Alternatives to Opioids for Pain After Tooth Extraction

(ADOPT Trial)

Overseen By Jennifer Dolly Prothro, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Douglas Oyler

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

Compensation: Varies

Number of Visits: 2

38159 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are: * Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal? * Do oral surgeons' beliefs about the intervention and opioid prescribing change? * Do patients that report using opioids after tooth removal have different experiences than patients that do not? Oral surgeon participants will: * Attend a 1-hour education session with a trained pharmacist * Receive patient instructions and blister packs of pain medicine to give to patients * Complete 2 surveys about feasibility and appropriateness Patient participants will complete a survey about pain and medication use after having a tooth removed. Researchers will compare the intervention to usual care to see if it reduces opioid prescribing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing opioid prescriptions after tooth extraction, so it's best to discuss your current medications with the trial team.

Is the alternative treatment to opioids for pain after tooth extraction safe?

Research shows that using nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, often combined with acetaminophen, is generally safe and effective for managing pain after tooth extraction. These alternatives have fewer side effects compared to opioids, which can cause dizziness, nausea, and addiction. ^{1 2 3 4 5}

How does the multicomponent intervention treatment differ from other treatments for pain after tooth extraction?

The multicomponent intervention is unique because it combines nonsteroidal anti-inflammatory drugs (NSAIDs) with acetaminophen to effectively manage pain while minimizing the need for opioids, which are typically reserved for severe pain. This approach targets pain at multiple points in the body's pain pathways, offering a safer alternative to opioid-based treatments. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment Multicomponent intervention for pain after tooth extraction?

Research shows that combining nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen with acetaminophen is more effective for pain relief after tooth extraction than opioids or placebo. This suggests that a multicomponent approach, which may include these medications, could be effective in managing pain without relying on opioids. ^{4 5 9 10 11}

Who Is on the Research Team?

Douglas R Oyler, PharmD

Principal Investigator

University of Kentucky

Marcia V Rojas Ramirez, DDS

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults who are having teeth removed. Oral surgeons participating will need to attend an educational session, provide specific pain medications, and complete surveys. Patients must take a survey about their pain and medication use post-extraction.

Inclusion Criteria

Patient must read and acknowledge survey cover letter in lieu of a full consent/assent process

Participating clinics must meet specific criteria related to tooth extractions and opioid prescriptions

Patient must be able to access the electronic survey using an internet-capable device

Exclusion Criteria

There are no other exclusion criteria for clusters or provider/patient participants that meet all inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Oral surgeons attend a 1-hour education session, receive patient instructions and blister packs of pain medicine, and complete surveys about feasibility and appropriateness

3 months

1 visit (in-person) for education session, ongoing distribution of materials

Patient Follow-up

Patients complete a survey about pain and medication use after tooth extraction

1 week

1 survey (virtual)

Provider Follow-up

Provider participants complete a survey to assess implementation outcomes approximately 3 months after transitioning into the intervention condition

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Multicomponent intervention

Trial Overview The study tests if a three-part intervention can cut down opioid prescriptions after tooth removal compared to usual care. It includes education for oral surgeons, special patient instructions, and blister packs of non-opioid pain medicine.

How Is the Trial Designed?

Group I: Intervention condition Experimental Treatment 1 Intervention

1. Academic detailing (45 to 60-minute session), plus 2. Provision of standardized patient post-extraction instructions for distribution, plus 3. Provision of blister-packaged acetaminophen and ibuprofen at recommended standard doses for distribution to to adolescent/young adult patients after tooth extraction in the course of clinical practice

Group II: Control condition Active Control 1 Intervention

Usual practice

Who Is Running the Clinical Trial?

Douglas Oyler

Lead Sponsor

Trials

1

Recruited

38,200+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Association of Opioid Use With Pain and Satisfaction After Dental Extraction. [2021]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Comparative analysis of the effectiveness of SF-MPQ-2 and VAS for assessing the severity of pain syndrome in dental patients in the postoperative period]. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of quick-release lornoxicam versus placebo for acute pain management after dental implant surgery: a randomised placebo-controlled triple-blind trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acute Postoperative Pain Due to Dental Extraction in the Adult Population: A Systematic Review and Network Meta-analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Factors influencing opioid prescribing after tooth extraction. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Comment on controlling dental post-operative pain and the intraoral local delivery of drugs. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Nonsteroidal Anti-Inflammatory Drugs and Opioids in Postsurgical Dental Pain. [2021]

8. England pubmed.ncbi.nlm.nih.gov

A randomized pilot program to reduce opioid use following dental surgery and increase safe medication return. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Prescribing Analgesics for Postoperative Dental Pain. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

New Approaches to Pain Management. [2020]

11. England pubmed.ncbi.nlm.nih.gov

The pharmacological management of dental pain. [2020]