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NCT00083356 · ClinicalTrials.gov registry record · Phase 2
Bradykinin Receptors and Pain
A Phase 2 study, sponsored by National Institute of Nursing Research (NINR).
- Completed
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
NCT00083356 is a Phase 2 study that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 90 participants.
The verdict
NCT00083356, a Phase 2 study, has completed, sponsored by National Institute of Nursing Research (NINR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
Study Summary
This study will examine whether bradykinin receptors are produced at the site of wisdom tooth extraction and if they contribute to the amount of inflammation and pain that follows surgery. Bradykinin is a molecule produced by enzymes at the site of an injury and then binds to receptors to cause pain. The study will also evaluate the role of genetic factors in the production of bradykinin and their receptors and the pain associated with minor surgical procedures. Patients between 16 and 35 years of age who are referred to the NIH dental clinic for removal of two wisdom teeth may be eligible for this study. Candidates must be in good health and must not be allergic to aspirin, non-steroidal anti-inflammatory drugs, sulfites, or amide anesthetics. They will be screened with a medical history and oral examination, including x-rays to confirm the need for wisdom tooth extraction. On the morning of surgery following an overnight fast, participants have a blood sample drawn to extract DNA for gene studies. Just before surgery, they are given an intravenous (IV) sedative to induce drowsiness and a local anesthetic to numb the mouth. They are also given IV either Ketorolac, a non-steroidal anti-inflammatory drug, or placebo, a look-alike medication with no active ingredient. After the extractions, a small piece of plastic tubing is placed in both extraction sites, and every 20 minutes for the next 3 hours inflammatory fluid is collected from the tubing for measuring chemicals believed to cause pain and swelling. Patients rate their pain by answering pain-related questions every 20 minutes. Patients who have pain that is not relieved by the study medication (Ketorolac or placebo) are given, upon request, 50 mg of the pain reliever tramadol (Ultram). Patients remain in the clinic for at least 3 hours and no more than 7 hours after surgery in order for monitoring the effects of the study drugs as the local anesthetic wears off. Patients undergo two biopsies during the study
Interventions
- PROCEDURE Wisdom tooth extraction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2004-05 |
| Est. Completion | 2006-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00083356
The ClinicalTrials.gov registry entry for NCT00083356 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Wisdom tooth extraction is the first listed.
NCT00083356 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00083356 about?
NCT00083356 is a clinical study titled "Bradykinin Receptors and Pain". This study will examine whether bradykinin receptors are produced at the site of wisdom tooth extraction and if they contribute to the amount of inflammation and pain that follows surgery. Bradykinin is a molecule produced by enzymes at the site of an injury and then binds to receptors to cause pain...
What is the current status of trial NCT00083356?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2004-05. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00083356?
The interventions under investigation include: Wisdom tooth extraction (PROCEDURE).
Who is sponsoring clinical trial NCT00083356?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
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