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

NCT07011472 | Recruiting

• 1 other identifier: Pro2025000930
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Shared Decision Making

Keywords

Analgesic selection; shared decision making; decision aid; non-opioid analgesic

Outcome Measures

Primary Outcomes (1)

• % participants selecting opioid analgesics versus non-opioid analgesics

  •To determine difference in proportion of patients who choose an opioid option for analgesics after participation in a shared decision making process using a decision aid

  Day 1

Study Arms (2)

Decision-Aid with 2-options

ACTIVE COMPARATOR

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.

Other: Decision-Aid with 2-options

Decision-Aid with 3-options

ACTIVE COMPARATOR

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.

Other: Decision aid with 3 options

Interventions

Decision-Aid with 2-options OTHER

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

Decision-Aid with 2-options

Decision aid with 3 options 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.

Decision-Aid with 3-options

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 8, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)