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Volume 11, Issue 1, Pages 24-31 (January 2010)


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A Multicenter, Open-Label, Exploratory Dose-Ranging Trial of Intranasal Hydromorphone for Managing Acute Pain from Traumatic Injury

Daniel P. WermelingCorresponding Author Informationemail address, Thomas Clinch, Anita C. Rudy, David Dreitlein, Selim Suner§, Peter G. Lacouture

Received 5 February 2009; received in revised form 23 April 2009; accepted 22 May 2009. published online 10 July 2009.

Abstract 

We conducted a prospective multicenter, open-label, escalating dose-range trial to compare, across patients, single intranasal doses (2, 4, 6, 8, and 10 mg) of hydromorphone HCl in the treatment of acute trauma pain The main outcome measure of pain-intensity reduction was derived from serial Numerical Pain-Rating Scores and calculated as the summed pain-intensity difference over 3 hours (SPID 3). Nasal examinations, vital signs, and adverse events were reported as safety outcomes. The mean decrease in pain intensity from baseline to 30 minutes was 39 to 44% for the 4-, 6-, 8- and 10-mg doses (n = 19, 33, 28, and 19 per group) and only 24% reduction for the 2-mg dose (n = 14). SPID 3 for the 2-mg dose was 40 to 50% below all other doses. There were no clinically meaningful changes in vital signs or nasal examinations. Adverse events (nausea, vomiting, pruritis, oxygen desaturation, bad taste, dizziness) were of mild to moderate intensity, increased with dose, and expected, based on route of administration and opioid pharmacology. Intranasal hydromorphone provides a component of rapid pain relief in the care of emergency department patients suffering from acute trauma pain.

Perspective

This article presents a pilot dose-ranging study of intranasally administered hydromorphone, administered in the emergency department to patients suffering from acute trauma pain. This study demonstrates research success in this setting and noninjection-based delivery and certain doses of intranasal hydromorphone may be effective in treating acute trauma pain.

 Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky College of Pharmacy, Lexington, Kentucky

 Intranasal Therapeutics, Inc., Lexington, Kentucky

 Department of Emergency Medicine, Montrose Memorial Hospital, Montrose, Colorado

§ Associate Professor of Emergency Medicine, Surgery, and Engineering, Brown University, Providence, Rhode Island

 Director of Emergency Preparedness and Disaster Medicine, Department of Emergency Medicine, Rhode Island Hospital, Providence, Rhode Island

 Magidom Discovery, Tampa, Florida

Corresponding Author InformationAddress reprint requests to Dr. Daniel Wermeling, Associate Professor, University of Kentucky College of Pharmacy, 725 Rose Street, Lexington, KY 40536-0082.

 The multicenter study was supported by grants from Intranasal Therapeutics, Inc. The following information is provided as a statement of potential conflicts of interest. Drs. Wermeling and Lacouture were paid consultants to Intranasal Therapeutics, Inc., at the time of this research. Drs. Wermeling and Rudy and Mr. Clinch own stock options in Intranasal Therapeutics. Drs. Lacouture, Dreitlein and Suner have no conflicts to disclose.

PII: S1526-5900(09)00547-1

doi:10.1016/j.jpain.2009.05.002


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