Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy

Completed

• Conditions: Tonsillectomy Postoperative Adverse Events

• Registration Number: NCT01669993
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-21
• Primary Completion: 2017-06
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

• Children 0-17 years of age
• Children scheduled for tonsillectomy or adeno-tonsillectomy
• ASA I, II, or III

Exclusion Criteria

• ASA IV and V

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Emergency Room Admissions	Upto 3 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative Adverse Event	Assessed in post anesthesia care unit	This will be measured in post anesthesia care unit (PACU) and will be a composite measure of any one or a combination of these: desaturation, somnolence, laryngospasm /airway obstruction, airway instrumentation, drug administration, PACU discharge criteria not met, unanticipated hospital or ICU admission.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States