Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
NCT ID: NCT02473887
Last Updated: 2015-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2014-09-30
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department
NCT00120744
Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial
NCT04318847
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
NCT00691275
The Effect of Ondansetron During Intramuscular Ketamine Use in Children: A Trial in Emergency Department
NCT01477242
Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis
NCT01165866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* acute simple gastroenteritis with mild to moderate dehydration.
* more than 2 episodes of vomiting in 24 hours period.
Exclusion Criteria
* seizure disorder.
* chronic liver or kidney diseases.
* on any chronic medication.
3 Years
8 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hamad Medical Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Khalid Al-Ansari, MD, FRCPC, FAAP
Role: STUDY_CHAIR
Hamad Medical Corporation, Doha - Qatar
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14-00030
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.