Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis

This study has been completed.
Sponsor:
Information provided by:
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01165866
First received: July 18, 2010
Last updated: October 25, 2010
Last verified: October 2010
  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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014