM; Department of Oral and Maxillofacial Surgery, University of Pennsylvania, Philadelphia, Pennsylvania., Chou JC; Department of Oral and Maxillofacial Surgery, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania., Maibach H; IndigoRDD, LLC, Bethesda, Maryland., Schachtel BP; Olas Pharma, Inc. (wholly owned subsidiary of Charleston Laboratories, Inc.), Jupiter, Florida, USA.
Jazyk:	angličtina
Zdroj:	Pain medicine (Malden, Mass.) [Pain Med] 2019 Dec 01; Vol. 20 (12), pp. 2528-2538.
DOI:	10.1093/pm/pny294
Abstrakt:	Objectives: To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12.5 mg) with hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP) was used. Methods: This was a multicenter, randomized, double-blind, placebo- and active-controlled multidose study. After surgical extraction of two or more impacted third molar teeth (including at least one mandibular impaction), 466 patients with moderate to severe pain (measured on a categorical pain intensity scale [PI-CAT]) were randomized to CL-108, HC/APAP, or placebo. Over the next 24 hours, patients used the PI-CAT to assess pain at regular intervals whereas nausea, vomiting, and other opioid-related side effects were also assessed prospectively. Study medications were taken every four to six hours as needed; supplemental rescue analgesic and antiemetic medications were permitted. Co-primary end points were the incidence of OINV and the time-weighted sum of pain intensity differences over 24 hours (SPID24). Results: Relative to HC/APAP treatment alone, CL-108 treatment reduced OINV by 64% (P < 0.001). Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P < 0.001). There were no unexpected or serious adverse events. Conclusions: CL-108 is a safe and effective combination analgesic/antiemetic for the prevention of OINV during treatment of moderate to severe acute pain. (© 2019 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu