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Transbuccal fentanyl for rapid relief of orthopedic pain in the ED☆☆

Melissa L. Sheara, Jonathan N. Adler, MDa, Sanjay Shewakramani, MDa, Jon Ilgen, MDa, Olanrewaju A. Soremekun, MDa, Sara Nelson, MDa, Stephen H. Thomas, MDbCorresponding Author Informationemail address

Received 9 February 2009; received in revised form 11 April 2009; accepted 14 April 2009. published online 10 March 2010.
Corrected Proof

Abstract 

Objectives

This study's objectives were to assess administration of a rapidly dissolving transbuccal fentanyl tablet to patients in emergency department (ED) with orthopedic extremity pain. The main end point was time required to achieve a 2-point drop on a 0 to 10 pain scale.

Methods

In this double-blind trial, subjects received either transbuccal fentanyl, 100 μg, and a swallowed placebo, or a swallowed oxycodone/acetaminophen, 5/325-mg pill, and a nonanalgesic transbuccal comparator. Pain assessment occurred every 5 minutes for an hour, and vital signs were monitored for 2 hours.

Results

Transbuccal fentanyl was associated with faster pain relief onset (median, 10 vs 35 minutes; P < .0001). Secondary end points (pain relief magnitude, rescue medication rate, subject preference for medication on future visit) favored transbuccal fentanyl. No vital sign abnormalities or significant side effects occurred in the ED or on 100% next-day follow-up.

Conclusions

Transbuccal fentanyl shows promise for continued investigation as a means to safely provide rapid and effective pain relief for ED patients.

a Massachusetts General Hospital Emergency Services and Harvard Medical School, Boston, MA 02114, USA

b Department of Emergency Medicine, OU Schusterman Center, University of Oklahoma School of Community Medicine, Tulsa, OK 74135, USA

Corresponding Author InformationCorresponding author. Tel.: +1 918 660 3822; fax: +1 918 660 3821.

 Unrestricted grant from the Harvard Medical School Division of Emergency Medicine.

☆☆ Trial registration: ClinicalTrials.gov, NCT00685295.

PII: S0735-6757(09)00195-8

doi:10.1016/j.ajem.2009.04.011

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