Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088686
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-07-30
Brief Title:
Capsaicin to Control Pain Following Third Molar Extraction
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Vanilloid Receptor Inactivation for Preemptive Analgesia
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients 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
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 patients 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
Detailed Description:
Successful preemptive analgesic strategies are superior to traditional pain management schemes in the management of post-operative pain The premise of this double-blind placebo and positive-controlled clinical study is to evaluate the efficacy of vanilloid agonists as preemptive agents in an oral surgery tissue injury model Vanilloids are a class of small organic compounds the most familiar of which is capsaicin the active ingredient in hot pepper Binding of capsaicin to the vanilloid-1 receptor produces initial activation and then long-acting desensitization of pain specific neurons We propose to produce a selective long-term inactivation of peripheral pain transmission through the local application of capsaicin in the oral mucosa in an effort to prevent or reduce post-operative pain in the oral surgery model Healthy subjects will be recruited and following local anesthesia and conscious sedation will be given an intramucosal injection of either capsaicin or placebo or as a positive control intravenous ketorolac Subjects will rate pain and time of analgesic rescue medication request will be noted Small biopsies will be removed from the extraction site prior to drug injection and at 48 hr post-operatively Tissue levels of neurogenic inflammatory mediators and sensory neuron content will be compared pre- and post-operatively A decrease in post-operative pain and decrease in analgesic use will be taken as a positive effect of the vanilloid for decreasing post-operative pain We anticipate that through the long term blockade of pain specific fibers pre-operatively that there will be significant attenuation of post-operative pain development following surgery This has significant implications for reducing pain and suffering decreasing analgesic use and reducing post-operative complications following surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-D-0248 | None | None | None |