NIH Clinical Research Studies

Protocol Number: 00-D-0055

Active Accrual, Protocols Recruiting New Patients

Title:
Genetics of Pain
Number:
00-D-0055
Summary:
The purpose of this study is to learn more about the role of genetics in pain sensitivity. Pain perception varies widely among individuals, and information gained from this trial may lead to better methods of preventing and controlling pain. The study consists of two parts, described below. All enrollees will participate in part 1; patients needing oral surgery for removal of third molars may also participate in part 2.

Normal volunteers, oral surgery patients, and family members of both groups may be eligible for this study.

Part 1 -Sensitivity testing for hot and cold. Participants will rate their pain response to hot and cold stimuli on a scale from "no pain" to the "worst pain imaginable." Heat sensitivity is measured using a small probe placed on the skin for a few seconds. The hottest temperature tested may cause pain for a few seconds but will not produce a burn. Response to cold is measured by placing the hand in cold water for up to 3 minutes and occasionally flexing the fist. Participants will rate their pain level every 15 seconds. In addition to the testing, a blood sample will be drawn to examine for genes related to pain.

Part 2 - Oral surgery. Patients will have their third molar removed under a local anesthetic (lidocaine) injected in the mouth and a sedative (Versed) given through a vein in the arm. A small tissue biopsy will be taken from the tissue over one of the third molars. Patients will stay in the clinic for up to 7 hours after surgery while the anesthetic wears off and will rate any pain they may have according to the rating scale used in Part 1 of the study. Pain medication (ketorolac, or Toradol) will be given when needed, and patients will complete pain questionnaires for 3 hours after the drug is given to rate its effectiveness. Patients will receive additional pain relievers, if needed. A second biopsy on the side opposite the first will be taken under local anesthetic to measure changes in chemical signals produced in response to the surgery.

Sponsoring Institute:
National Institute of Dental And Craniofacial Research (NIDCR)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Patients in need of oral surgery for removal of impacted third molar will be recruited from the local community and by physician or dental referrals.

EXCLUSION CRITERIA:

Use of prescription and nonprescription analgesics, antihistamines, and antidepressants. No history of psychiatric or neurological disorders or a positive score on the Beck Depression Inventory, those females who are pregnant or nursing.

Special Instructions:
Healthy Volunteers currently are not being recruited for this protocol.
Keywords:
Genetic Markers
Thermal Pain
Hyperalgesia
Oral Surgery
Cold Pain
Peripheral Nerve
Allodynia
Spinal Cord
Personality Traits
Pain Ratings
Recruitment Keywords:
None
Conditions:
Healthy
Hyperalgesia
Pain
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Measurements of human pressure-pain thresholds on fingers and toes

Positron emission tomographic analysis of cerebral structures activated specifically by repetitive noxious heat stimuli

Human pain responsivity in a tonic pain model: psychological determinants

Active Accrual, Protocols Recruiting New Patients

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