Skin Testing for Allergy

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Unstable, Pregnant, Pediatric, 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: 1

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine safe and non-irritating doses for skin tests using three drugs: midazolam, ketamine, and ondansetron. These drugs are commonly used before, during, or after surgery, and the trial focuses on understanding potential allergic reactions during these times. Individuals who have not experienced adverse reactions to these drugs and can adhere to the study procedures are suitable candidates. Participants will assist researchers in ensuring these drugs do not cause skin irritation or allergies. As a Phase 4 trial, this research helps clarify how these FDA-approved and effective treatments can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the skin testing procedure?

Research has shown that skin tests for drugs like midazolam, ketamine, and ondansetron are generally safe. One study found that these tests effectively identify allergic reactions without causing harm. Another study indicated that repeating the test, even if the first shows no reaction, can safely identify the right drug.

Research also found that skin testing is safe for pregnant women, with only 4% experiencing mild reactions. This suggests that skin tests for these drugs are well-tolerated and generally safe for most people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this trial because it aims to develop a new diagnostic skin testing method for identifying non-irritant concentrations of medications like midazolam, ketamine, and ondansetron. Unlike traditional allergy tests that might not account for the unique reactions patients might have to these specific drugs, this new procedure focuses on surgical settings. This approach could lead to safer and more personalized medication management for patients undergoing surgery, reducing the risk of adverse reactions.

What evidence suggests that this skin testing procedure is effective for determining non-irritant concentrations of midazolam, ketamine, and ondansetron?

Research has shown that skin tests can help identify drugs that might cause allergic reactions during surgery. This trial is developing a new diagnostic skin testing procedure to determine non-irritant concentrations of midazolam, ketamine, and ondansetron. The aim is to find the highest dose for skin testing that doesn't cause irritation. While skin tests might not always pinpoint the exact drug causing the reaction, they are useful for narrowing down possible allergies. These tests are a standard practice for better managing drug allergies during surgery. ^{4 6 7 8 9}

Who Is on the Research Team?

Alexei Gonzalez Estrada, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who may have allergies to certain drugs used in anesthesia, specifically midazolam, ketamine, and ondansetron. Participants should be able to undergo skin testing procedures.

Inclusion Criteria

Not have a history of adverse reactions to midazolam, ketamine, or ondansetron

Contraception is not necessary, and women of reproductive capability will be included

I understand and can follow the study's procedures.

Exclusion Criteria

Unstable patients

History of any adverse reaction (allergy or sensitivity) to midazolam, ketamine, or ondansetron

Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo skin testing to determine non-irritant concentrations of midazolam, ketamine, and ondansetron

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse reactions following the skin testing

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Skin Testing

Trial Overview The study aims to find the highest concentrations of midazolam, ketamine, and ondansetron that can be applied during skin tests without causing irritation. This will help improve safety in patients undergoing surgery.

How Is the Trial Designed?

Group I: Study Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Arizona Biomedical Research Commission (ABRC)

Collaborator

Trials

3

Recruited

210+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8606328/

Successful identification of culprit drugs of perioperative ... Repeated skin tests after negative results of the first tests may identify the causative drugs, thus providing optimal patient safety.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07103720/the-nonirritating-concentrations-of-midazolam-ketamine-and-ondansetron

The Nonirritating Concentrations of Midazolam, Ketamine ... The purpose of this research is to determine the maximal nonirritating skin testing concentrations of midazolam, ketamine and ondansetron.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6004007/

practical recommendations for allergy testing and patient ... Although it is often not possible to establish the clinical relevance of positive skin tests to anesthetics, including NMBA, thereby unequivocally identifying ...

4. jiaci.org jiaci.org/revistas/vol30issue2_3.pdf

Drug Challenge Tests With General Anesthetics: Predictive ... In our study, the skin test results were negative in 100% of the reactions due to anesthetics, which could only be diagnosed by DCT.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949913524000090

Review Allergy in perioperative setting This review will cover allergic reactions caused by local anesthetics, reagents used during anesthesia/operating room, and emerging reaction in patients with α ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12240923/

Towards standardized skin testing for drug-induced allergic ... One of the main advantages of the IDT is its high sensitivity and accuracy in identifying a specific allergic reaction, and there is no further ...

7. withpower.com withpower.com/trial/phase-4-hypersensitivity-7-2025-dee13

Skin Testing for Allergy · Info for Participants The purpose of this research is to determine the maximal nonirritating skin testing concentrations of midazolam, ketamine and ondansetron. These drugs are FDA ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2405844021025044

Successful identification of culprit drugs of perioperative ... Repeated skin tests after negative results of the first tests may identify the causative drugs, thus providing optimal patient safety.

9. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(20)30816-3/fulltext

Practical Guidance for the Evaluation and Management ... Skin testing was also found to be safe in 56 pregnant women with group B Streptococcus colonization, with only 2 (4%) women experiencing a mild reaction during ...