Decision-Aids for Pain Management

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Inability to take ibuprofen, acetaminophen, opioids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new decision-making tool to help patients choose pain relief options after surgery. Patients will choose between non-opioid options (such as ibuprofen and acetaminophen) and opioid options (such as hydrocodone), with some also receiving a "just-in-case" opioid choice. Researchers aim to determine how the number of choices influences the decision to use opioids. This trial suits individuals planning to have wisdom teeth removed who can take ibuprofen, acetaminophen, or opioids. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance post-surgery pain management options.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. However, it focuses on choosing between different pain medications after surgery, so you might not need to change your current meds unless they interfere with the trial's pain management options.

What prior data suggests that this behavioral intervention is safe for post-operative pain management?

Research has shown that both decision-aid options involve well-known pain medications extensively studied. In the decision aid with two options, participants can choose between a non-opioid mix of ibuprofen and acetaminophen or an opioid called hydrocodone. Both medications are commonly used and generally well-tolerated. Ibuprofen and acetaminophen are widely used for pain relief and are safe when used as directed.

The decision aid with three options includes an additional choice: a non-opioid combination plus a "just-in-case" opioid prescription. Studies indicate that having more choices can help patients manage their pain better and make informed decisions. Hydrocodone, the opioid in this option, effectively relieves pain but can cause side effects like drowsiness or nausea. However, it remains safe when used as prescribed.

Overall, these medications are generally considered safe when taken according to guidelines. The decision aids assist patients in making choices that fit their needs and comfort levels, potentially improving their pain management experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision-Aid for Pain Management trial because it explores new ways to empower patients in their post-operative pain management choices. Unlike standard practices where doctors typically prescribe pain medications, this trial tests a decision aid tool that involves patients in the decision-making process. One version of this tool lets patients choose between two options: a non-opioid pain reliever or an opioid. The other version offers a third option that combines a non-opioid pain reliever with an opioid prescription for "just-in-case" situations. By involving patients directly, researchers hope to find out if these decision aids can lead to more personalized and potentially safer pain management strategies.

What evidence suggests that this decision-aid protocol is effective for pain management?

This trial will compare two decision-aid tools for post-operative pain management. Participants in one arm will use a decision aid offering two options: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone). Studies have shown that such tools help patients make more informed decisions about managing post-surgical pain. Another arm in this trial will use a decision aid with three options, adding a "just-in-case" opioid prescription to the non-opioid and opioid choices. Evidence suggests that assessing pain individually, along with these decision tools, improves pain management. These tools aim to provide effective pain relief while reducing unnecessary opioid use. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for patients planning to have their third molars (wisdom teeth) extracted. Participants should be interested in being part of a process where they choose their painkiller after surgery by using a decision-aid tool. Specific eligibility criteria are not provided.

Inclusion Criteria

Be able to understand all directions for data gathering instruments in English

Be able to understand the informed consent

Provide signed and dated informed consent form

Exclusion Criteria

Prior participation in this study

Inability or refusal to provide informed consent

I cannot take ibuprofen, acetaminophen, or opioids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants undergo a shared decision making process using a decision aid to select post-operative analgesics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for their choice of analgesic and any subsequent outcomes

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Decision-Aid with 2-options
• Decision aid with 3 options

Trial Overview The study tests how presenting different numbers of pain management options affects patient choice. One group uses a decision aid with two analgesic options, while the other has three, including an 'as-needed' opioid option.

How Is the Trial Designed?

Group I: Decision-Aid with 2-options Active Control 1 Intervention

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 II: Decision-Aid with 3-options Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07011472?draw=2&rank=1

Study Details | NCT07011472 | Post-Operative Analgesic ... This decision aid offers 3 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen), an opioid (hydrocodone), or a non-opioid ...

2. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07011472

Decision-Aid with 2-options and Decision aid with 3 options in ... This decision aid offers 2 options for post-operative analgesic: a non-opioid combination (ibuprofen/acetaminophen) or an opioid (hydrocodone).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147818/

Comprehensive Review on Personalized Pain Assessment ... Emerging evidence indicates that combining personalized pain assessment with multimodal interventions can significantly improve clinical outcomes.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589514122000615

Shared Decision-Making Tool for Opioid Prescribing After ... We developed an educational, shared-decision-making tool regarding postoperative pain medication for outpatient hand surgery.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6203421/

Estimating relative efficacy in acute postoperative pain Network meta-analysis is a useful analytical tool that increases our confidence in estimates of efficacy of analgesics in acute postoperative pain.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1526590006005128

Patients' Decision-Making Strategies for Managing ... The aim of this study was to identify the strategies used by postoperative patients to bring about pain management decisions. A single-group noncomparative ...

7. jopan.org jopan.org/article/S1089-9472(23)00919-X/fulltext

Postoperative Pain Relief After Ambulatory Laparoscopic ... Purpose. To examine whether patient involvement using a Patient Decision Aid has a positive effect on pain levels, by giving them an active role ...