Preoperative Survey to Evaluate Patient Allergy

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Pediatric; Allergic Reaction; Allergy Drug
• Intervention / Treatment: Other: Survey

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for surgery at a children's hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medication allergy; Patients who have a medication allergy listed in their electronic medical record.	Other: Survey; Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
True Allergy (Consistent With an IgE-mediated Reaction)	Cutaneous reactions (hives, urticarial, skin redness, rash) within 6 h of the dose or Anaphylaxis or anaphylactoid reaction within 6 h of the dose	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction)	Cutaneous reactions (rash, skin redness) longer than 6 h after the dose	Baseline
Not True Allergy (Not Related to IgE-mediated Reaction)	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	Baseline

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: STUDY00002974

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No