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Completed

NCT Number: NCT01669993

Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy

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.

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Key information

Conditions

Tonsillectomy Postoperative Adverse Events Apnea Dyssomnias Nausea Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vomiting

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3026, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Emergency Room Admissions

    Time frame: Upto 3 weeks after surgery

Secondary outcomes

  1. Postoperative Adverse Event

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 21, 2012
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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