- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01094990
Efficacy of Dexamethasone for Prevent Vomiting in Leukemic Children Who Receive Intrathecal Chemotherapy
January 9, 2012 updated by: CHANCHAI TRAIVAREE
Efficacy of Dexamethasone for The Prevention of Nausea and Vomiting Associated With Intrathecal Chemotherapy and Ketamine Sedation in Children With Leukemia
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10400
- Phramongkutklao Hospital
-
Bangkok, Thailand
- Phramongkutklao Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
: 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
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether severity of the nausea after procedure may be reduced by the addition of prophylactic dexamethasone.
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: chanchai traivaree, MD, Phramongkutklao College of Medicine and Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
March 26, 2010
First Submitted That Met QC Criteria
March 26, 2010
First Posted (Estimate)
March 29, 2010
Study Record Updates
Last Update Posted (Estimate)
January 11, 2012
Last Update Submitted That Met QC Criteria
January 9, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Vomiting
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- DEX111
- PMK111 (Other Identifier: Pharmongkutklao)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Leukemic Patients in Children
-
Assiut UniversityNot yet recruitingPossibility of Using microRNA30a as a Prognostic Marker in Philadelphia Positive Leukemic Patients by Measure Level of microRNA30a in Blood Sample
-
Princess Maxima Center for Pediatric OncologyEuropean CommissionRecruitingAcute Myeloid Leukemia in ChildrenNetherlands
-
Washington University School of MedicineRecruitingAcute Myeloid Leukemia in ChildrenUnited States
-
Princess Maxima Center for Pediatric OncologyDaiichi SankyoRecruitingAcute Myeloid Leukemia in ChildrenNetherlands
-
Sunshine Lake Pharma Co., Ltd.Completed
-
Hopital LariboisièreCompletedAcute Medical Patients Hospitalized in Internal Medicine
-
Recep Tayyip Erdogan University Training and Research...CompletedDental Caries in Children | Radiology | Pediatric PatientsTurkey
-
MendusCompletedAcute Myeloid Leukemia (AML) | Leukemic Dendritic Cell VaccinationNetherlands
-
Novartis PharmaceuticalsCompletedProphilaxis of Acute Rejection in Patients Receiving a Renal AllograftSpain
-
Alexandria UniversityUnknownLeukemic Patients With Increased Intracranial Pressure | Optic Nerve Sheath FenestrationEgypt
Clinical Trials on Dexamethasone
-
Ottawa Hospital Research InstituteCompletedPain Syndrome | Early-stage Breast CancerCanada
-
Centre hospitalier de l'Université de Montréal...CompletedPrevention of Hypersensitivity Reactions to PaclitaxelCanada
-
Universidade Federal de PernambucoCompletedDiabetic Macular EdemaBrazil
-
Shanghai Jiao Tong University Affiliated Sixth...CompletedAnalgesia | Time | Brachial Plexus Block | Shoulder Surgery | Dexamethasone | Intravenous Drug UsageChina
-
Vanderbilt University Medical CenterTerminatedAsthma | CroupUnited States
-
Dr. Stephen ChoiThe Physicians' Services Incorporated FoundationCompletedShoulder Surgery | Nerve BlockCanada
-
Universitätsklinikum Hamburg-EppendorfGemeinsamer Bundesausschuss (G-BA); Staburo GmbHRecruiting
-
Poznan University of Medical SciencesRecruitingWrist Injuries | Hand Injuries | Hand Injuries and Disorders | Hand Disease | Wrist DiseasePoland
-
University of California, San FranciscoCompletedOral Lichen Planus | Pemphigus Vulgaris | Mucous Membrane Pemphigoid | Chronic Graft-versus-host-diseaseUnited States
-
University of BelgradeCompleted