Preoperative Survey to Evaluate Patient Allergy

Completed

• Conditions: Allergy Drug; Allergic Reaction; Surgery; Pediatric
• Interventions: Other: Survey

• Registration Number: NCT05670756
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-20
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2023-01-04
• Study Start: 2023-05-01
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-13
• Results First Submitted: 2024-06-17
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Results First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medication allergy	Survey	Patients who have a medication allergy listed in their electronic medical record.

Primary Outcome Measures

Name	Time	Method
True Allergy (Consistent With an IgE-mediated Reaction)	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 Outcome Measures

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

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States