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

CHANCHAI TRAIVAREE

Status and phase

Completed

Phase 4

Conditions

Acute Leukemic Patients in Children

Treatments

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT01094990

DEX111

PMK111 (Other Identifier)

Details and patient eligibility

About

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

Full 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?

Enrollment

32 estimated patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

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.