CLINICAL TRIALS PROFILE FOR TORADOL
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All Clinical Trials for TORADOL
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00006070 ↗ | Etanercept (Enbrel) to Treat Pain and Swelling After Third Molar Extraction | Completed | National Institute of Dental and Craniofacial Research (NIDCR) | Phase 2 | 2000-07-01 | This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on relieving pain and swelling after oral surgery. The Food and Drug Administration has approved Enbrel for treating symptoms of rheumatoid arthritis, including pain. Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions may be eligible for this study. Participants must not be allergic to aspirin or to non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility with a medical history and oral examination, including X-rays if needed. Participation in the study requires four clinic visits: two for surgery and two for follow-up: Visit 1: Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery, they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes effect, a small piece of tissue will be removed from the inside of the cheek, and then the upper and lower molars on one side of the mouth will be extracted. After surgery, a small piece of tubing will be placed in the lower extraction site, from which samples will be collected to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for 4 hours after surgery while the anesthetic wears off and will complete pain questionnaires during that time. If, an hour after surgery, patients have pain that is not relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then will be removed and the patient discharged with Tylenol and codeine for pain. Visit 2: Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to 2-hour visit. They will fill out questionnaires, undergo ultrasound imaging of both cheeks and have another biopsy taken from the inside of the cheek on the operated side. Visits 3 and 4: Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth on the other side of the mouth, and the procedures for visits 1 and 2 will be repeated. |
| NCT00008476 ↗ | Capsaicin to Control Pain Following Third Molar Extraction | Completed | National Institute of Dental and Craniofacial Research (NIDCR) | Phase 2 | 2001-01-01 | This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants will undergo the following procedures in three visits: Visit 1: Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor applied to the gums and the patient will rate when they first feel heat and when the heat feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums, and the patient will say whether it feels painful; 3) a light touch will be applied to the gums with a small needle, and the patient will rate the pain intensity following the touch. After testing, patients will be numbed with a local anesthetic (bupivacaine) and then capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth then will be extracted one day later. Visit 2: Patients will return to the clinic after 24 hours to repeat the same type of sensory testing. After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and given an intravenous injection of either saline or ketorolac (30 mg). After the extraction, pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients will be monitored for numbness, pain, side effects and vital signs (heart rate, blood pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and codeine. Patients will be required to stay for up to 3 more hours after this and then they will then be discharged with pain medicine. Visit 3: Patients will return to the clinic after another 48 hours to repeat the same sensory testing. Remaining wisdom teeth will be removed "off-study" at least three weeks following the first visit. |
| NCT00088686 ↗ | Capsaicin to Control Pain Following Third Molar Extraction | Completed | National Institute of Dental and Craniofacial Research (NIDCR) | Phase 2 | 2004-07-01 | Capsaicin to Control Pain Following Third Molar Extraction Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits: Visit 1 Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth. Visit 2 Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effects. Patients who request pain-relief medication are given acetaminophen and codeine. At the end of the study, they are discharged from the clinic and given acetaminophen and codeine to take at home, as instructed. They are provided a pain diary to record pain ratings and any adverse reactions that might occur until the last visit. Visit 3 Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining wisdom teeth are removed "off-study" no sooner than 1 week following the first visit. |
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