search
Back to results

Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

Primary Purpose

Gastroenteritis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Ondansetron with1:1 ORA - sweet.
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis focused on measuring ondansetron, palatability, vomiting

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children 3-8 years of age.
  • acute simple gastroenteritis with mild to moderate dehydration.
  • more than 2 episodes of vomiting in 24 hours period.

Exclusion Criteria:

  • known hypersensitivity to ondansetron.
  • seizure disorder.
  • chronic liver or kidney diseases.
  • on any chronic medication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    gastroenteritis with persistent vomiting.

    Arm Description

    patients with gastroenteritis with persistent vomiting received single dose of intravenous ondansetron form orally after being flavored with 1:1 ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight.

    Outcomes

    Primary Outcome Measures

    ondansetron serum level.
    serum level of ondansetron at 4 hours after drug administration.

    Secondary Outcome Measures

    palatability score of the drug.score 3/5( not sure to like very much ).
    Palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. score 3/5( not sure to like very much ).

    Full Information

    First Posted
    May 25, 2015
    Last Updated
    June 14, 2015
    Sponsor
    Hamad Medical Corporation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02473887
    Brief Title
    Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
    Official Title
    Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hamad Medical Corporation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to give children with gastroenteritis with persistent vomiting flavored intravenous ondansetron orally. The investigators test the palatability of the drug and check the serum level of ondansetron at 4 hours .
    Detailed Description
    This is a prospective pilot study for children,3-8 years of age presented to the Pediatric Emergency Department in the state of Qatar between September 2014 and January 2015, with acute gastroenteritis with mild to moderate dehydration, more than 2 episodes of vomiting in the last 24 hours, and who had failed oral rehydration trial in the department as per the department oral hydration protocol. Acute gastroenteritis was defined as diarrhea and vomiting for less than a week period. Hydration level was assessed for all patients on arrival, and eligible patients were enrolled after obtaining an informed written consent.Enrolled patients received intravenous ondansetron form orally after being flavored 1:1 with ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight. Palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. All patients were kept nil per oral for 30 minutes and then oral rehydration trial was started as per the department rehydration protocol. If the drug was vomited within 30 min of administration, a similar second dose was given. Blood level for ondansetron was collected 4 hours after the successful drug administration and was sent to the department laboratory within 5 min. Patients were sent home when they were ready for discharge as per the treating physician discretion. All patients were followed by a telephone call after 24 hours to assess the safety and efficacy of the orally taken ondansetron.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroenteritis
    Keywords
    ondansetron, palatability, vomiting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    gastroenteritis with persistent vomiting.
    Arm Type
    Experimental
    Arm Description
    patients with gastroenteritis with persistent vomiting received single dose of intravenous ondansetron form orally after being flavored with 1:1 ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight.
    Intervention Type
    Drug
    Intervention Name(s)
    Ondansetron with1:1 ORA - sweet.
    Other Intervention Name(s)
    Zofran
    Intervention Description
    single dose of intravenous ondansetron form orally after being flavored with 1:1 ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight.
    Primary Outcome Measure Information:
    Title
    ondansetron serum level.
    Description
    serum level of ondansetron at 4 hours after drug administration.
    Time Frame
    4 hour
    Secondary Outcome Measure Information:
    Title
    palatability score of the drug.score 3/5( not sure to like very much ).
    Description
    Palatability was evaluated by the primary investigator within one minute fom drug administration applying taste scores for children and recorded according to a specific scoring system. score 3/5( not sure to like very much ).
    Time Frame
    within one minute from drug administration.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    8 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children 3-8 years of age. acute simple gastroenteritis with mild to moderate dehydration. more than 2 episodes of vomiting in 24 hours period. Exclusion Criteria: known hypersensitivity to ondansetron. seizure disorder. chronic liver or kidney diseases. on any chronic medication.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khalid Al-Ansari, MD, FRCPC, FAAP
    Organizational Affiliation
    Hamad Medical Corporation, Doha - Qatar
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16625009
    Citation
    Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
    Results Reference
    background
    PubMed Identifier
    18762604
    Citation
    DeCamp LR, Byerley JS, Doshi N, Steiner MJ. Use of antiemetic agents in acute gastroenteritis: a systematic review and meta-analysis. Arch Pediatr Adolesc Med. 2008 Sep;162(9):858-65. doi: 10.1001/archpedi.162.9.858.
    Results Reference
    background
    PubMed Identifier
    22344213
    Citation
    Sturm JJ, Pierzchala A, Simon HK, Hirsh DA. Ondansetron use in the pediatric emergency room for diagnoses other than acute gastroenteritis. Pediatr Emerg Care. 2012 Mar;28(3):247-50. doi: 10.1097/PEC.0b013e3182494d87.
    Results Reference
    background
    PubMed Identifier
    10710025
    Citation
    Angelilli ML, Toscani M, Matsui DM, Rieder MJ. Palatability of oral antibiotics among children in an urban primary care center. Arch Pediatr Adolesc Med. 2000 Mar;154(3):267-70. doi: 10.1001/archpedi.154.3.267.
    Results Reference
    background

    Learn more about this trial

    Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

    We'll reach out to this number within 24 hrs