Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis
Condition: Gastroenteritis
MeSH terms: Gastroenteritis; Vomiting
Study type: Interventional
Phase: Phase 4

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

Detailed description: 
      In this study, we will compare the efficacy of a single intravenous dose of ondansetron
      versus intravenous metoclopramide in the treatment of persistent vomiting in simple
      gastroenteritis in a larger RCT.

      PEC Al Saad is the main Pediatric Emergency Center in the state of Qatar with approximately
      200,000 visits annually. It has a capacity of 42 observation beds providing most of the
      inpatient facilities except for intensive care monitoring. Patients admitted to the PEC are
      managed there for 48 hours or longer if needed, they are then transferred to Hamad General
      Hospital for further investigation and completion of their treatment. Hamad General Hospital
      is the main tertiary care hospital in Qatar with a capacity of around 100 pediatric beds.

      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.

      Patients were excluded from the study if they had one or more of the following: Previous
      abdominal surgery,Suspicion of surgical abdominal,Bile stained vomitus,History of hepatic
      illness,Metabolic diseases, including diabetes mellitus and in-born error of
      metabolism,Children with shock or impending shock,Sever dehydration,Previous hypersensitivity
      or abnormal reaction to metoclopramide or ondansetron,Parenteral antiemetic treatment in the
      previous 24hrs or Seizure disorder

      One group will receive a single IV dose of Ondansetron after enrollment and the second group
      will receive a single IV dose of Metoclopramide On arrival to the PEC, patients with simple
      gastroenteritis will be assessed by the pediatric specialist on-call, patients with
      persistent vomiting who fail ORS therapy will be admitted for observation and management as
      usual. The pediatric specialist in the observation room will take history, perform full
      physical examination and evaluate the degree of dehydration . Patients will be assessed for
      eligibility to the study based on the aforementioned inclusion criteria.

      Guardians of eligible patients will be approached regarding the study, explaining the purpose
      and the treatment modalities, patients will be included after obtaining a verbal and written
      consent. Complete blood count, serum electrolytes, renal function, HCO3 level will be
      requested for all study patients upon recruitment.

      The observation physician will complete the data collection sheet that will include the
      patient's demographics, physical examination, degree of dehydrations , number, amount and
      time of every vomiting and diarrhea episode and lab work results.

      Intravenous Ondansetron and intravenous metoclopramide treatment will be prepared by a
      pharmacist, who will put each treatment in a sealed coded envelope A and B depending on the
      content (Ondansetron or Metoclopramide). The code of intervention package will be deposited
      with the pharmacist. The medical team in addition to the patients will be blinded to the
      content of the envelopes. There will be no detectable difference in the color or smell of the
      different solutions, the amount of medication will be determined by the weight of the patient
      (Ondansetron 0.15mg/kg maximum dose 4mg, Metoclopramide 0.3 mg/kg maximum dose 10mg),
      medication will be added in the buret and mixed with normal saline to make up 50cc of
      medication and normal saline for intravenous administration.

      Patients will receive a single intravenous dose of the study medication after enrollment over
      10 minutes and intravenous fluids will be started at the rate required based on the
      percentage of dehydration. Patients will be kept NPO for one hour after the completion of the
      antiemetic infusion and last episode of vomiting, oral fluids will be started thereafter and
      increased gradually until fully tolerated and the patient is ready for discharge. If vomiting
      recur NPO period will be extended for another half an hour from the last vomit and oral
      fluids will be tried gradually until the patient is fit for discharge. Vomiting and diarrhea
      episodes will be recorded by time and amount throughout admission.

      Duration of IV fluid therapy needed, observed study medication side effects all will be
      recorded until the patient is ready for discharge if extra-pyramidal side effect are seen or
      suspected diphen hydramine 1 mg/kg (maximum dose 50mg/dose) will be given over 5 minutes and
      the patient will be observed until free of symptoms. Addition interventions such as
      antibiotics, antipyretics will be recorded as additional therapies.

      The treating physician will discharge patients based on clinical grounds such as tolerating
      oral fluids, improve hydration status, absent of significant fluid loss through stool and
      free of major medication side effects. Patients found to be fit for discharge, will have date
      and time of discharge documented. In addition parents will be asked to give a number ,that
      represent their perception of their child's nausea symptoms and oral intake improvement on
      discharge, 0-100, 0 indicates no improvement and 100 back to base line.

      Discharge Patients will be sent home on oral fluid therapy and BRAT diet. All patients will
      be followed up for 72 hours post discharge by a phone call daily.
    

Intervention name(s): Treatment 1. Metoclopramide; Treatment 2 Ondansetron
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Single dose of Ondansetron 0.15 mg/kg
Other intervention name(s): primpran; Zofrane
Intervention MeSH terms: Ondansetron; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ondansetron; Metoclopramide; Gastroenteritis