NCT02425202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2018

Completed
Last Updated

October 15, 2018

Status Verified

May 1, 2018

Enrollment Period

3.4 years

First QC Date

April 14, 2015

Last Update Submit

October 12, 2018

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

pediatricobstructive sleep apneatonsillectomyanalgesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Documentation of respiratory morbidity after tonsillectomy in OSA patients

    24 hrs

Study Arms (2)

Ketamine infusion

ACTIVE COMPARATOR

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

Drug: Ketamine

Saline infusion

PLACEBO COMPARATOR

Saline infusion

Other: Saline infusion

Interventions

KetamineDRUG

Post-operative continuous infusion until 0600 the next day

Also known as: Ketalar
Ketamine infusion
Saline infusionOTHER

Post-operative continuous infusion until 0600 the next day

Also known as: Placebo comparator
Saline infusion

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Center

Winnipeg, Manitoba, R3A 1S1, Canada

Location

Related Publications (5)

  • 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.

    PMID: 21539679RESULT

  • 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.

    PMID: 23905822RESULT

  • 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.

    PMID: 20448096RESULT

  • 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.

    PMID: 14500166RESULT

  • 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.

    PMID: 21493257RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAgnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Harley Wong, MD, FRCPC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 23, 2015

Study Start

December 1, 2014

Primary Completion

May 3, 2018

Study Completion

May 3, 2018

Last Updated

October 15, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)