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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Ketamine

Saline infusion

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring pediatric, obstructive sleep apnea, tonsillectomy, analgesia

Eligibility Criteria

1 Year - 17 Years (Child)All SexesAccepts Healthy Volunteers

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..

Sites / Locations

Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketamine infusion

Saline infusion

Arm Description

Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr

Saline infusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Documentation of respiratory morbidity after tonsillectomy in OSA patients

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

Full Information

NCT ID

NCT02425202

First Posted

April 14, 2015

Last Updated

October 12, 2018

Sponsor

University of Manitoba

1. Study Identification

Unique Protocol Identification Number

NCT02425202

Brief Title

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

Acronym

KOSATA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

May 3, 2018 (Actual)

Study Completion Date

May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Manitoba

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea Syndrome

Keywords

pediatric, obstructive sleep apnea, tonsillectomy, analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketamine infusion

Arm Type

Active Comparator

Arm Description

Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr

Arm Title

Saline infusion

Arm Type

Placebo Comparator

Arm Description

Saline infusion

Intervention Type

Drug

Intervention Name(s)

Ketamine

Other Intervention Name(s)

Ketalar

Intervention Description

Post-operative continuous infusion until 0600 the next day

Intervention Type

Other

Intervention Name(s)

Saline infusion

Other Intervention Name(s)

Placebo comparator

Intervention Description

Post-operative continuous infusion until 0600 the next day

Primary Outcome Measure Information:

Title

Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients

Description

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

Time Frame

24 hrs

Secondary Outcome Measure Information:

Title

Documentation of respiratory morbidity after tonsillectomy in OSA patients

Description

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

Time Frame

24 hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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..

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harley Wong, MD, FRCPC

Organizational Affiliation

University of Manitoba

Official's Role

Principal Investigator

Facility Information:

Facility Name

Health Sciences Center

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1S1

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21539679

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.

Results Reference

result

PubMed Identifier

23905822

Citation

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.

Results Reference

result

PubMed Identifier

20448096

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 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.

Results Reference

result

PubMed Identifier

14500166

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):1108-1116. doi: 10.1213/01.ANE.0000081061.12235.55.

Results Reference

result

PubMed Identifier

21493257

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. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.

Results Reference

result

Learn more about this trial

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

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