Reducing Opioid Use and Misuse After Wisdom Molar Extractions

Conditions

• Pain, Postoperative

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Twin block — DRUG
  Dental local anesthetic administered to target the jaw 'closer' muscles, temporalis and masseter
• iPill dispenser — DEVICE
  An active pill dispenser, regulated by patient's pain score entered on an iPill App installed on their smart phone (iPhone, Android) to dispense opioid (for pain corresponding to severe pain) or prescription strength ibuprofen and acetaminophen (for moderate pain), with over the counter solutions for mild pain recommended. This pill dispenser will be given to all patients, in both Twin block and Control groups, to regulate and monitor their pain experience-driven pain medication regimen. The pill dispenser will be packaged with pain medication (1 dispenser with vicodin, 1 with prescription ibuprofen, 1 with acetaminophen) that has been coencapsulated with ingestible event markers (IEMs, Proteus Discover).

Study Details

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.

Key Dates

Start date

Nov 30, 2024

Status verified

Mar 2024

Primary completion

Nov 30, 2026

Completion

Apr 30, 2027

Study Design

Enrollment

133 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Twin Block local anesthetic
  Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block local anesthetic (using the standard dental anesthetic 1.8 cc 2% lidocaine with 1:100,000 epinephrine), once, on the side/s of their extraction/s
• Sham Comparator: Control
  Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block injection but with no medication administered/dispensed from the syringe, on the side/s of their extraction/s

Primary Outcome Measure

Numerical Pain Rating Scale score (NRS) [ Time Frame: Change in NRS pain scores between baseline and 96 hours post-pain regimen assignment ]

Central Contacts

• Gayathri Subramanian, PhD, DMD
  973 972 3418
  [email protected]
• Anayo Adachie, DMD, MD
  732 235 5050
  [email protected]

Locations (1)

Find similar trials in New Brunswick, NJ

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