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OpenTrials
Completed

NCT Number: NCT05670756

Preoperative Survey to Evaluate Patient Allergy

The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing. The purpose is to evaluate demographics and prevalence of allergies in patients presenting for surgery, evaluate the medical decision making process behind allergy identification, and determine its potential impact on perioperative care. The participants will be asked to complete a survey in REDCap using an iPad during the visit.

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Key information

Conditions

Allergy Drug Allergic Reaction Chemically-Induced Disorders Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Hypersensitivity Immune System Diseases Pediatric Surgery

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 0-21 years of age presenting for surgery or procedure requiring anesthesia

Exclusion criteria

  • Patients who are not able cognitively to complete the computerized survey due to physical or intellectual impairment or communication issues related to non-English speaking patients

Treatment and study plan

Survey

Other

Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.

Primary outcomes

  1. True Allergy (Consistent With an IgE-mediated Reaction)

    Time frame: Baseline

    Cutaneous reactions (hives, urticarial, skin redness, rash) within 6 h of the dose or Anaphylaxis or anaphylactoid reaction within 6 h of the dose

Secondary outcomes

  1. Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction)

    Time frame: Baseline

    Cutaneous reactions (rash, skin redness) longer than 6 h after the dose

  2. Not True Allergy (Not Related to IgE-mediated Reaction)

    Time frame: Baseline

    Allergy listed in the medical record but instead: Recognized adverse effect of the medication, Family history of allergy, Based on medical history or other reasons, or Parents reported their child has no allergy

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Preoperative Survey to Evaluate Patient Allergy List, Type of Response to Listed Medication, and Its Relevance to Perioperative Care

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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