Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01669993
Brief Summary:
The purposes of the study are to identify 1) the patient (demographic and clinical) and health care system factors predictive of immediate and late postoperative adverse outcomes in children undergoing tonsillectomy. 2) Evaluate the preoperative use of the sleep questionnaire to identify children at risk for immediate and late postoperative adverse outcomes in children undergoing tonsillectomy.
Detailed Description:
Currently, children are scheduled to go home or stay in the hospital depending on expert consensus and institutional guidelines. The investigators preliminary experience (Dr. Sadhasivam PI: IRB No. 2008-0848) with the pharmocogenetic study, studying the phenotypic and genotypic influences of pain and use of opioids in patients undergoing tonsillectomy indicates that a significant number of patients scheduled as outpatients experience prolonged recovery phases in the PACU, some of whom are admitted or re-admitted following discharge. The identification of those factors that are, predictive of adverse events in tonsillectomy patients and the development of a prototype prediction model in this single-center study to support clinical decision-making. The rationale of this project is that developing a model to predict postoperative adverse events will not only lead to improved clinical outcomes and enhance patient safety, but also reduce family psychosocial distress associated with unanticipated hospital visits or re-admission, while reducing the burden on the health care system.
Study:
NCT01669993
Study Brief:
Protocol Section:
NCT01669993