Status:
COMPLETED
Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Pain
Eligibility:
All Genders
7-35 years
Phase:
PHASE2
Brief Summary
This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in ge...
Detailed Description
The proposed clinical trial will evaluate the role of genetic factors including single nucleotide polymorphisms from cyclooxygenase (COX) - 2 gene on acute pain after tissue injury and the analgesic e...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Male or female volunteers referred for third molar extraction willing to undergo 2 visits: 1 test and blood withdrawal visit and 1 surgical appointment
- Between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars)
- In general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation)
- Willing to undergo observation period for up to 6 hours postoperatively (3 hours post-surgery and 3 hours post-medication)
- Ability to complete a 100 mm VAS and a category scale every 20 minutes for the observation period (6 hours)
- Willing to have a microdialysis probe placed beneath the surgical flap during the 3 hours post-surgery and 3 hours post-medication
- Willing to have a preoperative and postoperative biopsy at 3 hours after the surgery
- Must have two lower partial (rating = 3) or fully impacted (rating = 4) wisdom teeth (mandibular third molars)
- As assessed at the screening visit, the sum of the mandibular third molar surgical difficulty ratings must be between 6 to 8 in order to evaluate subjects experiencing similar pain levels
- As assessed at the screening visit, subjects must have specific ethnic background of interest to minimize the ethnic effect on pain sensitivity, genotype frequency and haplotype patterns.
- As assessed at the genotyping, subjects must have specific genotype of interest
- EXCLUSION CRITERIA
- Patients who are allergic to aspirin, NSAIDs, sulfites, or amide anesthetics
- Patients who have had asthma, or hives
- Patients who are pregnant or nursing
- Patients with history of peptic ulcers and/or GI bleeding
Exclusion
Key Trial Info
Start Date :
June 20 2005
Trial Type :
INTERVENTIONAL
End Date :
October 4 2006
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00115752
Start Date
June 20 2005
End Date
October 4 2006
Last Update
July 2 2017
Active Locations (1)
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1
National Institute of Nursing Research (NINR)
Bethesda, Maryland, United States, 20892