Post-op Pain
Conditions
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).
Interventions
DRUGNeupro® transdermal patch/placebo
8mg transdermal patch Neupro® transdermal patch/placebo
Sponsors
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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, 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| assess pain | up 48 hours | 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. |
Countries
United States
Outcome results
None listed