The Nonirritating Concentrations of Midazolam, Ketamine, and Ondansetron

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2026-10-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

Study team is developing a new diagnostic skin testing procedure to determine non-irritant concentrations of midazolam, ketamine and ondansetron administered to patients before, during or after surgery.

Group Type EXPERIMENTAL

Skin Testing

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Skin 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes