Post op Pain Clinical Trial
Official title:
Phenotyping Acute Pain for Discovery Research and Directed Therapeutics
The goal of the current study is to combine existing and new tools for quantifying patient self-report to characterize changes in acute pain. The ability to quantitatively measure self-report provides behavioral pain phenotypes that can serve as the basis for clustering patients into sub-groups based on their self-report of their symptoms, eliminating observer based perceptions of patients' pain.
Pain is a therapeutic challenge as well as a public health problem that is estimated to
affect over 116 million American adults [1]; reduces quality of life; and is estimated to
cost up to $635 billion annually. Growing recognition of the need for evidence-based,
individual-centered treatment strategies raises expectations that health care will be
improved by matching proven effective treatments with knowledge of patients' unique
characteristics to optimize efficacy and safety. Essential to the goal of matching treatments
to patients to enhance analgesic drug development and therapy is identification of
intermediate phenotypes that capture the mechanistic complexity, genetic expression and
epigenetic changes of hundreds of ongoing processes and mediators that influence treatment
efficacy and safety and may form the basis for differential responses to drug therapy. The
ability to identify functional variants in the genomic responses to pain and therapeutics at
the sub-group and patient levels, however, has been limited to date by lack of thorough
phenotyping for patients with pain.
The need for a more comprehensive understanding of human phenotypes has spawned a new method
of phenotyping studies referred to as "deep phenotyping." Deep phenotyping for
pharmacogenomic studies requires both breath and depth to better interpret the complexities
of genomic variations that may underlie individual differences in pain report. One approach
to address this complexity is to use quantitative testing of clinical features to identify
more homogeneous subsets within a group of patients with a given diagnosis or characteristic.
Variations in quantitative measures may identify intermediate phenotypes that are genetically
less complex yet have potentially stronger signals closer to the site of gene action. In
pain, quantitative testing is often termed "quantitative sensory testing", or QST.
Exclusion
1. Current or history of mental disorder or substance abuse
2. Allergy to aspirin, NSAIDS, or sulfonamide
3. Pregnant and/or nursing
4. History of peptic ulcers and/or GI bleeding
5. Concurrent use of agents which may obscure pain report, e.g., alcohol, opioids,
benzodiazepines, and depressants, etc
6. Chronic use of medications confounding assessment of the inflammatory response or
analgesia, e.g., antihistamines, NSAIDS, steroids, antidepressants
7. Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver
disease, cancer, hypertension or obesity (body mass index >35)
8. Expectation of excessive surgical difficulty, resulting in a difficulty score of 5 for
any tooth (determined from panoramic radiograph)
9. Subjects with extreme anxiety and who are candidates for general anesthesia or conscious
sedation
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