Status:
COMPLETED
Oral Challenge in the Pediatric ED
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Penicillin Allergy
Pediatric Emergency Medicine
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
Brief Summary
Our primary objective was to demonstrate the feasibility of utilizing a novel penicillin allergy questionnaire in the PED to identify a low-risk group of patients who will complete an oral challenge i...
Detailed Description
A convenience sample of children aged 2 to 16 years who presented to the pediatric emergency department with a reported PCN allergy were administered an allergy questionnaire to determine risk-level d...
Eligibility Criteria
Inclusion
- Children aged 2-16 with a parent/guardian (hereafter termed parent) reported history of allergy to a penicillin antibiotic in which the reported allergic reaction occurred at least six months prior to the current PED visit.
- Only children well enough to be discharged to home at the conclusion of the PED visit are eligible.
Exclusion
- Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal).
- Any contraindication to allergy testing will also result in exclusion
- (i.e. history of a severe allergic reaction to skin tests,,
- anaphylaxis in the past six weeks,
- known pregnancy
- child has a history of a condition that requires a beta blocker medicine for cardiac conditions, high blood pressure, migraine headaches, or eye drops for glaucoma (e.g. propranolol, metoprolol, atenolol and Timoptic®, or Betoptic® eye drops).
- Children who present to the PED with a rash, vomiting or current asthma symptoms including coughing, wheezing or breathing problems will also be excluded to ensure these do not mask reactions to an oral challenge.
- Patients deemed too acutely ill for participation (triage level 1 or 2 or as determined by the ED patient care team) will be excluded from the study.
- During this pilot study, we will exclude non-English speaking families. However, in subsequent studies we will include the non-English speaking population.
- Children who are wards of the state, in foster care or police custody or detention will be excluded.
- Children with any basal condition (trauma, infection, minor accidents, etc..) will be able to participate in the study provided they and their family are willing and do not meet the above-mentioned exclusion criteria.
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2022
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03404804
Start Date
December 4 2017
End Date
December 4 2022
Last Update
May 16 2024
Active Locations (1)
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1
David Vyles
Milwaukee, Wisconsin, United States, 53226