Clinical trial NCT01669993: Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy
Official title: Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsillectomy Postoperative Adverse Events
Keywords: Outcomes
Quality improvement
Patient Safety
PACU
Complications
Adverse events
Respiratory arrest
Pain
PONV
Age
Neonate
Infant
Child
Ambulatory
Inpatient
General Anesthesia
Otolaryngology
Tonsillectomy
Obstructive sleep apnea
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 2400
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing adenotonsillectomy in the United States

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.

Eligibility criteria: 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

Primary outcomes:
measure: Emergency Room Admissions
timeFrame: Upto 3 weeks after surgery
Secondary outcomes:
measure: Postoperative Adverse Event
timeFrame: Assessed in post anesthesia care unit
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Rajeev Subramanyam, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Subramanyam R, Willging P, Ding L, Yang G, Varughese A. Factors Associated With Postadenotonsillectomy Unexpected Admissions in Children. Anesth Analg. 2021 Jun 1;132(6):1700-1709. doi: 10.1213/ANE.0000000000005123.