Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers

Penn State University20 enrolled

Overview

Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Pain Hyperalgesia

Interventions

valdecoxibDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male of non-pregnant female; 18yo or older * not currently taking NSAID * able and willing to provide informed consent * willing to avoid other NSAIDs in 24 hour period following study * no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin Exclusion Criteria: * pregnant or breast feeding * use of NSAIDS or other analgesic medications in past 7 days * unwilling or unable to give informed consent * contraindication to any study medication or other NSAID

Locations (1)

Penn State University College of Medicine

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Reduction in the area of secondary hyperalgesia

Secondary Outcomes

Reduction in pain threshold

Reduction in pain unpleasantness

Data from ClinicalTrials.gov

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