European Journal of Pediatrics

https://doi.org/10.1007/s00431-020-03680-x

REVIEW

Effect of ondansetron on vomiting associated with acute

gastroenteritis in a developing country: a meta-analysis
Hai-lin Wu 1 & Xue Zhan 1

Received: 2 March 2020 / Revised: 6 May 2020 / Accepted: 8 May 2020

# Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract
In high-income countries. ondansetron is an effective antiemetic in children with gastroenteritis, but data from low- and middle-
income countries are sparse. This study aimed to evaluate evidences of the effectiveness of ondansetron in preventing vomiting
and reducing the use of intravenous fluids in children with gastroenteritis in developing countries. A total of nine randomized
controlled trials (RCTs) involving 2313 participants met the inclusion criteria. Compared with placebo, ondansetron reduced the
use of intravenous rehydration (three RCTs, n = 1126, relative risk (RR) 0.60, 95% confidence interval (CI) 0.38–0.95, no
significant heterogeneity, I2 = 43%), the risk of failure of oral rehydration therapy among children with gastroenteritis-associated
vomiting and dehydration (four RCTs, n = 1370, RR 0.58, 95% CI 0.43–0.79; no significant heterogeneity was found, I2 = 39%)
and risk of hospitalization (2 RCTs, n = 264, RR 0.25, 95% CI 0.09–0.73, no heterogeneity, I2 = 0).
Conclusions: Compared with placebo, ondansetron reduced the use of intravenous fluids in children with gastroenteritis and
dehydration. It has no effect on children with gastroenteritis who do not present with dehydration in developing countries. While
ondansetron is effective in controlling vomiting and reducing the rate of hospitalization, there is no evidence that it is effective in
reducing the rate of readmission.

What is Known:
• In high-income countries, ondansetron can reduce the use of intravenous fluids in children with gastroenteritis and dehydration.
• No systematic review and meta-analysis of randomized controlled trials were done in a developing country setting.
What is New:
• In developing countries, ondansetron reduces the use of intravenous fluids in children with gastroenteritis and dehydration.
• It has no effect on children with gastroenteritis but without dehydration.

Keywords Child . Dehydration . Gastroenteritis . Ondansetron . Vomiting

Abbreviations ORT Oral rehydration therapy

RCT Randomized controlled trial AGE Acute gastroenteritis
IV Intravenous RR Relative risk
CI Confidence interval
Communicated by Peter de Winter

* Xue Zhan
zhanxue@hotmail.com
Hai-lin Wu
Whlmt123456@163.com
1
Department of Gastroenterology, Ministry of Education Key
Laboratory of Child Development and Disorders; National Clinical
Research Center for Child Health and Disorders; China International
Science and Technology Cooperation base of Child development and
Critical Disorders; Children’s Hospital of Chongqing Medical
University, Chongqing, P.R China., Chongqing Key Laboratory of
Pediatrics, No.136, Zhongshan 2nd Road, Yuzhong District,
Chongqing 400014, China
Introduction
Acute gastroenteritis (AGE) is the leading cause of child mor-
tality and morbidity worldwide, especially in developing
countries. According to the latest report, approximately
550,000 children aged < 5 years died of AGE each year [1].
Vomiting accounts for the highest percentage because of un-
successful oral rehydration therapy and is one of the common
symptoms of AGE.
Increasing numbers of recent clinical trials in high-income
countries have shown that children with AGE benefit from

