Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026819
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-11-14
Brief Title:
Rofecoxib to Prevent Pain After Third Molar Wisdom Tooth Extraction
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pre-Emptive Analgesic Effects of a Selective COX-2 Inhibitor Rofecoxib in the Oral Surgery Model
Status:
COMPLETED
Status Verified Date:
2003-11
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 ability of a new non-steroidal anti-inflammatory drug NSAID called rofecoxib to prevent pain following third molar wisdom tooth extraction The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis menstrual cramps and pain
Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar wisdom tooth extraction may be eligible for this study Candidates will be screened with a medical history and oral examination including dental x-rays as needed to confirm the need for third molar removal
Participants will have all four wisdom teeth extracted and a biopsy removal of a small piece of tissue will be taken from the inside of the cheek around the area behind the lower wisdom tooth On the morning of surgery patients will be given a dose of either the standard anti-inflammatory drug ibuprofen Advil Nuprin Motrin or rofecoxib or a placebo a pill with no active ingredient Before surgery they will be given a local anesthetic lidocaine in the mouth and a sedative midazolam through an arm vein
After the surgery patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug Patients will complete pain questionnaires Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously through a vein After 4 hours patients will be discharged with additional pain medicines Tylenol with codeine and the study drug and instructions for their use They will also be given a pain diary to record pain ratings and medications taken at home A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed
Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers At this visit another biopsy will be taken under local anesthetic
Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar wisdom tooth extraction may be eligible for this study Candidates will be screened with a medical history and oral examination including dental x-rays as needed to confirm the need for third molar removal
Participants will have all four wisdom teeth extracted and a biopsy removal of a small piece of tissue will be taken from the inside of the cheek around the area behind the lower wisdom tooth On the morning of surgery patients will be given a dose of either the standard anti-inflammatory drug ibuprofen Advil Nuprin Motrin or rofecoxib or a placebo a pill with no active ingredient Before surgery they will be given a local anesthetic lidocaine in the mouth and a sedative midazolam through an arm vein
After the surgery patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug Patients will complete pain questionnaires Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously through a vein After 4 hours patients will be discharged with additional pain medicines Tylenol with codeine and the study drug and instructions for their use They will also be given a pain diary to record pain ratings and medications taken at home A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed
Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers At this visit another biopsy will be taken under local anesthetic
Detailed Description:
Pain and inflammation are predictable sequelae following tissue injury such as surgery Conventional treatment for intraoperative and postoperative control of pain includes local anesthetic administered preoperatively and analgesics administered postoperatively Disadvantages of these approaches include pain during the interval when the effect of local anesthesia dissipates and the postoperatively administered analgesic takes effect and adverse effects of opioid-containing analgesics in ambulatory patients Research over the past two decades has demonstrated that administering nonsteroidal anti-inflammatory drugs NSAIDs preoperatively significantly reduces the intensity and the duration of postoperative pain up to eight hours Dionne et al 1978 and Jackson et al 1989 Parallel clinical investigations suggest that the pre-emptive treatment with a long-acting local anesthetic or an NMDA-antagonist reduces pain at 24 to 72 hours post-surgery Gordon et al 1997 Yamamoto et al 1993 Gordon et al 1999 This proposed clinical trial will use the oral surgery model to assess the therapeutic efficacy of pre-emptive and preventive treatment with a potent selective COX-2 inhibitor rofecoxib Vioxx Registered Trademark given prior to and following third molar extractions to reduce postoperative pain at 24 and 48 hours post-surgery
This study is a double-blind randomized control trial with parallel groups using placebo ibuprofen or rofecoxib Rofecoxib 50 mg will be administered PO 90 minutes before surgery in the Clinical Center at NIH and another 50 mg will be self-administered 24 hours later by the subjects at their homes This regimen is predicted to suppress the onset and intensity of post-operative dental pain to a greater extent than placebo or a non-selective COX-1COX-2 inhibitor ibuprofen The analgesic effect of the drugs will be estimated by hourly observations over the first four hours after surgery using two different measures of pain intensity the category scale and a visual analog scale VAS It is hypothesized that the pre-emptive administration of a selective COX-2 inhibitor rofecoxib will inhibit the development of central and peripheral sensitization following tissue injury which manifests as hyperalgesia at later time points
This study is a double-blind randomized control trial with parallel groups using placebo ibuprofen or rofecoxib Rofecoxib 50 mg will be administered PO 90 minutes before surgery in the Clinical Center at NIH and another 50 mg will be self-administered 24 hours later by the subjects at their homes This regimen is predicted to suppress the onset and intensity of post-operative dental pain to a greater extent than placebo or a non-selective COX-1COX-2 inhibitor ibuprofen The analgesic effect of the drugs will be estimated by hourly observations over the first four hours after surgery using two different measures of pain intensity the category scale and a visual analog scale VAS It is hypothesized that the pre-emptive administration of a selective COX-2 inhibitor rofecoxib will inhibit the development of central and peripheral sensitization following tissue injury which manifests as hyperalgesia at later time points
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 |
|---|---|---|---|
| 02-D-0046 | None | None | None |