Pain, Hyperalgesia
Conditions
Keywords
pretreatment, healthy volunteers
Brief summary
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.
Interventions
DRUGvaldecoxib
Sponsors
Pfizer
National Institutes of Health (NIH)
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the area of secondary hyperalgesia | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in pain threshold | — |
| Reduction in pain unpleasantness | — |
Countries
United States
Outcome results
None listed