using ondansetron [2–4]. Meanwhile, many institutions prefer
to prescribe ondansetron over other antiemetic drugs in the
management of acute childhood gastroenteritis in emergency
departments [5]. However, only a few studies were specifical-
ly designed to evaluate the use of ondansetron in children with
AGE from developing countries, which has the highest con-
tribution to the incidence rate.
In 2016, a systematic review [6] investigated the effective-
ness of ondansetron in the treatment and prevention of AGE in
children and showed that ondansetron improved the efficacy
of oral rehydration therapy. However, instead of reviewing
data from developing countries exclusively, the systematic
review included data of all countries despite the difference in
etiologies, clinical phenotypes, and complications between
developed and developing countries [7, 8]. In addition, con-
tradictory evidence on ondansetron has been published since
then. For example, according to a randomized controlled trial
(RCT) performed in Pakistan, ondansetron had no effect on
reducing the use of intravenous rehydration in children with-
out dehydration. Therefore, the present study aimed to system-
atically evaluate evidence on the effectiveness of ondansetron
in reducing the use of intravenous fluid and vomiting in chil-
dren with gastroenteritis in developing countries.
Materials and methods
This systematic review and meta-analysis follow the
Cochrane Collaboration guidelines in undertaking this review
[9] and the PRISMA statement with respect to reporting [10].
Ethical approval was not needed to perform this systematic
review.
Inclusion criteria
The inclusion criteria were as follows: only RCTs testing the
effects of ondansetron for the treatment or prevention of
vomiting in developing countries [11], infants and children
up to 18 years of age, included trials used ondansetron regard-
less of formula or dose, and participants in the control group
received placebo or no intervention. The outcomes were as
follows: cessation of vomiting, hospitalization, return visit to
emergency department, need for intravenous rehydration, and
failure of ORT. The definitions used by the investigators for
all outcomes were accepted. Additionally, adverse events
were analyzed.
Literature search
We searched Medline, EMBASE, and the Cochrane Library
databases from database inception to February 2020 without
language restriction. The principal search words were as fol-
lows: antiemetics, ondansetron, Zofran, vomiting, emesis,
Eur J Pediatr
gastroenteritis, diarrhea, dehydration, pediatric, child, infant,
toddler, and randomized. We also manually searched bibliog-
raphies of papers of interest and relevant meeting abstracts via
the International Conference to obtain additional references.
Collection of data and analysis
The reviewers undertook the literature search, extraction of
data, and quality assessment using a standardized form. Data
extracted by one reviewer included baseline characteristics,
eligibility criteria, dose of the intervention, experimental and
control treatments, and study setting. Other reviewers checked
all identified studies.
Assessment of risk of bias in included studies
We applied the Cochrane Collaboration tool to assess the risk
of bias of the included RCTs. Our assessment items included
methods of randomization (selection bias), allocation conceal-
ment (selection bias), blinding of participants and personnel
(performance bias), blinding of outcome assessment (detec-
tion bias), and incomplete outcome data (attrition bias).
Additionally, another bias (defined as industry support) was
also considered [12].
Assessment of heterogeneity and of reporting biases
Heterogeneity was quantified by χ2 and I2. For χ2, a P < 0.10
indicated statistical significance for heterogeneity. I2 = 0%
indicated no observed heterogeneity. I2 ≥ 50% indicated sig-
nificant heterogeneity. All analyses were based on the
random-effects model. We planned to assess the publication
bias using the funnel plot proposed by Egger et al. However,
the small number of included studies did not allow this test.
Data synthesis
Data were analyzed using the Review Manager (RevMan)
version 5.3 (Copenhagen: The Nordic Cochrane Centre, The
Cochrane Collaboration, 2014). For the primary outcomes, we
planned to perform subgroup analyses including the observa-
tion time after medication and evidence of dehydration in
participants.
Results
A flow diagram documenting the identification process of
eligible trials is shown in Fig. 1. Detailed characteristics of
included RCTs are presented in Table 1. Nine RCTs that ran-
domized 2313 participants (1158 in the experimental group
and 1155 in the control group) aged 3 months to 12 years were
identified. The sample size in all included trials ranged from
Eur J Pediatr

Records identiied Additional records

through database identiied through the route of administration showed a reduction in vomiting
searching hand-searching
(n=2172) (n=0)
with oral administration of ondansetron (1 RCT [21], n =
918, RR 1.17, 95% CI 1.10–1.25), but not with intravenous
Records after duplicates
administration (2 RCTs [17, 19], n = 331, RR 1.18, 95% CI
removed 0.94–1.48). However, no difference was found between the
(n=1532)
groups in terms of vomiting cessation both at 24 h after treat-
Records
excluded,with ment administration (3RCTs [15, 18, 19], n = 288, RR 3.18,
reasons(n=1507): 95% CI 0.85 to 5.58, high heterogeneity, I2 = 91%) and after
-study type(N=1463)
-brief items(n=12)
48 h after treatment administration (1 RCT [17], n = 176, RR
-intervention(not 1.15, 95% CI 0.92–1.44). At 24 h after treatment administra-
Ondansetron)(n=23) tion, subgroup analysis based on the route of administration
Records screened
(n=1532) -participants(not
children)(n=9)
showed a reduction in vomiting with oral administration of
ondansetron (1 RCT [18], n = 109, RR 3.21, 95% CI 2.07–
Full-text articles
excluded,with
4.98), but not with intravenous administration (2 RCTs [15,
Full-text articles reasons(n=16): 19], n = 179, RR 1.67, 95% CI 0.58–4.78)
assessed for -study type(N=3)
eligibility
-intervention(N=5)
(n=25)
-state type(N=8) Failure of oral rehydration therapy
Studies included
in qualitative Four RCTs (n = 1370) [13, 17, 18, 21] showed a reduction in
synthesis
(n=9)
the risk of failure of oral rehydration therapy in children with
dehydration treated with ondansetron compared with those
Studies included treated with placebo (RR 0.58, 95% CI 0.43–0.79; no signif-
in quantitative
synthesis
icant heterogeneity was found, I2 = 39%) (Fig. 4). For children
(meta-analysis) without dehydration, no difference in the risk of failure of oral
(n=9)
rehydration was found between the groups (1RCT [20], n =
626, RR 0.95, 95% CI 0.60 to 1.50).
Fig. 1 Flow chart for search results. From “Effect of ondansetron for
vomiting associated with acute gastroenteritis in a developing country:
a meta-analysis” Intravenous rehydration

