Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
2 other identifiers
interventional
32
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2011
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 29, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 11, 2012
January 1, 2012
5 months
March 26, 2010
January 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
: 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 (1)
To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone.
24 hours
Interventions
dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Phramongkutklao hospital
Bangkok, Bangkok, 10400, Thailand
Phramongkutklao Hospital
Bangkok, Bangkok, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
chanchai traivaree, MD
Phramongkutklao College of Medicine and Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Phramongkutklao College of Medicine and Hospital
Study Record Dates
First Submitted
March 26, 2010
First Posted
March 29, 2010
Study Start
April 1, 2011
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
January 11, 2012
Record last verified: 2012-01