Reducing Opioid Use and Misuse After Wisdom Molar Extractions
Status:
Not yet recruiting
Trial end date:
2024-04-01
Target enrollment:
Participant gender:
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.