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Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

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: NCT02174874
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Graham Thompson, Alberta Children's Hospital

Tracking Information
First Submitted Date May 26, 2011
First Posted Date June 26, 2014
Last Update Posted Date June 26, 2014
Study Start Date June 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2014)
proportion of patients who vomit within 15 minutes of administration of anti-emetic [ Time Frame: 15 minutes ]
To determine the proportion of patients aged 3 months to 10 years who present to the PED with recent significant vomiting and moderate dehydration who vomit within 15 minutes of receiving either Ondansetron Oral Solution versus Orally Disintegrating Tablets.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 24, 2014)
  • # episodes of vomiting after ondansetron administration [ Time Frame: While in the ED, anticipated to be on average < 5 hours ]
    To determine the number of episodes of vomiting while in the emergency department (after Ondansetron administration) that are experienced by the above population.
  • Discharged home without IV [ Time Frame: Duration of ED visit, anticipated to be on average < 5 hours ]
    To determine the proportions of children in each study group that are discharged home from the Emergency Department without receiving IV fluids.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)
Official Title Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department
Brief Summary In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.
Detailed Description Vomiting related to viral gastroenteritis is the most common presentation to the Alberta Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. Administration of an antiemetic, Ondansetron, is an integral part of improving the hydration status of children managed by the pathway. However it is not know whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who have active vomiting. The investigators aim to show that children receiving Oral Disintegrating Tablets have less vomiting immediately after medication administration than children receiving Oral Solution. By demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing Ondansetron Oral Disintegrating Tablets into their practice for children with active vomiting.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis
Condition Acute Gastroenteritis
Intervention Not Provided
Study Groups/Cohorts
  • Oral Ondansetron
    Arm that receive oral solution .8 mgms per ml ondansetron - Apotex Brand DIN 02291967
  • Oral disintegrating tablets
    Arm that receives the disintegrating tablets either 4mg or 8 mgs Glaxo Brand 4 mg DIN 02239372, 8 mg DIN 02239373
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 24, 2014)
462
Original Actual Enrollment Same as current
Actual Study Completion Date June 2014
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children aged 3 months to 10 years with recent,
  • significant vomiting and moderate dehydration who are managed according to the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting & Diarrhea Pathway.
  • The following definitions are used to determine inclusion according to the pathway: Recent, significant vomiting - Vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; Moderate dehydration (Gorelick Score 2) - Two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance.

Exclusion Criteria:

  • Children who are excluded from the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting & Diarrhea Pathway.
  • These criteria include: Vomiting or Diarrhea for greater than 7 days, Localized abdominal pain, Chronic medical conditions affecting major organ systems (Ex, diabetes, PKU, immunodeficiency), Likely GI Obstruction (abdominal distension, bilious vomiting, absent bowel sounds), Weight less than 8kg. Children who have received anti-emetics at home will not be excluded but will be tracked.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Months to 10 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02174874
Other Study ID Numbers OND - 0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Graham Thompson, Alberta Children's Hospital
Study Sponsor Dr. Graham Thompson
Collaborators Not Provided
Investigators
Principal Investigator: Graham Thompson, Physician Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
Principal Investigator: David W Johnson, Physician Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
PRS Account Alberta Children's Hospital
Verification Date June 2014