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

This study has been completed.
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital Identifier:
First received: January 13, 2014
Last updated: April 20, 2015
Last verified: April 2015

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.

Condition Intervention
Penicillin Allergy
Drug: Antibiotic

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Number of Subjects With Antibiotic Related Adverse Event [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 513
Study Start Date: January 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Penicillin allergy Drug: Antibiotic


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a history of allergy to penicillin who required antibiotic prophylaxis prior to/during surgery.


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.
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Please refer to this study by its identifier: NCT02036840

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joseph D. Tobias
  More Information

No publications provided

Responsible Party: Joseph D. Tobias, Chairman - Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital Identifier: NCT02036840     History of Changes
Other Study ID Numbers: IRB11-00822
Study First Received: January 13, 2014
Results First Received: February 12, 2015
Last Updated: April 20, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 06, 2015