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Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

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: NCT02473887
Recruitment Status : Completed
First Posted : June 17, 2015
Last Update Posted : June 17, 2015
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation

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 .

Condition or disease Intervention/treatment Phase
Gastroenteritis Drug: Ondansetron with1:1 ORA - sweet. Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: gastroenteritis with persistent vomiting.
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.
Drug: Ondansetron with1:1 ORA - sweet.
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.
Other Name: Zofran




Primary Outcome Measures :
  1. ondansetron serum level. [ Time Frame: 4 hour ]
    serum level of ondansetron at 4 hours after drug administration.


Secondary Outcome Measures :
  1. palatability score of the drug.score 3/5( not sure to like very much ). [ Time Frame: within one minute from drug administration. ]
    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 ).



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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473887


Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Study Chair: Khalid Al-Ansari, MD, FRCPC, FAAP Hamad Medical Corporation, Doha - Qatar
Publications:
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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT02473887    
Other Study ID Numbers: 14-00030
First Posted: June 17, 2015    Key Record Dates
Last Update Posted: June 17, 2015
Last Verified: May 2015
Keywords provided by Hamad Medical Corporation:
ondansetron
palatability
vomiting
Additional relevant MeSH terms:
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Gastroenteritis
Vomiting
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Digestive System Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents