Study to Assess Dopamine Receptor Modulation With Rotigotine to Enhance Morphine Analgesia in the Dental Model
- Registration Number
- NCT02123979
- Lead Sponsor
- East Carolina University
- Brief Summary
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.
- Detailed Description
Inclusion Criteria:
* Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars
* Indicated for the removal of 3-4 third molars, at least two of which are categorized as partial-boney or full-boney impactions
* Self-report of moderate or severe pain on a categorical scale with a minimum of 5 out of 10 on the numerical rating scale following the offset of local anesthesia
Exclusion Criteria:
* History or intolerance to rotigotine
* Current or history of mental disorder or substance abuse
* Allergy or intolerance to opioids or local anesthetics
* Concurrent or recent use of agents that may confound the sedative effects of the study drug (opioids, benzodiazepines) over the previous 7 days or alcohol ingestion in the previous 24 hours
* Chronic or recent use of medications that might confound the effects of rotigotine, e.g., antihistamines, prescription or over-the-counter NSAIDs (Nonsteroidal anti-inflammatory drugs), acetaminophen, steroids, antidepressants, muscle relaxants.
* Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index \>35).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
-
• Male and female patients aged 18 and over scheduled to undergo elective oral surgery for the removal of impacted third molars
- Indicated for the removal of 3-4 third molars, at least two of which are categorized as partial-boney or full-boney impactions
- Self-report of moderate or severe pain on a categorical scale with a minimum of 5 out of 10 on the numerical rating scale following the offset of local anesthesia
-
History or intolerance to rotigotine
- Current or history of mental disorder or substance abuse
- Allergy or intolerance to opioids or local anesthetics
- Concurrent or recent use of agents that may confound the sedative effects of the study drug (opioids, benzodiazepines) over the previous 7 days or alcohol ingestion in the previous 24 hours
- Chronic or recent use of medications that might confound the effects of rotigotine, e.g., antihistamines, prescription or over-the-counter NSAIDs, acetaminophen, steroids, antidepressants, muscle relaxants.
- Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index >35).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neupro® transdermal patch Neupro® transdermal patch/placebo 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. placebo patch Neupro® transdermal patch/placebo 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.
- Primary Outcome Measures
Name Time Method Sum of pain intensity difference scores up to six months 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.
- Secondary Outcome Measures
Name Time Method Analgesic tablets taken postoperatively December 2014 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.
Trial Locations
- Locations (1)
School of Dental Medicine At East Carolina University
🇺🇸Greenville, North Carolina, United States