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

Acute Leukemic Patients in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094990
• Other study ID #: DEX111
• Secondary ID: PMK111
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2010
• Last updated: January 9, 2012
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Leukemic Patients in Children
• Vomiting

Intervention

Drug:
• Dexamethasone
dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time

Locations

Country	Name	City	State
Thailand	Phramongkutklao hospital	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
CHANCHAI TRAIVAREE

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	: To determine whether vomiting and retching associated with intravenous ketamine and intrathecal chemotherapy may be reduced by the addition of prophylactic dexamethasone		24 hours	Yes
Secondary	To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone.		24 hours	Yes