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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to manage pain after tooth extraction, focusing on reducing opioid use. It involves a multicomponent intervention, including a treatment plan with an education session for oral surgeons and providing patients with acetaminophen and ibuprofen in blister packs. The trial aims to determine if this approach can lower opioid prescriptions and change surgeons' views on pain management. Ideal participants are adolescents and young adults who have recently had a tooth extraction and can complete an online survey. The results will compare this new plan against usual care to assess its effectiveness in reducing opioid use. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management strategies without the constraints of traditional trial phases.

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.

What prior data suggests that this multicomponent intervention is safe for reducing opioid prescriptions after tooth extraction?

Studies have shown that taking ibuprofen and acetaminophen together can effectively manage pain after dental procedures. Research indicates this combination not only eases pain well but is also safe for patients. People often feel more satisfied with their pain relief compared to using opioids.

In this trial, participants will receive a focused education session and ibuprofen and acetaminophen in blister packs. This approach aims to reduce opioid use.

Previous studies have found that this combination is generally well-tolerated with few side effects. Most people taking ibuprofen and acetaminophen together do not experience serious side effects, making it a promising alternative to opioids for dental pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage pain after tooth extraction without relying on opioids. Unlike the standard practice of prescribing opioids, this approach combines academic detailing, detailed patient instructions, and pre-packaged acetaminophen and ibuprofen. This multicomponent intervention aims to provide effective pain relief while minimizing the risk of opioid addiction, offering a safer alternative for adolescents and young adults.

What evidence suggests that this trial's multicomponent intervention could be effective for reducing opioid prescriptions after tooth extraction?

This trial will compare a multicomponent intervention with usual practice for managing pain after tooth extraction. Research has shown that combining ibuprofen and acetaminophen can manage pain more effectively after tooth removal than opioids. Patients in those studies reported better pain relief in the first two days and expressed greater overall satisfaction with this combination. In this trial, the intervention includes educating oral surgeons about this method, which studies suggest can help reduce opioid prescriptions. Additionally, providing patients with clear instructions and pre-packaged pain medicines supports this non-opioid approach. This strategy aims to change prescribing habits and improve patient experiences without relying on opioids. ^{3 4 6 7 8}

Who Is on the Research Team?

Marcia V Rojas Ramirez, DDS

Principal Investigator

University of Kentucky

Douglas R Oyler, PharmD

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10996080/

Alternatives to dental opioid prescribing after tooth ... Academic detailing for the ADOPT study will focus on 5 key messages: Use acetaminophen and ibuprofen first line for pain management.

2. scholars.uky.edu scholars.uky.edu/en/publications/alternatives-to-dental-opioid-prescribing-after-tooth-extraction-

Alternatives to dental opioid prescribing after tooth extraction ... The intervention consists of prescriber education via academic detailing plus provision of standardized patient post-extraction instructions and blister packs ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38575929/

Alternatives to dental opioid prescribing after tooth extraction ... Discussion: This real-world study will address an important need, providing information on the effectiveness of a multicomponent intervention at ...

4. jada.ada.org jada.ada.org/article/S0002-8177(24)00639-1/fulltext

Nonopioid vs opioid analgesics after impacted third-molar ... The ibuprofen and acetaminophen combination managed pain better for the first 2 days and led to greater satisfaction over the entire postoperative period.

5. withpower.com withpower.com/trial/phase-acute-pain-3-2024-45497

Alternatives to Opioids for Pain After Tooth Extraction · Info ... Research shows that combining nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen with acetaminophen is more effective for pain relief after tooth ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7419400/

Evaluation of Fixed-Dose Combinations of Ibuprofen and ... The present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002817714605092

Combining ibuprofen and acetaminophen for acute pain ... Combining ibuprofen with APAP provides dentists with an additional therapeutic strategy for managing acute postoperative dental pain.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01559259

Study Details | NCT01559259 | Evaluation of the Efficacy of ... This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and ...