Trial | NCT01094990  Report issue

Title

Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
Efficacy of Dexamethasone for The Prevention of Nausea and Vomiting Associated With Intrathecal Chemotherapy and Ketamine Sedation in Children With Leukemia

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea ...

  • Study Participants

    32
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
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?
Study Started
Apr 30
2011
Primary Completion
Sep 30
2011
Study Completion
Dec 31
2011
Last Update
Jan 11
2012
Estimate

Drug Dexamethasone

dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time

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.
No Results Posted