Factors Predictive of Adverse Postoperative Outcomes in Children Undergoing Tonsillectomy
NCT ID: NCT01669993
Last Updated: 2018-01-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
2400 participants
Study Classification
OBSERVATIONAL
Study Start Date
2012-05-31
Study Completion Date
2017-11-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Tonsillectomy Postoperative Adverse Events
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Children 0-17 years of age
* Children scheduled for tonsillectomy or adeno-tonsillectomy
* ASA I, II, or III
* Children scheduled for tonsillectomy or adeno-tonsillectomy
* ASA I, II, or III
Exclusion Criteria
* ASA IV and V
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Rajeev Subramanyam, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Site Status
Countries
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United States
References
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Jaryszak EM, Lander L, Patel AK, Choi SS, Shah RK. Prolonged recovery after out-patient pediatric adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2011 Apr;75(4):585-8. doi: 10.1016/j.ijporl.2011.01.024. Epub 2011 Feb 15.
Reference Type
BACKGROUND
Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.
Reference Type
BACKGROUND
Morris LG, Lieberman SM, Reitzen SD, Edelstein DR, Ziff DJ, Katz A, Komisar A. Characteristics and outcomes of malpractice claims after tonsillectomy. Otolaryngol Head Neck Surg. 2008 Mar;138(3):315-20. doi: 10.1016/j.otohns.2007.11.024.
Reference Type
BACKGROUND
Stevenson AN, Myer CM 3rd, Shuler MD, Singer PS. Complications and legal outcomes of tonsillectomy malpractice claims. Laryngoscope. 2012 Jan;122(1):71-4. doi: 10.1002/lary.22438. Epub 2011 Nov 10.
Reference Type
BACKGROUND
Richmond KH, Wetmore RF, Baranak CC. Postoperative complications following tonsillectomy and adenoidectomy--who is at risk? Int J Pediatr Otorhinolaryngol. 1987 Aug;13(2):117-24. doi: 10.1016/0165-5876(87)90088-7.
Reference Type
BACKGROUND
Raghavendran S, Bagry H, Detheux G, Zhang X, Brouillette RT, Brown KA. An anesthetic management protocol to decrease respiratory complications after adenotonsillectomy in children with severe sleep apnea. Anesth Analg. 2010 Apr 1;110(4):1093-101. doi: 10.1213/ANE.0b013e3181cfc435. Epub 2010 Feb 8.
Reference Type
BACKGROUND
Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.
Reference Type
BACKGROUND
Boss EF, Marsteller JA, Simon AE. Outpatient tonsillectomy in children: demographic and geographic variation in the United States, 2006. J Pediatr. 2012 May;160(5):814-9. doi: 10.1016/j.jpeds.2011.11.041. Epub 2011 Dec 17.
Reference Type
BACKGROUND
Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.
Reference Type
BACKGROUND
Audit NP. Impact of NICE guidance on rates of haemorrhage after tonsillectomy: an evaluation of guidance issued during an ongoing national tonsillectomy audit. Qual Saf Health Care. 2008 Aug;17(4):264-8. doi: 10.1136/qshc.2006.021386.
Reference Type
BACKGROUND
Zhao YC, Berkowitz RG. Prolonged hospitalization following tonsillectomy in healthy children. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1885-9. doi: 10.1016/j.ijporl.2006.06.015. Epub 2006 Aug 17.
Reference Type
BACKGROUND
Mitchell RB, Kelly J. Behavior, neurocognition and quality-of-life in children with sleep-disordered breathing. Int J Pediatr Otorhinolaryngol. 2006 Mar;70(3):395-406. doi: 10.1016/j.ijporl.2005.10.020.
Reference Type
BACKGROUND
Tunkel DE. Polysomnography before tonsillectomy in children: who and when? Otolaryngol Head Neck Surg. 2012 Feb;146(2):191-3; discussion 194-5. doi: 10.1177/0194599811429236. Epub 2011 Nov 16.
Reference Type
BACKGROUND
Chervin RD, Weatherly RA, Garetz SL, Ruzicka DL, Giordani BJ, Hodges EK, Dillon JE, Guire KE. Pediatric sleep questionnaire: prediction of sleep apnea and outcomes. Arch Otolaryngol Head Neck Surg. 2007 Mar;133(3):216-22. doi: 10.1001/archotol.133.3.216.
Reference Type
BACKGROUND
Shapiro NL, Seid AB, Pransky SM, Kearns DB, Magit AE, Silva P. Adenotonsillectomy in the very young patient: cost analysis of two methods of postoperative care. Int J Pediatr Otorhinolaryngol. 1999 May 5;48(2):109-15. doi: 10.1016/s0165-5876(99)00011-7.
Reference Type
BACKGROUND
Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.
Reference Type
BACKGROUND
Varughese AM, Morillo-Delerme J, Kurth CD. Quality management in the delivery of pediatric anesthesia care. Int Anesthesiol Clin. 2006 Winter;44(1):119-39. doi: 10.1097/01.aia.0000196253.46033.f9. No abstract available.
Reference Type
BACKGROUND
Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008 Aug;107(2):413-21. doi: 10.1213/ane.0b013e31817e616b.
Reference Type
BACKGROUND
Brigger MT, Brietzke SE. Outpatient tonsillectomy in children: a systematic review. Otolaryngol Head Neck Surg. 2006 Jul;135(1):1-7. doi: 10.1016/j.otohns.2006.02.036.
Reference Type
BACKGROUND
Raeder J. Ambulatory anesthesia aspects for tonsillectomy and abrasion in children. Curr Opin Anaesthesiol. 2011 Dec;24(6):620-6. doi: 10.1097/ACO.0b013e32834b9482.
Reference Type
BACKGROUND
Sadhasivam S, Chidambaran V, Ngamprasertwong P, Esslinger HR, Prows C, Zhang X, Martin LJ, McAuliffe J. Race and unequal burden of perioperative pain and opioid related adverse effects in children. Pediatrics. 2012 May;129(5):832-8. doi: 10.1542/peds.2011-2607. Epub 2012 Apr 23.
Reference Type
BACKGROUND
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.
Reference Type
DERIVED
Other Identifiers
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2012-0273
Identifier Type: -
Identifier Source: org_study_id
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