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The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron

The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07103720
Enrollment
21
Registered
2025-08-05
Start date
2025-11-05
Completion date
2026-03-10
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Brief summary

Perioperative anaphylaxis is a potentially life-threatening drug allergic reaction that can occur during anesthetic procedures. The purpose of this research is to determine the maximal nonirritating skin testing concentrations of midazolam, ketamine and ondansetron. These drugs are FDA approved and commonly used before, during and after surgical procedures.

Interventions

DIAGNOSTIC_TESTSkin Testing

Participants will undergo skin prick testing and intradermal test injections at 5 increasing concentrations of midazolam, ketamine and/or ondansetron during one single study visit.

Sponsors

Mayo Clinic
Lead SponsorOTHER
Arizona Biomedical Research Commission (ABRC)
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Not have a history of an adverse reactions to midazolam, ketamine or ondansetron * Ability to understand study procedures and to comply with them for the entire length of the study. * Contraception is not necessary, and we will include women of reproductive capability.

Exclusion criteria

* Unstable patients. * History of any adverse reaction (allergy or sensitivity) to midazolam, ketamine or ondansetron. * Pregnant and Pediatric patients * Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron.1 DayDetermine the maximal nonirritating concentrations of midazolam, ketamine and ondansetron

Secondary

MeasureTime frameDescription
Skin Testing Results1 DayDetermine the frequency of false positive test results in patients who have received Midazolam, Ketamine or Ondansetron in the past.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlexei Gonzalez Estrada, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026