Oral Challenge in the Pediatric ED
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 3 - 16 |
| Updated: | 1/21/2018 |
| Start Date: | December 4, 2017 |
| End Date: | December 4, 2018 |
| Contact: | David E Vyles, DO, MS |
| Email: | dvyles@mcw.edu |
| Phone: | 414-337-3227 |
Oral Penicillin Challenge in the Pediatric Emergency Department
Our primary objective is 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 in the PED to test for an IgE-mediated allergic reaction. This project will
begin as a single site feasibility study, however including up to 2 other collaborative sites
for enrollment has been favorably discussed. We do not anticipate this to be a single IRB
scenario and will submit a timely comprehensive amendment if plans become concrete and the
initial data here proves reliable.
Our secondary objective is to examine whether health care outcomes and prescription-related
costs are comparable between children who are de-labeled as penicillin allergic after an oral
challenge compared to a standard of care group who are not challenged in the PED.
allergy questionnaire in the PED to identify a low-risk group of patients who will complete
an oral challenge in the PED to test for an IgE-mediated allergic reaction. This project will
begin as a single site feasibility study, however including up to 2 other collaborative sites
for enrollment has been favorably discussed. We do not anticipate this to be a single IRB
scenario and will submit a timely comprehensive amendment if plans become concrete and the
initial data here proves reliable.
Our secondary objective is to examine whether health care outcomes and prescription-related
costs are comparable between children who are de-labeled as penicillin allergic after an oral
challenge compared to a standard of care group who are not challenged in the PED.
Inclusion Criteria:
- Children aged 3-16 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 Criteria:
- 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, pregnancy, child took any
antihistamine in the past three days [including diphenhydramine (Benadryl®),
cetirizine (Zyrtec®), loratadine (Claritin®), fexofenadine (Allegra®), levocetirizine
(Xyzal®), and desloratadine (Clarinex®)] or 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 being admitted to the hospital or those who are 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.
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