Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis

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. Identifier: NCT01165866
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : October 26, 2010
Information provided by:
Hamad Medical Corporation

Brief Summary:
Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of persistent vomiting in patients with acute gastroenteritis.

Condition or disease Intervention/treatment Phase
Gastroenteritis Drug: Treatment 1. Metoclopramide Drug: Treatment 2 Ondansetron Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ondansetron Vs Metoclopramide in the Treatment of Vomiting in Gastroenteritis Patients: A Randomized Controlled Trial
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. is the proportion of patients with cessation of vomiting after study medication administration in each group. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  1. Previous abdominal surgery
  2. Suspicion of surgical abdominal
  3. Bile stained vomitus
  4. History of hepatic and renal illnesses
  5. In-born error of metabolism
  6. Children with shock or impending shock
  7. Sever dehydration.
  8. Previous hypersensitivity or abnormal reaction to metoclopramide or ondansetron
  9. Antiemetic treatment within 48 hours prior to presentation.
  10. Seizure disorder

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 identifier (NCT number): NCT01165866

Pediatric Emergency Centre, Al-Saad
Doha, Qatar
Sponsors and Collaborators
Hamad Medical Corporation
Principal Investigator: Khalid M Al-Ansari, FRCPC,FAAP Hamad Medical Corporation ,Weill Cornell Medical College

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Khalid M. Al Ansari, Hamad Medical Corporation Identifier: NCT01165866     History of Changes
Other Study ID Numbers: 8031/08
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: October 26, 2010
Last Verified: October 2010

Keywords provided by Hamad Medical Corporation:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents