Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083356
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-05-21
Brief Title:
Bradykinin Receptors and Pain
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Bradykinin-1 Receptor and Kinin Induction in a Clinical Model of Tissue Injury
Status:
COMPLETED
Status Verified Date:
2006-02
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 examine whether bradykinin receptors are produced at the site of wisdom tooth extraction and if they contribute to the amount of inflammation and pain that follows surgery Bradykinin is a molecule produced by enzymes at the site of an injury and then binds to receptors to cause pain The study will also evaluate the role of genetic factors in the production of bradykinin and their receptors and the pain associated with minor surgical procedures
Patients between 16 and 35 years of age who are referred to the NIH dental clinic for removal of two wisdom teeth may be eligible for this study Candidates must be in good health and must not be allergic to aspirin non-steroidal anti-inflammatory drugs sulfites or amide anesthetics They will be screened with a medical history and oral examination including x-rays to confirm the need for wisdom tooth extraction
On the morning of surgery following an overnight fast participants have a blood sample drawn to extract DNA for gene studies Just before surgery they are given an intravenous IV sedative to induce drowsiness and a local anesthetic to numb the mouth They are also given IV either Ketorolac a non-steroidal anti-inflammatory drug or placebo a look-alike medication with no active ingredient After the extractions a small piece of plastic tubing is placed in both extraction sites and every 20 minutes for the next 3 hours inflammatory fluid is collected from the tubing for measuring chemicals believed to cause pain and swelling Patients rate their pain by answering pain-related questions every 20 minutes Patients who have pain that is not relieved by the study medication Ketorolac or placebo are given upon request 50 mg of the pain reliever tramadol Ultram Patients remain in the clinic for at least 3 hours and no more than 7 hours after surgery in order for monitoring the effects of the study drugs as the local anesthetic wears off
Patients undergo two biopsies during the study - one before and one after the extraction - to measure any changes in chemicals produced in response to the surgery The second biopsy is done either 3 7 or 24 hours after the extraction Patients in the 3- and 7-hour groups are given a small dose of local anesthetic in the gum for the second biopsy and remain in the clinic until the biopsy is done those in the 24-hour group are given forms to record pain ratings at home and return to the clinic the following morning for a 2-hour follow-up visit All patients are given standard pain medication flurbiprofen to take at home
Patients between 16 and 35 years of age who are referred to the NIH dental clinic for removal of two wisdom teeth may be eligible for this study Candidates must be in good health and must not be allergic to aspirin non-steroidal anti-inflammatory drugs sulfites or amide anesthetics They will be screened with a medical history and oral examination including x-rays to confirm the need for wisdom tooth extraction
On the morning of surgery following an overnight fast participants have a blood sample drawn to extract DNA for gene studies Just before surgery they are given an intravenous IV sedative to induce drowsiness and a local anesthetic to numb the mouth They are also given IV either Ketorolac a non-steroidal anti-inflammatory drug or placebo a look-alike medication with no active ingredient After the extractions a small piece of plastic tubing is placed in both extraction sites and every 20 minutes for the next 3 hours inflammatory fluid is collected from the tubing for measuring chemicals believed to cause pain and swelling Patients rate their pain by answering pain-related questions every 20 minutes Patients who have pain that is not relieved by the study medication Ketorolac or placebo are given upon request 50 mg of the pain reliever tramadol Ultram Patients remain in the clinic for at least 3 hours and no more than 7 hours after surgery in order for monitoring the effects of the study drugs as the local anesthetic wears off
Patients undergo two biopsies during the study - one before and one after the extraction - to measure any changes in chemicals produced in response to the surgery The second biopsy is done either 3 7 or 24 hours after the extraction Patients in the 3- and 7-hour groups are given a small dose of local anesthetic in the gum for the second biopsy and remain in the clinic until the biopsy is done those in the 24-hour group are given forms to record pain ratings at home and return to the clinic the following morning for a 2-hour follow-up visit All patients are given standard pain medication flurbiprofen to take at home
Detailed Description:
Bradykinin B1 receptors and their natural agonists are known to be rapidly induced in local tissues by a variety of inflammatory stimuli Preclinical evidence demonstrating that interruption of B1 receptor function causes analgesia under a variety of conditions has been well established using selective antagonists and genetically modified mice Accordingly efforts are underway in several laboratories to develop novel B1 receptor antagonists as potential novel analgesic agents The proposed studies will examine the kinetics of local induction of B1 receptors and kinin formation in a common situation of acute inflammatory pain in humans - tooth extraction In addition an examination of expression of additional genes of interest under these conditions using microarray analysis will be conducted
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-NR-0182 | None | None | None |