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

Obstructive Sleep Apnea Syndrome Clinical Trial

— KOSATA  

Official title:

Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome After Tonsillectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425202
• Other study ID #: B2013:163
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: May 3, 2018

Study information

• Verified date: May 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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..

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Drug:
• Ketamine
Post-operative continuous infusion until 0600 the next day

Other:
• Saline infusion
Post-operative continuous infusion until 0600 the next day

Locations

Country	Name	City	State
Canada	Health Sciences Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. Clinic — View Citation

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 — View Citation

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. — View Citation

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):1108-16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients	Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients.	24 hrs
Secondary	Documentation of respiratory morbidity after tonsillectomy in OSA patients	Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients	24 hrs