Post-Operative Analgesic Selection in Patients Planned for Third Molar Extraction After Undergoing Shared Decision Making Using 2- Versus 3-Option Decision-Aids

NCT ID: NCT07011472

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2026-05-30

Brief Summary

This research protocol is exploring a behavioral intervention: shared decision making with the use of a decision aid to select a post-operative analgesic. Specifically, the investigators will examine the impact of shared decision making on analgesic selection for acute pain management when 2 options are presented to the patient as compared to 3 options which includes an opioid prescription for "just-in-case" pain management. The investigators hypothesize that significantly more patients will choice an opioid option when the "just-in-case option is included.

Detailed Description

Dentists often prescribe opioids to their patients to manage acute post-surgical pain, with hydrocodone/acetaminophen being the most commonly prescribed opioid combination. With an estimated 56 million tablets of hydrocodone prescribed to 3.5 million high school and young adults each year after third molar extractions, it is vitally important to develop the best evidence for acute pain management following dental procedures.

Dentists are among the leading prescribers of opioid analgesics, writing up to 12% of all opioid prescriptions and 31% of opioid prescriptions for young patients. Shared decision making is an integral component of patient-centered clinical care. Decision aids have been shown to be effective in improving patient satisfaction, and one study suggests shared decisions have the potential to decrease the number of opioids tablets prescribed. Shared decision making studies on analgesics selection for out-patient surgery, however, are limited and no studies have investigated the "just in case" phenomenon which send a message that the opioid options are better than the non-opioid options.

Conditions

Pain Management; Shared Decision Making

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Decision-Aid with 2-options

Participants in this arm will undergo a shared decision making process using a decision aid that offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone). Subsequently, their choice for post-operative analgesic will be recorded.

Group Type: ACTIVE_COMPARATOR

Decision-Aid with 2-options

Intervention Type: OTHER

This decision aid offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone).

Decision-Aid with 3-options

Participants in this arm will undergo a shared decision making process using a decision aid that offers 3 options for post-operative analgesic: \[1\] a non-opioid combination (ibuprofen/acetaminophen), \[2\] an opioid (hydrocodone), or \[3\] a non-opioid combination plus an opioid prescription for "just-in-case" pain management. Subsequently, their choice for post-operative analgesic will be recorded.

Group Type: ACTIVE_COMPARATOR

Decision aid with 3 options

Intervention Type: OTHER

This decision aid offers 3 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen), an opioid (hydrocodone), or a non-opioid combination with a "just-in-case" opioid prescription.

Interventions

Decision-Aid with 2-options

This decision aid offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone).

Intervention Type: OTHER

Decision aid with 3 options

This decision aid offers 3 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen), an opioid (hydrocodone), or a non-opioid combination with a "just-in-case" opioid prescription.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Be able to understand the informed consent.
• Provide signed and dated informed consent form
• Be able to understand all directions for data gathering instruments in English
• Be willing and able to comply with all study procedures
• Planning to undergo extraction of one or more 3rd molars
• Be 18 years or older

Exclusion Criteria

While the actual analgesic prescribed to the patient may be different then the analgesic selected by the participant (their actual analgesic is NOT part of the research protocol) participants who self-report inability to take ibuprofen, acetaminophen or an opioid are not eligible since the decision aid is designed to help a patient select between a combination of ibuprofen/acetaminophen and an opioid containing analgesic.

Participants would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:

• Prior participation in this study
• Inability or refusal to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Cecile A. Feldman, DMD

Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rutgers School of Dental Medicine

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Cecile A Feldman

Role: primary

feldman@rutgers.edu

973-972-4634

Other Identifiers

Pro2025000930

Identifier Type: -

Identifier Source: org_study_id