Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome (OSAS) After Tonsillectomy (KOSATA)

• ClinicalTrials.gov Identifier: NCT02425202
• Recruitment Status: Completed
• First Posted: April 23, 2015
• Last Update Posted: October 15, 2018
• Sponsor: University of Manitoba
• Information provided by (Responsible Party): University of Manitoba

Tracking Information

• First Submitted Date: April 14, 2015
• First Posted Date: April 23, 2015
• Last Update Posted Date: October 15, 2018
• Study Start Date: December 2014
• Actual Primary Completion Date: May 3, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 20, 2015)

Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients [ Time Frame: 24 hrs ]

Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 20, 2015)

Documentation of respiratory morbidity after tonsillectomy in OSA patients [ Time Frame: 24 hrs ]

Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome (OSAS) After Tonsillectomy
• Official Title: Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome After Tonsillectomy: A Randomized Controlled Trial
• Brief Summary: The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.
• Detailed Description: Eligible pediatric patients that are undergoing tonsillectomy for sleep-disordered breathing or obstructive sleep apnea AND are to be admitted into a monitored setting will be recruited for this study. They will be randomized into two groups:1) Control group receiving continuous infusion of saline (placebo) and 2) Study group receiving continuous infusion of low-dose ketamine at 0.1 mg/kg/hr. Both patients will receive scheduled oral acetaminophen and rescue intravenous morphine as required. The infusions will be stopped at 0600 the next morning. Morphine requirements, pain scores at selected times, central nervous system side effects, and adverse cardiorespiratory events will be recorded.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obstructive Sleep Apnea Syndrome

Intervention

• Drug: Ketamine
  Post-operative continuous infusion until 0600 the next day
  Other Name: Ketalar
• Other: Saline infusion
  Post-operative continuous infusion until 0600 the next day
  Other Name: Placebo comparator

Study Arms

• Active Comparator: Ketamine infusion
  Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr
  Intervention: Drug: Ketamine
• Placebo Comparator: Saline infusion
  Saline infusion
  Intervention: Other: Saline infusion

Publications *

• 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. Review.
• Alexander NS, Schroeder JW Jr. Pediatric obstructive sleep apnea syndrome. Pediatr Clin North Am. 2013 Aug;60(4):827-40. doi: 10.1016/j.pcl.2013.04.009. Review.
• Bhattacharjee R, Kheirandish-Gozal L, Spruyt K, Mitchell RB, Promchiarak J, Simakajornboon N, Kaditis AG, Splaingard D, Splaingard M, Brooks LJ, Marcus CL, Sin S, Arens R, Verhulst SL, Gozal D. Adenotonsillectomy outcomes in treatment of obstructive sleep apnea in children: a multicenter retrospective study. Am J Respir Crit Care Med. 2010 Sep 1;182(5):676-83. doi: 10.1164/rccm.200912-1930OC. Epub 2010 May 6.
• Petrenko AB, Yamakura T, Baba H, Shimoji K. The role of N-methyl-D-aspartate (NMDA) receptors in pain: a review. Anesth Analg. 2003 Oct;97(4):1108-1116. doi: 10.1213/01.ANE.0000081061.12235.55. Review.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 12, 2018): 36
• Original Estimated Enrollment (submitted: April 20, 2015): 72
• Actual Study Completion Date: May 3, 2018
• Actual Primary Completion Date: May 3, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients requiring tonsillectomy for diagnosis of sleep disordered breathing/obstructive sleep apnea that will be admitted for overnight cardiorespiratory monitoring, based on positive polysomnography test, positive nocturnal home oximetry, or strong signs/symptoms of OSAS

Exclusion Criteria:

• Patients with significant developmental delay, abnormal airway anatomy, significant co-morbidities such as cardiac disorders, respiratory disorders, neurological disorders, anad renal disorders.
• Previous reaction to study medications.
• Postoperative bleeding within the first 24 hours
• Refusal to be involved in the study..

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02425202
• Other Study ID Numbers: B2013:163
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Manitoba
• Study Sponsor: University of Manitoba
• Collaborators: Not Provided

Investigators

• Principal Investigator: Harley Wong, MD, FRCPC; University of Manitoba

• PRS Account: University of Manitoba
• Verification Date: May 2018