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OpenTrials
Completed

NCT Number: NCT01094990

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

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

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Key information

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Phramongkutklao Hospital, Bangkok, Thailand

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About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

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

Primary outcomes

  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 outcomes

  1. To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone.

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

CHANCHAI TRAIVAREE

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 29, 2010
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.