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

Trial Summary

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 data supports the effectiveness of the drug combination Remimazolam and Fentanyl for tooth extractions?

Research shows that Remimazolam, when used with Fentanyl, provides effective sedation for procedures, with studies indicating that this combination works well for procedural sedation by enhancing the sedative effects. Additionally, Fentanyl combined with other sedatives has been shown to offer good sedation and pain relief during dental surgeries. ^{1 2 3 4 5}

Is the combination of remimazolam and fentanyl safe for use in dental procedures?

Studies suggest that remimazolam, when used with similar medications like alfentanil, is generally safe for dental procedures, with no significant adverse events reported. Patients and clinicians were satisfied, and the combination was well tolerated with a low risk of side effects. ^{2 3 6 7 8}

How does the drug combination of Remimazolam and Fentanyl for tooth extractions differ from other treatments?

The combination of Remimazolam and Fentanyl for tooth extractions is unique because Remimazolam is an ultra-short acting benzodiazepine that provides rapid sedation with a quick recovery time, and when combined with Fentanyl, it offers a synergistic effect that enhances sedation. This combination is particularly beneficial for procedural sedation, offering a potentially better recovery profile compared to traditional sedatives like midazolam. ^{2 3 4 5 9}

What is the purpose of this trial?

The goal of this clinical trial is to learn if a combination of the two established sedation drugs remimazolam and fentanyl, can put the subject to sleep during a scheduled extraction procedure. The combined use of these drugs has been used in other studies involving IV sedation when the procedure is scheduled for 30 minutes or less. However, the combined use of the IV sedation drugs has not been used in a dental extraction procedure before. The main questions it aims to answer are: 1. Can the combined drugs effectively put the patient to sleep during the procedure 2. How quickly will they come out of the sedation after the procedure Participants will: 1. Receive the combined drugs during a scheduled extraction procedure anticipated to take less than 30 minutes 2. Answer survey questions related to their study experience after the extraction visit (in person) and again about 24 hours after the visit (by telephone).

Research Team

kyle j kramer, DDS

Principal Investigator

Indiana University

Eligibility Criteria

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

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

I have no health issues preventing sedation and can follow pre-sedation instructions.

My BMI is over 30.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

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

Comparison of a bolus of fentanyl with an infusion of alfentanil during target-controlled propofol infusion in third molar extraction under conscious sedation. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of continuous intravenous remimazolam versus midazolam in the extraction of impacted wisdom teeth: protocol of a randomised controlled trial. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Moderate sedation by total intravenous remimazolam-alfentanil vs. propofol-alfentanil for third molar extraction: A prospective randomized controlled trial. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

Comparison of dexmedetomidine/fentanyl with midazolam/fentanyl combination for sedation and analgesia during tooth extraction. [2022]

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

A population pharmacodynamic Markov mixed-effects model for determining remimazolam-induced sedation when co-administered with fentanyl in procedural sedation. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Perioperative analgesic efficacy and adverse events of fentanyl in dentistry: A systematic review. [2023]

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

Evaluation of patient-controlled remifentanil application in third molar surgery. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Remimazolam Pilot for Office-Based Dental Sedation: Adverse Events, Awareness and Outcomes. [2023]

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

A prospective randomized controlled trial of two different sedation sequences for third molar removal in adults. [2022]