Evaluation of a TNF-Alpha Modulator for Clinical and Molecular Indicators of Analgesic Effect
Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the role of thalidomide, a tumor necrosis factor (TNF)-alpha
modulator, on severe inflammation and relief of pain following extraction of wisdom teeth.
TNFs are substances that affect the pathways of pain. This study involves an experimental
group in which patients will be given thalidomide or a placebo (an inactive substance); a
negative control group receiving the medication diazepam or a placebo; and a positive control
group receiving diazepam or ibuprofen.
Patients who are males ages 16 to 35, who are not allergic to aspirin or other nonsteroidal
anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics, and who in good
health may be eligible for this study. Females are not eligible, owing to the risks that
thalidomide presents to unborn children. To minimize the risk of fetal malformations, male
patients who participate must use a condom during sexual intercourse for 4 weeks following
the study and must not donate blood for 4 weeks.
The medications used in the study will be given 1 hour before surgery. Then after the wisdom
teeth are removed, a small piece of tubing will be placed into both sides of the patient's
mouth where the teeth were removed. Every 20 minutes, for the next 6 hours, the researchers
will collect inflammatory fluid from the tubing, to measure for changes in anti-inflammatory
action. If they request pain relievers, patients will receive the medication ketorolac
(Toradol), used for short-term treatment of moderately severe acute pain. Side effects of
thalidomide include fatigue, dizziness, and rash. The use of ibuprofen and ketorolac may
include the risk of gastrointestinal ulcers and bleeding. Diazepam can cause involuntary
muscle movements and drowsiness, as well as dizziness lasting for up to 24 hours after it has
been used as sedation. Patients will be instructed not to try to walk alone or to try to
drive a vehicle during that period. Other risks related to participation in this study
include those usually experienced with removal of wisdom teeth-that is, pain and swelling,
bruising from insertion of the sedative into a vein (if needed), possible infection at the
extraction site, prolonged bleeding, and numbness.
Benefits from participating are having wisdom teeth removed at no cost as well as close
monitoring before and after surgery. Results from the study may help people in the future by
improving the management of pain following surgery.