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Influence of Genetics in Pain Sensitivity

NCT00001956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2006-06-30

No results posted yet for this study

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.

Conditions

  • Healthy
  • Hyperalgesia
  • Pain

Interventions

PROCEDURE

Blood draw

PROCEDURE

Oral surgery

PROCEDURE

Tissue biopsy

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-01-31
Completion
2005-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001956 on ClinicalTrials.gov