Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients
Verified August 2014 by Nationwide Children's Hospital
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
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.
||Observational Model: Case-Only
Time Perspective: Retrospective
Primary Outcome Measures:
- Number of subjects with antibiotic related adverse event [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with a history of allergy to penicillin who required antibiotic prophylaxis prior to/during surgery.
- Patients that are labeled as penicillin or penicillin family allergic.
- As neurosurgical patients routinely receive vancomycin at NCH for surgical prophylaxis, they will be excluded from the study.
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 ClinicalTrials.gov identifier: NCT02036840
|Nationwide Children's Hospital
|Columbus, Ohio, United States, 43205 |
|Sub-Investigator: Ralph Beltran, MD |
Joseph D. Tobias
No publications provided
||Joseph D. Tobias, Chairman - Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 13, 2014
||August 16, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 27, 2014