Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008476
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-01-09
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:
2004-01
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:
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
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
Detailed Description:
Successful preemptive analgesia strategies are superior to traditional pain management schemes in the management of post-operative pain However agents with appropriate pharmacokinetic properties are not readily available 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 will be given an intramucosal injection of either capsaicin or placebo Or as a positive control 24 hours later intravenous Toradol Subjects will have one lower impacted wisdom tooth extracted under local anesthesia and then will rate their pain The time of analgesic rescue medication request will be noted 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 a 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 |
|---|---|---|---|
| 01-D-0056 | None | None | None |