Remimazolam + Fentanyl for Tooth Extractions

Recruiting in Palo Alto (17 mi)

Overseen bykyle j kramer, DDS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Indiana University

No Placebo Group

Prior Safety Data

Trial Summary

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).

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 18 years or older on the day of my surgery.

+1 more

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.

+4 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Fentanyl and Remimazolam combinedExperimental Treatment1 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.