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

Phase 4

Completed

• Conditions: Acute Leukemic Patients in Children

• Registration Number: NCT01094990
• Lead Sponsor: CHANCHAI TRAIVAREE

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?

Study Timeline

• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Study Start: 2011-04
• Primary Completion: 2011-09
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
: 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 Outcome Measures

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

Trial Locations

Locations (2)

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand

Phramongkutklao hospital; 🇹🇭 Bangkok, Thailand