NCT02512055

Brief Summary

Ketamine provides a safety zone for sedated but spontaneously ventilated children especially in remote conditions such as radiotherapy units where sedation is an essential practice for children to keep calm and motionless In this study, investigators planned to analyse ketamine doses needed and the recovery times in pediatric oncology patients undergoing repeated radiotherapy sessions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

July 24, 2015

Last Update Submit

July 28, 2015

Conditions

Conscious Sedation Failure During Procedure

Outcome Measures

Primary Outcomes (1)

  • Total ketamine consumption during each session

    peroperative 3 hours

Secondary Outcomes (1)

  • Recovery time

    peroperative 3 hours

Study Arms (1)

Group 1

EXPERIMENTAL

Pediatric patients undergoing repeat radiotherapy session under ketamine sedation

Drug: Ketamine

Interventions

KetamineDRUG

Repeated ketamine 2 mg/kg administration intravenously for sedation during each radiotherapy sessions

Also known as: Atropine
Group 1

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients undergoing radiotherapy due to oncologic disorders

You may not qualify if:

  • Patients younger than 1 year and older than 14 year,
  • patients with cardiac, renal or liver function abnormalities, who were already under sedative drug treatment or allergic to the drugs to be used or the patients for whom the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Hoffman GM, Nowakowski R, Troshynski TJ, Berens RJ, Weisman SJ. Risk reduction in pediatric procedural sedation by application of an American Academy of Pediatrics/American Society of Anesthesiologists process model. Pediatrics. 2002 Feb;109(2):236-43. doi: 10.1542/peds.109.2.236.

    PMID: 11826201BACKGROUND

  • Lois F, De Kock M. Something new about ketamine for pediatric anesthesia? Curr Opin Anaesthesiol. 2008 Jun;21(3):340-4. doi: 10.1097/ACO.0b013e3282f82bde.

    PMID: 18458551BACKGROUND

  • Macnab AJ, Levine M, Glick N, Susak L, Baker-Brown G. A research tool for measurement of recovery from sedation: the Vancouver Sedative Recovery Scale. J Pediatr Surg. 1991 Nov;26(11):1263-7. doi: 10.1016/0022-3468(91)90594-j.

    PMID: 1812252BACKGROUND

  • Tobias JD. Tolerance, withdrawal, and physical dependency after long-term sedation and analgesia of children in the pediatric intensive care unit. Crit Care Med. 2000 Jun;28(6):2122-32. doi: 10.1097/00003246-200006000-00079.

    PMID: 10890677BACKGROUND

  • Trujillo KA, Akil H. Inhibition of opiate tolerance by non-competitive N-methyl-D-aspartate receptor antagonists. Brain Res. 1994 Jan 7;633(1-2):178-88. doi: 10.1016/0006-8993(94)91538-5.

    PMID: 8137155BACKGROUND

  • Trujillo KA. The neurobiology of opiate tolerance, dependence and sensitization: mechanisms of NMDA receptor-dependent synaptic plasticity. Neurotox Res. 2002 Jun;4(4):373-91. doi: 10.1080/10298420290023954.

    PMID: 12829426BACKGROUND

  • Trujillo KA, Zamora JJ, Warmoth KP. Increased response to ketamine following treatment at long intervals: implications for intermittent use. Biol Psychiatry. 2008 Jan 15;63(2):178-83. doi: 10.1016/j.biopsych.2007.02.014. Epub 2007 Jun 13.

    PMID: 17568566BACKGROUND

  • Zapantis A, Leung S. Tolerance and withdrawal issues with sedation. Crit Care Nurs Clin North Am. 2005 Sep;17(3):211-23. doi: 10.1016/j.ccell.2005.04.011.

    PMID: 16115529BACKGROUND

MeSH Terms

Interventions

KetamineAtropine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 30, 2015

Study Start

May 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 30, 2015

Record last verified: 2015-07