Preoperative Survey to Evaluate Patient Allergy

NCT05670756 | Completed Results

• 1 other identifier: STUDY00002974
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy Drug; Allergic Reaction; Pediatric; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline

• Not True Allergy (Not Related to IgE-mediated Reaction)

  Baseline

Study Arms (1)

Medication allergy

Patients who have a medication allergy listed in their electronic medical record.

Other: Survey

Interventions

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.

Medication allergy

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for surgery at a children's hospital.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Drug Hypersensitivity; Hypersensitivity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Joseph D. Tobias, MD
• Organization: Nationwide Children's Hospital

joseph.tobias@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 4, 2023
• Study Start: May 1, 2023
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)