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Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02036840
Enrollment
513
Registered
2014-01-15
Start date
2013-01-31
Completion date
2014-11-30
Last updated
2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penicillin Allergy

Brief summary

The proposed research project will retrospectively review the anesthetic records over the past 5 years and identify patients who present with a history of penicillin allergy or allergy to an antibiotic in the penicillin family. The reason for that history and the facts on which that allergy are noted will be determined. Additionally, the choice of antibiotic prophylaxis will be recorded and any adverse effect to that antibiotic noted. We will also note whether appropriate timing of the antibiotic is achieved.

Interventions

DRUGAntibiotic

Sponsors

Joseph D. Tobias
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients that are labeled as penicillin or penicillin family allergic.

Exclusion criteria

* As neurosurgical patients routinely receive vancomycin at NCH for surgical prophylaxis, they will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Number of Subjects With Antibiotic Related Adverse Event24 hours

Countries

United States

Participant flow

Participants by arm

ArmCount
Penicillin Allergy
Antibiotic
513
Total513

Baseline characteristics

CharacteristicPenicillin Allergy
Age, Categorical
<=18 years
513 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Region of Enrollment
United States
513 participants
Sex: Female, Male
Female
250 Participants
Sex: Female, Male
Male
263 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
12 / 513
serious
Total, serious adverse events
0 / 513

Outcome results

Primary

Number of Subjects With Antibiotic Related Adverse Event

Time frame: 24 hours

ArmMeasureValue (NUMBER)
Penicillin AllergyNumber of Subjects With Antibiotic Related Adverse Event12 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026