Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

Gastroenteritis Clinical Trial

Official title:

Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02473887
• Other study ID #: 14-00030
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2015
• Last updated: June 14, 2015
• Start date: September 2014
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Qatar: Hamad Medical Corporation
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroenteritis
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ondansetron serum level.	serum level of ondansetron at 4 hours after drug administration.	4 hour	Yes
Secondary	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 ).	within one minute from drug administration.	Yes