Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati Identifier:
First received: August 17, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
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.

Tonsillectomy Postoperative Adverse Events

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing

Resource links provided by NLM:

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Immediate postoperative adverse event [ Time Frame: Post-anesthetic recovery room (PACU), an expected average of 2 hours ] [ Designated as safety issue: Yes ]
    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.

Secondary Outcome Measures:
  • Late Postoperative Adverse Event [ Time Frame: Assessed at 24 h and 3 weeks post discharge ] [ Designated as safety issue: No ]
    Assessed by electronic chart review and telephonic call to the families. The variables of interest are: Unanticipated hospital readmission, ICU admission, ER visit.

Estimated Enrollment: 2000
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing adenotonsillectomy in the United States

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01669993

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3026
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Principal Investigator: Rajeev Subramanyam, MD Children's Hospital Medical Center, Cincinnati
  More Information

Sadhasivam S CV, Ngamprasertwong P, Esslinger H, Prows C, Zhang X, Martin LJ, McAuliffe J. Pediatrics. 2012.

Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT01669993     History of Changes
Other Study ID Numbers: 2012-0273 
Study First Received: August 17, 2012
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Quality improvement
Patient Safety
Adverse events
Respiratory arrest
General Anesthesia
Obstructive sleep apnea processed this record on October 26, 2016