Reducing Opioid Use and Misuse After Wisdom Molar Extractions

NCT04414917 | Not Yet Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: Pro20190027391 R21 DA051212-01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain, Postoperative

Keywords

Impacted third molar extraction; Acute pain management; Active pill dispenser; Opioid misuse reduction

Outcome Measures

Primary Outcomes (2)

• Numerical Pain Rating Scale score (NRS)

  Scale from 0 to 10 used to describe no pain (0), mild pain (1-3), moderate (4-6) and severe (7-10) pain. Collection of peak post-procedure, mean, median, quartile pain scores

  Change in NRS pain scores between baseline and 96 hours post-pain regimen assignment

• Pain medication consumed (mg)

  Dosage of combination opioid, ibuprofen and acetaminophen consumed

  Through 96 hours post-procedure

Secondary Outcomes (6)

• Incidence of adverse events

  During the first 4 days following procedure

• iPill Dispenser performance- Validation of pills dispensed

  During the first 4 days following procedure

• iPill Dispenser performance- Incidence of dispenser tampering

  During the first 4 days following procedure

• iPill Dispenser performance- Incidence of failure of operability

  During the first 4 days following procedure

• iPill Dispenser performance- Percentage of returned dispensers

  During the first 4 days following procedure

Study Arms (2)

Twin Block local anesthetic

EXPERIMENTAL

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

Drug: Twin block; Device: iPill dispenser

Control

SHAM COMPARATOR

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

Device: iPill dispenser

Interventions

Twin block DRUG

Dental local anesthetic administered to target the jaw 'closer' muscles, temporalis and masseter

Twin Block local anesthetic

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).

Also known as: Active pill dispenser

Control; Twin Block local anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• iPill Dispenser: collaborator

Study Sites (1)

Rutgers Health University Dental Associates

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Gayathri Subramanian, PhD DMD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Anayo Adachie, DMD, MD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gayathri Subramanian, PhD, DMD

CONTACT

973 972 3418; subramga@sdm.rutgers.edu

Anayo Adachie, DMD, MD

CONTACT

732 235 5050; aoa80@sdm.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sham injection versus injection of local anesthetic as the Twin block
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective randomized blind clinical trial of patients undergoing lower third molar extraction/s to evaluate the ability of the Twin block (local anesthetic nerve block) on side of extraction to reduce post-operative pain and pain medication utilization monitoring with an active pill dispenser

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 4, 2020
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)