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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01094990
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : January 11, 2012
Sponsor:
Information provided by (Responsible Party):
CHANCHAI TRAIVAREE, Phramongkutklao College of Medicine and Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Acute Leukemic Patients in Children Drug: Dexamethasone Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Dexamethasone for The Prevention of Nausea and Vomiting Associated With Intrathecal Chemotherapy and Ketamine Sedation in Children With Leukemia
Study Start Date : April 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

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Arms and Interventions
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Intervention Details:
  • Drug: Dexamethasone
    dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time

Outcome Measures
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Primary Outcome Measures :
  1. : To determine whether vomiting and retching associated with intravenous ketamine and intrathecal chemotherapy may be reduced by the addition of prophylactic dexamethasone [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone. [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094990


Locations
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Thailand
Phramongkutklao hospital
Bangkok, Thailand, 10400
Phramongkutklao Hospital
Bangkok, Thailand
Sponsors and Collaborators
CHANCHAI TRAIVAREE
Investigators
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Principal Investigator: chanchai traivaree, MD Phramongkutklao College of Medicine and Hospital
More Information
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Responsible Party: CHANCHAI TRAIVAREE, Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier: NCT01094990    
Other Study ID Numbers: DEX111
PMK111 ( Other Identifier: Pharmongkutklao )
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012
Keywords provided by CHANCHAI TRAIVAREE, Phramongkutklao College of Medicine and Hospital:
crossover; double blinded; intrathecal chemotherapy; dexamethasone; ketamine;vomiting
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents