Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
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
Intervention / Treatment
-
Dexamethasone (DRUG)dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time
Condition or Disease
- Acute Leukemic Patients in Children
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 2 Years to 15 Years |
| Enrollment: | 32 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Prevention |
MaskingQUADRUPLE:
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Clinical Trial Dates
| Start date: | Apr 01, 2011 | |
|---|---|---|
| Primary Completion: | Sep 01, 2011 | ACTUAL |
| Completion Date: | Dec 01, 2011 | ACTUAL |
| Study First Posted: | Mar 29, 2010 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jan 09, 2012 |
Sponsors / Collaborators
Lead Sponsor:
CHANCHAI TRAIVAREE
Responsible Party:
CHANCHAI TRAIVAREE
Location
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?
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 2 |
| Maximum Age: | 15 |
| Age Groups: | Child |
| Healthy Volunteers: | Yes |
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.
* 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.
Primary Outcomes
-
: 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 Outcomes
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To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone. 24 hours
More Details
| NCT Number: | NCT01094990 |
|---|---|
| Other IDs: | DEX111 |
| Study URL: | https://clinicaltrials.gov/study/NCT01094990 |
Last updated: Sep 29, 2023