Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

NCT02174874 | Completed

• 1 other identifier: OND - 0001
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• proportion of patients who vomit within 15 minutes of administration of anti-emetic

  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.

  15 minutes

Secondary Outcomes (2)

• # episodes of vomiting after ondansetron administration

  While in the ED, anticipated to be on average < 5 hours

• Discharged home without IV

  Duration of ED visit, anticipated to be on average < 5 hours

Study Arms (2)

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

Eligibility Criteria

• Age: 3 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Graham Thompson: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: June 26, 2014
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2014
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

CA (1)