Reducing Opioid Use and Misuse After Wisdom Molar Extractions

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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 individuals undergo outpatient third molar ('wisdom tooth') tooth extractions under sedation and routinely receive postoperative opioid prescriptions. This procedure is among the most prevalent instances of opioid prescriptions dispensed to adolescents, a vulnerable population. This overuse can be minimized by bringing about immediate and sustained pain relief following extractions and by proper monitoring to regulate post-operative opioid usage.

The investigators developed the Twin block, a local anesthetic nerve block that rapidly eases pain from the 'closer' muscles of the jaw and showed its long-term effectiveness in patients with chronic jaw muscle pain. Administering the Twin block immediately following third molar extractions will be an innovative and effective modality to alleviate acute post-procedure pain experienced by the patient and hence reduce the need for post-operative opioid pain medication.

In order to tightly regulate when, how many and to whom the prescribed opioid pill is accessible, this study will utilize the iPill Dispenser®, an active pill dispenser. The iPill device, designated as a Class I 510(k) exempt device by the FDA, includes an App that utilizes biometric user authentication to operate a portable tamper-resistant, pre-calibrated device to regulate, deliver, and monitor opioid usage for pain, preventing overconsumption and diversion. The investigators further plan to 'track' pill swallowing by encapsulating the medication with an ingestible event marker (IEMs, FDA approved Class II device). The hypothesis of this study is that reduction in opioid prescription and its unwarranted use following third molar extractions can be achieved by a combination of Twin block, an active pill dispenser and ingestion tracking. The Specific Aims are:

Specific Aim 1. Compare highest pain after third molar tooth extractions, in patients with and without the twin block.

Specific Aim 2. Compare postoperative opioid consumption during the first 4 days following third molar tooth extractions between patients who got the twin block, with those who do not. Using the iPill dispenser and app and the IEM, the investigators will track opioid consumption for severe pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Collaborator: iPill Dispenser

Criteria

Inclusion Criteria:

1. Adults (> 18)

2. American Society of Anesthesiologists Classification I

3. No h/o temporomandibular disorder (TMD) symptoms

4. No h/o trauma to jaws/teeth

5. No h/o surgery in maxillofacial region

6. Presenting for extraction of at least 1 mandibular partially bony/ full bony impacted 'wisdom' or third molar/s under intravenous sedation

7. iPhone or Android smart phone (compatible with iPill® App)

8. Informed consent

9. No cognitive/intellectual disability

10. Not from vulnerable population

Exclusion Criteria:

1. Acute infection or pain in relation to the impacted molars on day of procedure

2. h/o opioid prescription for acute/chronic pain

3. h/o of allergy or contraindication to amide-type local anesthetics, epinephrine or opioids

4. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)/muscle relaxants/other prescriptions to manage pain/inflammation

5. Refusal/inability to use iPill® App or dispenser

6. h/o eczema