Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
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ClinicalTrials.gov Identifier: NCT01094990
Recruitment Status :
First Posted : March 29, 2010
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):
CHANCHAI TRAIVAREE, Phramongkutklao College of Medicine and Hospital
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
Condition or disease
Acute Leukemic Patients in Children
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?
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Layout table for eligibility information
Ages Eligible for Study:
2 Years to 15 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.