Remimazolam + Fentanyl for Tooth Extractions

Overseen By kyle j kramer, DDS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Indiana University

Must not be taking: Opioids, Analgesics, Alcohol, Illicit

Disqualifiers: Allergy, BMI >30, Comorbidities, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of two sedation drugs, remimazolam and fentanyl, can safely and effectively sedate patients during quick tooth extractions. Researchers aim to determine if these drugs help patients remain asleep throughout the procedure and how quickly they awaken afterward. Suitable candidates for this trial are healthy adults scheduled for a tooth extraction lasting under 30 minutes, with no history of negative experiences with similar sedation. Participants will receive the sedation drugs during their procedure and provide feedback afterward. As a Phase 4 trial, this study involves FDA-approved drugs and seeks to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use opioid-containing painkillers or consume alcohol or certain drugs within 24 hours before the procedure.

What is the safety track record for the combination of remimazolam and fentanyl?

Research shows that remimazolam, when combined with fentanyl, is generally safe and well-tolerated for sedation during short procedures. Studies have found that remimazolam effectively keeps patients calm, with a low risk of side effects. Fentanyl, a strong pain reliever, works well with sedatives like remimazolam to maintain patient comfort.

Previous research using similar drug combinations has shown positive results for sedation with few side effects. The combination of remimazolam and other pain relievers like alfentanil has proven effective and safe in dental procedures. Both remimazolam and fentanyl have FDA approval for use in other procedures, indicating thorough safety studies.

In summary, research suggests that using remimazolam and fentanyl together is likely safe for short dental procedures such as tooth extractions. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using remimazolam combined with fentanyl for dental extractions because this combination offers potentially smoother and safer sedation. Unlike traditional sedatives used in dentistry, which can vary in onset and duration, remimazolam provides quick onset and recovery, making it ideal for short procedures. Plus, remimazolam’s unique mechanism allows for better control over the sedation level, which could improve patient comfort and safety. This combination has yet to be explored in U.S. dental settings, marking a promising advancement in procedural sedation.

What evidence suggests that this treatment might be an effective treatment for dental extractions?

Research has shown that remimazolam, when combined with fentanyl, effectively keeps patients calm and comfortable during short medical procedures. This combination reduces anxiety and ensures a smooth experience. The FDA has already approved remimazolam for sedation, and it has been safely used in various situations. Although not specifically tested for dental extractions in the US, it has proven effective in similar cases. This trial will evaluate the efficacy of remimazolam with fentanyl for procedural sedation during tooth extractions, suggesting it could help keep patients relaxed. ^{1 2 3 4 6}

Who Is on the Research Team?

kyle j kramer, DDS

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for patients needing dental extractions, who can safely receive IV sedation and are available to answer survey questions after the procedure. Specific eligibility criteria details were not provided.

Inclusion Criteria

My dental procedure under sedation will take 30 minutes or less.

Willing to read and sign the IRB approved informed consent document

I am generally healthy with no or mild systemic disease.

Exclusion Criteria

My BMI is over 30.

Previous negative history with the use of IV sedation medications

I haven't taken any opioid painkillers within 24 hours before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive remimazolam and fentanyl for procedural sedation during a dental extraction procedure anticipated to take less than 30 minutes

1 day

1 visit (in-person)

Immediate Post-Procedure Monitoring

Participants are monitored for emergence from sedation and fitness for discharge, including assessment of vital signs and completion of satisfaction surveys

1-2 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up survey conducted approximately 24 hours post-procedure

1 day

1 visit (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Fentanyl
• Remimazolam

Trial Overview The study tests if remimazolam combined with fentanyl can effectively and safely sedate patients during short dental extraction procedures (under 30 minutes) and how quickly they recover from sedation.

How Is the Trial Designed?

Group I: Fentanyl and Remimazolam combined Experimental Treatment 1 Intervention

Remimazolam has received FDA approval for procedural sedation in adults undergoing procedures lasting 30 minutes or less. While remimazolam has been used in studies for procedural sedation outside of dentistry and oral surgery, there are no dental studies from the US that have assessed its safe and effect use along with fentanyl as described in the package insert. This single-armed study will assess the efficacy of FDA-approved remimazolam combined with fentanyl for procedural sedation (defined as MOAA/S score ≥2) in healthy (ASA 1 and 2) adults undergoing dental extractions expected to last 30 minutes or less. To date, there are no studies in the US that have assessed the effectiveness of remimazolam and fentanyl for procedural sedation for dental treatment, including extractions, so this is the first study of its kind.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06793358

Use of Remimazolam and Fentanyl for Procedural ... This single-armed study will assess the efficacy of FDA-approved remimazolam combined with fentanyl for procedural sedation (defined as MOAA/S score ≥2) in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0266435624000846

Efficacy and cost analysis of intravenous conscious ... The aim of this study was to determine what is considered a long oral surgery and conduct a cost-effective analysis of sedative agents used for intravenous ...

3. nature.com nature.com/articles/s41415-023-5889-3

Effectiveness and safety of dentist-led conscious sedation ... In this evaluation, the synergistic effects of fentanyl and midazolam resulted in enhanced sedation, anxiolysis and intraoperative conditions.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10707309/

Remimazolam Pilot for Office-Based Dental Sedation The remimazolam-alfentanil regimen appears to be well tolerated and effective for office-based dental procedures in adult patients, with a low risk of adverse ...

5. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/12952/use-of-remimazolam-and/

Use of Remimazolam and Fentanyl for Procedural Sedation This study investigates the use of a combination of two sedation drugs, remimazolam and fentanyl, for patients undergoing dental extractions.

6. e-ce.org e-ce.org/journal/view.php?number=7909

Remimazolam, a novel drug, for safe and effective ... The study concluded that remimazolam was safe and effective for procedural sedation ... remimazolam and propofol in combination with remifentanil.