Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in EDs in Pakistan (OWEP)
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ClinicalTrials.gov Identifier: NCT01870635 |
Recruitment Status
:
Completed
First Posted
: June 6, 2013
Last Update Posted
: March 2, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dehydration Gastroenteritis Vomiting Diarrhea | Drug: Ondansetron Drug: Placebo | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 625 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Ondansetron Administration to WELL Children With Gastroenteritis Associated Vomiting in Emergency Departments in Pakistan |
Actual Study Start Date : | May 2014 |
Actual Primary Completion Date : | January 20, 2017 |
Actual Study Completion Date : | February 3, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Ondansetron
4 mg oral disintegrating tablet of ondansetron Participant weight 8-15 kg = half dose (2mg) Participant weight greater than 15 kg = full dose (4mg) |
Drug: Ondansetron
Eligible children will receive one weight based (0.13 - 0.26 mg/kg) dose of an oral ondansetron disintegrating tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
Other Name: Zofran
|
Placebo Comparator: Placebo (sugar pill) |
Drug: Placebo
Eligible children will receive one dose of an oral disintegrating Placebo (sugar pill) tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
Other Name: Sugar Pill
|
- Intravenous (IV) Rehydration [ Time Frame: within 72 hours of randomization ]IV rehydration is defined as the IV administration of ≥20 ml/kg over 4 hours of an isotonic fluid for the purpose of rehydration within 72 hours of randomization. This definition allows for the occurrence of the primary outcome in children who receive maintenance plus replacement of losses and not simply those who receive a fluid bolus. This will not include those who simply receive maintenance fluids (e.g. 4 ml/kg/hr for those weighing < 10 kg). This will also enable us to exclude children who undergo IV insertion for the purpose of medication administration. IV rehydration is a powerful marker of treatment failure, a decrease in which is likely to impact practice and influence decision makers since it is drastically more expensive that ORT, it is painful and is associated with a greater risk of adverse events.
- The proportion of children who vomit during the 4 hour observation period [ Time Frame: within 4 hour observation period after randomization ]
- The frequency of vomiting during the 4 hour observation period [ Time Frame: within 4 hour observation period after randomization ]
- Hospitalization > 24 hours [ Time Frame: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment ]Total length of stay from Emergency Department (ED) arrival until discharge of > 24 hours, regardless of whether time is spent in the ED or inpatient unit
- Volume of Oral Rehydration Solution (ORS) consumed (ml/kg) during the 4 hour observation period [ Time Frame: within 4 hour observation period after randomization ]
- Development of "SOME" dehydration during the 72 hours following randomization amongst children who are discharged [ Time Frame: within 72 hours of randomization ]
All children will be presumed to not be dehydrated at the time of discharge regardless of severity of dehydration at the time of ED presentation.
SOME Dehydration = 2 or more of the following signs:
- Restlessness, irritability
- Sunken Eyes
- Drinks eagerly, thirsty
- Skin pinch goes back slowly
- Number of diarrheal stools during the 72 hours following randomization [ Time Frame: within 72 hours of randomization ]Diarrheal stools are defined, in keeping with the WHO definition as "loose or liquid stools"
- Treatment failure [ Time Frame: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment ]
This aggregate outcome will include children who experience the following:
- IV rehydration as defined in primary outcome
- Nasogastric rehydration for > 24 hours - this implies a failure of outpatient Oral Rehydration Therapy (ORT)
- Death within 72 hours (from any cause; in or out of hospital)
- 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) [ Time Frame: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment ]
- Major Side Effects [ Time Frame: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment ]Uncommon events such as: Arrythmia and Death. This data is critical to estimate a safety profile of ondansetron in low to middle income countries
- Semi- and Intensive Care Unit Admission [ Time Frame: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment ]This data is critical to estimate a safety profile of ondansetron in low to middle income countries

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Ages Eligible for Study: | 6 Months to 59 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 6 - 59 months (0.5 - 5 years)
-
Symptoms consistent with gastroenteritis (must have a & b)
- 1 episode of nonbilious, nonbloody vomiting within the 4 hours preceding triage 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).
- Presence of ≥ 1 episode of diarrhea during the illness 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

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 ClinicalTrials.gov identifier (NCT number): NCT01870635
Pakistan | |
Aga Khan University Hospital | |
Karachi, Pakistan | |
Aga Khan Hospital for Women and Children (AKHWC) | |
Kharadar, Karachi, Pakistan |
Principal Investigator: | Stephen Freedman, MD | University of Calgary | |
Principal Investigator: | Zulfiqar Bhutta, MD | Aga Khan University - World Health Organization | |
Principal Investigator: | Sajid B Soofi, MD | Aga Khan University |
Responsible Party: | Dr. Stephen Freedman, Associate Professor of Pediatrics; Alberta Children's Hospital Foundation Professor in Child Health and Wellness Alberta Children's Hospital Theme Lead, University of Calgary |
ClinicalTrials.gov Identifier: | NCT01870635 History of Changes |
Other Study ID Numbers: |
RSO1026252 |
First Posted: | June 6, 2013 Key Record Dates |
Last Update Posted: | March 2, 2018 |
Last Verified: | February 2018 |
Keywords provided by Dr. Stephen Freedman, University of Calgary:
Low-middle income country Dehydration Intravenous Rehydration Pakistan |
Additional relevant MeSH terms:
Vomiting Diarrhea Gastroenteritis Dehydration Signs and Symptoms, Digestive Signs and Symptoms Gastrointestinal Diseases Digestive System Diseases Water-Electrolyte Imbalance Metabolic Diseases Pathologic Processes Ondansetron Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipruritics 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 |