Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001724
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of the Analgesic Effects of Locally Applied Flurbiprofen and Bupivacaine in the Oral Surgery Model
Status:
COMPLETED
Status Verified Date:
2001-11
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 evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen Ansaid Registered Trademark in relieving pain following oral surgery Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain
Patients 16 years of age and older requiring third molar wisdom tooth extraction may be eligible for this study
Patients will undergo oral surgery to remove two lower third molar teeth Before surgery they will be given a local anesthetic lidocaine with epinephrine injected in the mouth and a sedative Versed infused through a catheter thin plastic tube placed in an arm vein At the time of surgery patients will also be given flurbiprofen or a placebo formulation look-alike substance with no active ingredient directly into the extraction site and a capsule that also may contain flurbiprofen or placebo One in seven patients will receive only placebo
All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever A small blood sample will be collected during surgery and at 15 minutes one-half hour and 1 2 3 4 5 6 24 and 48 hours after surgery to measure flurbiprofen blood levels A total of 33 ml about 2 tablespoons of blood will be drawn for these tests Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative the 24- and 48-hour samples will be taken by needle from an arm or hand vein Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery
Patients 16 years of age and older requiring third molar wisdom tooth extraction may be eligible for this study
Patients will undergo oral surgery to remove two lower third molar teeth Before surgery they will be given a local anesthetic lidocaine with epinephrine injected in the mouth and a sedative Versed infused through a catheter thin plastic tube placed in an arm vein At the time of surgery patients will also be given flurbiprofen or a placebo formulation look-alike substance with no active ingredient directly into the extraction site and a capsule that also may contain flurbiprofen or placebo One in seven patients will receive only placebo
All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever A small blood sample will be collected during surgery and at 15 minutes one-half hour and 1 2 3 4 5 6 24 and 48 hours after surgery to measure flurbiprofen blood levels A total of 33 ml about 2 tablespoons of blood will be drawn for these tests Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative the 24- and 48-hour samples will be taken by needle from an arm or hand vein Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery
Detailed Description:
This study proposes to evaluate the analgesic efficacy tissue response and adverse effects of microencapsulated preparations of a nonsteroidal anti-inflammatory drug NSAID and a long-acting local anesthetic administered into post-extraction sites prior to pain onset Subjects N84 will have two mandibular impacted third molars removed and be randomly allocated to receive one of six possible treatments placed into the sockets 0 mg placebo formulation 3125 mg 625 mg 125 mg or 25 mg flurbiprofen or 50 mg bupivacaine Each patient in these six groups N12group will also receive an oral placebo capsule The seventh group of subjects will receive a placebo at the extraction sites and 25 mg of flurbiprofen orally Subjects will remain at the clinic for six hours following drug administration to record every 30 minutes the offset of mandibular anesthesia postoperative pain intensity side effects and for observation of recurrent bleeding Demonstration of a dose-responsive relationship for flurbiprofen at doses lower than needed for analgesia following oral administration will provide the basis for a second study in which an optimal dose of flurbiprofen will be combined with bupivacaine
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 |
|---|---|---|---|
| 98-D-0035 | None | None | None |