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Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy

Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01669993
Enrollment
2400
Registered
2012-08-21
Start date
2012-05-31
Completion date
2017-11-30
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Emergency Room AdmissionsUpto 3 weeks after surgery

Secondary

MeasureTime frameDescription
Postoperative Adverse EventAssessed in post anesthesia care unitThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026