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Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in EDs in Pakistan

Information source: University of Calgary
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dehydration; Gastroenteritis; Vomiting; Diarrhea

Intervention: Ondansetron (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sarah Williamson

Official(s) and/or principal investigator(s):
Stephen Freedman, MD, Principal Investigator, Affiliation: University of Calgary
Zulfiqar Bhutta, MD, Principal Investigator, Affiliation: Aga Khan University - World Health Organization
Sajid B Soofi, MD, Principal Investigator, Affiliation: Aga Khan University

Overall contact:
Stephen Freedman, MD, Phone: (403)955-7740, Email: stephen.freedman@albertahealthservices.ca

Summary

The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with vomiting and diarrhea in Pakistan.

Clinical Details

Official title: Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in Emergency Departments in Pakistan

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Intravenous (IV) Rehydration

Secondary outcome:

The proportion of children who vomit during the 4 hour observation period

The frequency of vomiting during the 4 hour observation period

Hospitalization > 24 hours

Volume of Oral Rehydration Solution (ORS) consumed (ml/kg) during the 4 hour observation period

Development of "SOME" dehydration during the 72 hours following randomization amongst children who are discharged

Number of diarrheal stools during the 72 hours following randomization

Treatment failure

Response based on infectious etiology (i.e. bacterial vs. viral), duration of illness (i.e. < 48 vs. ≥ 48 hours), and age (< 18 months vs. ≥ 18 months)

Detailed description: Gastroenteritis remains one of the most common causes of morbidity and mortality in children <5 years of age worldwide. A critical factor in the reduction in mortality over the past 30 years has been the introduction of oral rehydration therapy (ORT) for the treatment of dehydration. However, its use has stagnated in many low- and middle-income countries (LMIC) where many children lack access to alternatives such as intravenous (IV) rehydration. When such children have fluid losses that cannot be replaced orally due to intractable vomiting, death is common. Finding a safe, non-invasive, and effective strategy to reduce vomiting in children would substantially decrease the need for IV rehydration and hence morbidity and mortality in LMICs. Although antiemetic agents are included in the WHO list of Essential Medicines, their use in children with gastroenteritis is not endorsed by the World Health Organization (WHO). Concerns include a lack of evidence that antiemetic agents can improve outcomes and that they are associated with dangerous side effects. However, in high-income settings, studies on ondansetron, an antiemetic agent, have demonstrated that it can reduce vomiting, IV rehydration, and hospitalization. Recent reviews by prominent organizations (e. g. International child Health Review Collaboration; the Committee on the Selection and Use of Essential Medicines) have indicated an interest in ondansetron use in children with gastroenteritis, and they have concluded that further evidence is required. This trial aims to determine if the administration of a single dose of oral ondansetron results in improved outcomes in children brought for emergency department care with vomiting and diarrhea in Pakistan. Two trials will be conducted under the umbrella of one study. The proposed trials will be identical with the exception of the severity of dehydration at enrollment (either "some" or none "well"). This study will have immediate impact on patient management. Based on the results, it will be discovered if oral ondansetron plays a role in reducing the need for intravenous rehydration in children with gastroenteritis in Pakistan. As ondansetron is now available in generic formulations, and is relatively inexpensive, it is anticipated that if this study is

positive, ondansetron will be considered for inclusion in the WHO - gastroenteritis care

package. This could ultimately lead to a decrease in the need for intravenous rehydration in children in countries such as Pakistan. Moreover, these findings will lead to a subsequent study evaluating its potential benefit in outreach communities where treatments such as intravenous rehydration are unavailable.

Eligibility

Minimum age: 6 Months. Maximum age: 59 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 6 - 59 months (0. 5 - 5 years)

- Symptoms consistent with gastroenteritis (must have a & b)

a. 1 episode of nonbilious, nonbloody vomiting within the 4 hours preceding triage i. The requirement for only 1 vomiting episode is based on prior work which similarly required 1 vomiting episode within 4 hours of triage. The later study reported a 17% absolute reduction in the use of IV rehydration. The vast majority of children seeking care and enrolled in the aforementioned study had a significantly greater number of vomiting episodes in the preceding 24 hour (mean >9 episodes). b. Presence of ≥ 1 episode of diarrhea during the illness i. We require the presence of only 1 diarrheal stool to enhance our probability of enrolling children with enteritis (as opposed to other diagnoses). In fact, of the 8 RCTs performed using antiemetics in children with gastroenteritis in developed countries, only 1 even required the presence of any diarrhea as part of the eligibility criteria (and that study required a single diarrheal stool).

- Presence of NO dehydration (NO=not enough signs to classify as some or severe

dehydration) Exclusion Criteria:

- Weight <8 kg

- Vomiting or diarrhea for > 7 days

- Malnutrition: The World Health Organization (WHO) definition will be employed -

weight for height below - 3z scores of the median WHO growth standards

- Severe dehydration (WHO criteria) or hypotension defined as a systolic blood pressure

<70 mm Hg in infants 1 month to 12 months, < 70 mm Hg + (2 x age in years) in children 1-10 years, < 90 mm Hg in children ≥ 10 years

- Prior abdominal surgery (excluding hernia)

- Bilious or bloody vomitus

- Known hypersensitivity to ondansetron or any serotonin receptor antagonist

- History or family history of prolonged QT syndrome

- Taking apomorphine or any medication that is generally accepted as having a risk of

causing torsades de pointes

- Patients previously enrolled in the study

- Follow-up will not be possible

Locations and Contacts

Stephen Freedman, MD, Phone: (403)955-7740, Email: stephen.freedman@albertahealthservices.ca

Aga Khan University Hospital, Karachi, Pakistan; Recruiting
Asghar Ali, Phone: +92 21 3486 4385, Email: asghar.ali@aku.edu
Sajid Soofi, MD, Principal Investigator

Aga Khan Hospital for Women and Children (AKHWC), Kharadar, Karachi, Pakistan; Recruiting
Asghar Ali, Phone: +92 21 3486 4385, Email: asghar.ali@aku.edu
Sajid Soofi, MD, Principal Investigator

Additional Information

Starting date: May 2014
Last updated: September 25, 2014

Page last updated: August 23, 2015

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