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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02036840
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : April 22, 2015
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment
Penicillin Allergy Drug: Antibiotic

Study Type : Observational
Actual Enrollment : 513 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : January 2013
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Group/Cohort Intervention/treatment
Penicillin allergy Drug: Antibiotic

Primary Outcome Measures :
  1. Number of Subjects With Antibiotic Related Adverse Event [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02036840

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

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
First Posted: January 15, 2014    Key Record Dates
Results First Posted: April 22, 2015
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents