Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis

NCT01165866 | Completed Phase 4 DMC

• 1 other identifier: 8031/08
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroenteritis

Keywords

Ondansetron; Metoclopramide; Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• is the proportion of patients with cessation of vomiting after study medication administration in each group.

  one year

Secondary Outcomes (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.

  one year

Study Arms (2)

Treatment 1.

ACTIVE COMPARATOR

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

Treatment2.

OTHER

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

Interventions

Treatment 1. Metoclopramide DRUG

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.

Also known as: primpran

Treatment 1.

Treatment 2 Ondansetron DRUG

Single dose of Ondansetron 0.15 mg/kg

Also known as: Zofrane

Treatment2.

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Pediatric Emergency Centre, Al-Saad

Doha, Qatar

Location

Related Publications (1)

• Al-Ansari K, Alomary S, Abdulateef H, Alshawagfa M, Kamal K. Metoclopramide versus ondansetron for the treatment of vomiting in children with acute gastroenteritis. J Pediatr Gastroenterol Nutr. 2011 Aug;53(2):156-60. doi: 10.1097/MPG.0b013e3182132d8d.

  PMID: 21788756 DERIVED

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Khalid M Al-Ansari, FRCPC,FAAP

  Hamad Medical Corporation ,Weill Cornell Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2010
• First Posted: July 20, 2010
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 26, 2010

Record last verified: 2010-10

Locations

QA (1)