Status:
NOT_YET_RECRUITING
Reducing Opioid Use and Misuse After Wisdom Molar Extractions
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
iPill Dispenser
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Reducing opioid prescription related use and misuse is a major focus for countering the national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly young and healthy indiv...
Detailed Description
Reducing opioid prescription related use and misuse is a major focus for countering the national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly young and healthy indiv...
Eligibility Criteria
Inclusion
- Adults (\> 18)
- American Society of Anesthesiologists Classification I
- No h/o temporomandibular disorder (TMD) symptoms
- No h/o trauma to jaws/teeth
- No h/o surgery in maxillofacial region
- Presenting for extraction of at least 1 mandibular partially bony/ full bony impacted 'wisdom' or third molar/s under intravenous sedation
- iPhone or Android smart phone (compatible with iPill® App)
- Informed consent
- No cognitive/intellectual disability
- Not from vulnerable population
Exclusion
- Acute infection or pain in relation to the impacted molars on day of procedure
- h/o opioid prescription for acute/chronic pain
- h/o of allergy or contraindication to amide-type local anesthetics, epinephrine or opioids
- Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)/muscle relaxants/other prescriptions to manage pain/inflammation
- Refusal/inability to use iPill® App or dispenser
- h/o eczema
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT04414917
Start Date
November 1 2024
End Date
April 1 2027
Last Update
March 20 2024
Active Locations (1)
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1
Rutgers Health University Dental Associates
New Brunswick, New Jersey, United States, 08901