Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Nationwide Children's Hospital
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital Identifier:
First received: January 13, 2014
Last updated: August 16, 2014
Last verified: August 2014

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 ]

Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02036840

Contact: Julie Rice, RN 614-355-3142
Contact: N'Diris Barry, RN 614-355-3467

United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Sub-Investigator: Ralph Beltran, MD         
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
Last Updated: August 16, 2014
Health Authority: United States: Institutional Review Board processed this record on February 27, 2015