Evidence map›Paper›PMID 30392735›Full record

ArticleAnnals of emergency medicine2019

Oral Ondansetron Administration to Nondehydrated Children With Diarrhea and Associated Vomiting in Emergency Departments in Pakistan: A Randomized Controlled Trial.

Stephen B Freedman, Sajid B Soofi, Andrew R Willan, Sarah Williamson-Urquhart, Noshad Ali, Jianling Xie, Fady Dawoud, Zulfiqar A Bhutta

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Annals of emergency medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Observational
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Stephen B FreedmanSection of Pediatric Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Section of Pediatric Gastroenterology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Paediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. Electronic address: stephen.freedman@ahs.ca.
Sajid B SoofiCentre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.
Andrew R WillanOntario Child Health Support Unit, Sickkids Research Institute, Toronto, Ontario, Canada.
Sarah Williamson-UrquhartSection of Pediatric Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Noshad AliCentre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.
Jianling XieSection of Pediatric Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Fady DawoudSection of Pediatric Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Zulfiqar A BhuttaCentre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan; Centre for Global Child Health, The Hospital for Sick Children, Toronto, Ontario, Canada.
University of Calgary · CAAga Khan University · PKSickKids Foundation · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectiveWe determine whether single-dose oral ondansetron administration to children with vomiting as a result of acute gastroenteritis without dehydration reduces administration of intravenous fluid rehydration.

methodsIn this 2-hospital, double-blind, placebo-controlled, emergency department-based, randomized trial conducted in Karachi Pakistan, we recruited children aged 0.5 to 5.0 years, without dehydration, who had diarrhea and greater than or equal to 1 episode of vomiting within 4 hours of arrival. Patients were randomly assigned (1:1), through an Internet-based randomization service using a stratified variable-block randomization scheme, to single-dose oral ondansetron or placebo. The primary endpoint was intravenous rehydration (administration of ≥20 mL/kg of an isotonic fluid during 4 hours) within 72 hours of randomization.

resultsParticipant median age was 15 months (interquartile range 10 to 26) and 59.4% (372/626) were male patients. Intravenous rehydration use was 12.1% (38/314) and 11.9% (37/312) in the placebo and ondansetron groups, respectively (odds ratio 0.98; 95% confidence interval [CI] 0.60 to 1.61; difference 0.2%; 95% CI of the difference -4.9% to 5.4%). Bolus fluid administration occurred within 72 hours of randomization in 10.8% (34/314) and 10.3% (27/312) of children administered placebo and ondansetron, respectively (odds ratio 0.95; 95% CI 0.56 to 1.59). A multivariable regression model fitted with treatment group and adjusted for antiemetic administration, antibiotics, zinc prerandomization, and vomiting frequency prerandomization yielded similar results (odds ratio 0.91; 95% CI 0.55 to 1.53). There was no interaction between treatment group and age, greater than or equal to 3 stools in the preceding 24 hours, or greater than or equal to 3 vomiting episodes in the preceding 24 hours.

conclusionOral administration of a single dose of ondansetron did not result in a reduction in intravenous rehydration use. In children without dehydration, ondansetron does not improve clinical outcomes.

Indexed as

Administration, OralAntiemeticsChild, PreschoolDehydrationDiarrheaDouble-Blind MethodEmergency Service, HospitalFemaleFluid TherapyHumansInfantMaleOndansetronPakistanTreatment OutcomeVomitingAntiemeticsOndansetron

Identifiers

PMID30392735
PMCPMC6390170
OpenAlexW2899379546

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.