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| ID | Type | Description | Link |
|---|---|---|---|
| 112101 668916 | Other Identifier | East Carolina University |
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Narcotics are widely used as the mainstay of pain treatment, although increasing doses are required over time as the individual becomes tolerant to their effects. This can lead to the development of dependence and abuse of these drugs. Research has identified a new way to decrease the risk of developing tolerance to narcotics, by giving at the same time a drug called rotigotine ("Neupro"). Rotigotine interferes with the body's chemical dopamine and is FDA-approved for the management of Parkinson's Disease.
The purpose of this research study is to look at side effects and pain control in healthy people after removal of wisdom teeth, which usually causes pain. It is thought that by giving the study drug rotigotine with the narcotic pain reliever, there will be pain control that will extend longer than when giving the narcotic alone.
Inclusion Criteria:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo patch | Placebo Comparator | Neupro® transdermal patch/placebo randomly allocated like a flip of a coin applied to your skin at the dose of 8 mg/day or a matching placebo patch after the oral surgery procedure is completed. |
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| Neupro® transdermal patch | Experimental | Neupro® transdermal patch/placebo randomly allocated like a flip of a coin applied to your skin at the dose of 8 mg/day or a matching placebo patch after the oral surgery procedure is completed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neupro® transdermal patch/placebo | Drug | 8mg transdermal patch Neupro® transdermal patch/placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Sum of pain intensity difference scores | The primary outcome measure will be the SPID (sum of pain intensity difference scores) over the 3-hour observation period for MS(morphine sulfate)+Nuepro versus MS. | up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic tablets taken postoperatively | The number of analgesic tablets taken over the first 48 hours postoperatively will be compared between the two groups as a secondary measure of the ability of the D3 agonist to potentiate opioid analgesia as a surrogate indicator of reduced potential for tolerance development. | December 2014 |
| Measure | Description | Time Frame |
|---|---|---|
| assess pain | assess the translational potential of what has been demonstrated in the lab to human subjects experiencing painful conditions that require control with morphine. We hope to provide proof of concept for a treatment strategy that will allow opiates to maintain their effectiveness at low doses without the emergence of tolerance and other side effects, even with prolonged use. | up 48 hours |
Inclusion Criteria:
• Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars
Exclusion Criteria:
History or intolerance to rotigotine
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Dionne, DDS, PhD | School of Dental Medicine, East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dental Medicine At East Carolina University | Greenville | North Carolina | 27834 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |