Efficacy of Dexamethasone for Prevent Vomiting in Leukemi... | NCT01094990

Studies
Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy

NCT01094990

Sponsor

CHANCHAI TRAIVAREE

Status

Completed

Last Update Posted

Jan 11, 2012Estimated

Enrollment

32Estimated

Phase

Phase 4

Conditions

Acute Leukemic Patients in Children

Interventions

Dexamethasone

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PMK111	Other Identifier	Pharmongkutklao

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 26, 2010

First Submission Date that Met QC Criteria

Mar 26, 2010

First Posted Date

Mar 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2012

Last Update Posted Date

Jan 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

CHANCHAI TRAIVAREE, Phramongkutklao College of Medicine and Hospital, Phramongkutklao College of Medicine and HospitalSponsor-Investigator

Lead Sponsor

CHANCHAI TRAIVAREEOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Null hypothesis The proportions of vomiting are not different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy Alternative hypothesis The proportions of vomiting are different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy

Detailed Description

Does intravenous dexamethasone 0.25 mg/kg (8 mg/m2/dose) have an effect in the reduction of vomiting and retching after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy comparison with placebo?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
: To determine whether vomiting and retching associated with intravenous ketamine and intrathecal chemotherapy may be reduced by the addition of prophylactic dexamethasone		24 hours

Secondary Outcomes

Measure	Description	Time Frame
To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone.		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged between 2-15 years who underlying acute lymphoid or nonlymphoid leukemia and need to receive ketamine and intrathecal chemotherapy.
Personally signed and dated informed consent and assent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study entry.

Exclusion Criteria:

Patients who had a known allergy to ketamine or dexamethasone.
Patients who had contraindication for ketamine or dexemethasone such as hypertension, increased intracranial pressure or central nervous system mass lesion, major psychiatric , and hyperglycemia.
Patients who concurrent with nausea and vomiting during that time.
Patients who received ondansetron or other antiemetic before doing Procedure.
Patients who received other chemotherapy before or after 24 hours.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
chanchai traivaree, MD	Phramongkutklao College of Medicine and Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Phramongkutklao hospital		Bangkok	Bangkok	10400	Thailand
Phramongkutklao Hospital

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

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