Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis
This study has been completed.
Sponsor:
Hamad Medical Corporation
Information provided by:
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01165866
First received: July 18, 2010
Last updated: October 25, 2010
Last verified: October 2010
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Purpose
Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of persistent vomiting in patients with acute gastroenteritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroenteritis |
Drug: Treatment 1. Metoclopramide Drug: Treatment 2 Ondansetron |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Ondansetron Vs Metoclopramide in the Treatment of Vomiting in Gastroenteritis Patients: A Randomized Controlled Trial |
Resource links provided by NLM:
Drug Information available for:
Metoclopramide
Metoclopramide hydrochloride
Ondansetron hydrochloride
Ondansetron
U.S. FDA Resources
Further study details as provided by Hamad Medical Corporation:
Primary Outcome Measures:
- is the proportion of patients with cessation of vomiting after study medication administration in each group. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Time to complete cessation of vomiting, time to successful oral therapy,length of hospital stay, parents perception of the child nausea symptom and oral tolerance on discharge and daily follow up for 3 days. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Enrollment: | 170 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treatment 1.
Metoclopramide 0.3 mg/kg max 10 mg in burette and mixed with normal saline to make up 50 cc of medication and normal saline as a single intravenous dose. Complete blood count,serum electrolytes,renal function,HCO3 level will be requested.Oral fluid will be started thereafter and increased gradually until patient discharge.
|
Drug: Treatment 1. Metoclopramide
metoclopramide 0.3mg/kg maximum dose 10mg will be added in the burette and mixed with normal saline to make up 50cc of medication for intravenous administration.
Other Name: primpran
|
|
Treatment2.
Ondansetron 0.15 mg/kg max 4 mg in burette and mixed with normal saline to make up 50 cc of medication and normal saline to be given over 10 minutes,then patient will be kept NPO for one hour after completion of the anti emetic infusion and last episode of vomiting . Oral fluid will be started thereafter and increased gradually until fully tolerated and the patient is ready for discharge
|
Drug: Treatment 2 Ondansetron
Single dose of Ondansetron 0.15 mg/kg
Other Name: Zofrane
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All acute gastroenteritis patient between 1-14 years presenting to PEC Al Saad with diarrhea, persistent vomiting , fail oral rehydration and admitted to the observation unit for intravenous hydration will be eligible for the study.
Exclusion Criteria:
- Previous abdominal surgery
- Suspicion of surgical abdominal
- Bile stained vomitus
- History of hepatic and renal illnesses
- In-born error of metabolism
- Children with shock or impending shock
- Sever dehydration.
- Previous hypersensitivity or abnormal reaction to metoclopramide or ondansetron
- Antiemetic treatment within 48 hours prior to presentation.
- Seizure disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165866
Locations
| Qatar | |
| Pediatric Emergency Centre, Al-Saad | |
| Doha, Qatar | |
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
| Principal Investigator: | Khalid M Al-Ansari, FRCPC,FAAP | Hamad Medical Corporation ,Weill Cornell Medical College |
More Information
No publications provided by Hamad Medical Corporation
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Khalid M. Al Ansari, Hamad Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT01165866 History of Changes |
| Other Study ID Numbers: | 8031/08 |
| Study First Received: | July 18, 2010 |
| Last Updated: | October 25, 2010 |
| Health Authority: | Qatar: Hamad Medical Corporation |
Keywords provided by Hamad Medical Corporation:
|
Ondansetron Metoclopramide Gastroenteritis |
Additional relevant MeSH terms:
|
Gastroenteritis Vomiting Gastrointestinal Diseases Digestive System Diseases Signs and Symptoms, Digestive Signs and Symptoms Metoclopramide Ondansetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipruritics Dermatologic Agents Serotonin Antagonists Serotonin Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents |
ClinicalTrials.gov processed this record on May 19, 2013