24 to 918 participants. Included trials were carried out in
countries such as India (1 RCT) [13], Vietnam (1 RCT)
[14], Venezuela (1 RCT) [15], Thailand (1 RCT) [16], Iran
(1 RCT) [17], Turkey (2 RCTs) [18, 19], and Pakistan (2
RCTs) [20, 21]. The doses of ondansetron ranged from
0.13–0.15 mg/kg to 2–3 mg/kg; meanwhile, the administra-
tion routes were intravenous and oral. High risk of bias was
observed for at least one of the domains in the majority of the
studies (see Fig. 2 and Table 2).
Compared with placebo or no intervention, the use of
ondansetron significantly reduced the risk of the need for in-
travenous rehydration in children who were already
dehydrated before intervention (3 RCTs [13, 14, 21], n =
1126, RR 0.60, 95% CI 0.38–0.95, no significant heterogene-
ity, I2 = 43%) (Fig. 4). However, for undehydrated children,
no significant difference was found between the groups
(1RCT, n = 626 [20], RR 0.98, 95% CI 0.64–1.50).

Hospitalization
Cessation of vomiting
Two RCTs reported this outcome. Ondansetron significantly
Eight RCTs mentioned this outcome [13–19, 21, 22], but their
decreased the risk of hospitalization when compared with pla-
observation times varied (Fig. 3). Compared with the placebo
cebo (2 RCTs [18, 19], n = 264, RR 0.25, 95% CI 0.09–0.73,
or no intervention group, the ondansetron group has signifi-
no heterogeneity, I2 = 0) (Fig. 4).
cantly higher chance for vomiting cessation after the admin-
istration of the first dose (2RCTs [14, 16], n = 135, relative
risk (RR) 3.30, confidence interval (CI) 2.11 to 5.16, no het- Return visit to emergency department
erogeneity, I2 = 0), 4 h after treatment administration (3 RCTs
[17, 19, 21], n = 1249, RR 1.17, 95% CI 1.05–1.30, high Two trials [16, 18] (n = 251) reported no difference between
heterogeneity, I2 = 64%), and 8 h after treatment administra- the groups in terms of return visits to the emergency depart-
tion (1RCT [18], n = 109, RR 2.35, 95% CI 1.57 to 3.51). At ment (RR 0.92, 95% CI 0.50–1.69, no heterogeneity, I2 = 0)
4 h after treatment administration, subgroup analysis based on (Fig. 4).
Table 1 Study characteristics. From “Effect of ondansetron for vomiting associated with acute gastroenteritis in a developing country: a meta-analysis”

Study ID; country Participants Intervention ondansetron Comparison Inclusion criteria Main outcome measures
(exp/cont) (dose; method)

1. RANG 2019; 30/31 0.2 mg/kg (maximum of mg) An equal volume of 0.9% 11–60 months: acute diarrhea (> 3 Vomiting episodes, ORS intake, diarrhea episodes, duration of
Vietnam Intravenously saline solution; stools in 24 h): mild to moderate diarrheal symptoms, hospital stay
Intravenously dehydration
2. CUBEDDU 1997; 12/12 0.3 mg/kg An equal volume of sterile 6 months–8 years acute gastroen- Emetic episodes, diarrheal episodes
Venezuela Intravenously saline; teritis
Intravenously
3. Freedman 2019; 462/456 8–15 kg:2 mg; 15 kg:4 mg Identical placebo Orally 6 months–5 years: ≥ 8.0 kg; ≥ epi- Intravenous rehydration, the presence and frequency of vomiting
Pakistan Orally sode of diarrhea during the 4-h observation period, hospitalization for 24 h, ORS
intake
4. Danewa 2016; 85/85 0.2 mg/kg Identical placebo 3 months–5 years; Failure of ORT, administration of unscheduled intravenous fluids,
India Orally Orally acute diarrhea (duration < 14 days) amount of ORS intake in 4 h
with some dehydration
5. Freedman 2019; 312/314 8–15 kg; 2 mg; > 15 kg; 4 mg The placebo 0.5 to 5.0 years gastroenteritis(≥ 1 Intravenous rehydration, the presence and frequency of vomiting,
Pakistan Orally episode of vomiting within the 4 hospitalization; volume of oral rehydration solution, presence of
h), no evidence of dehydration some dehydration number of diarrhea, stools, treatment failure
6. Goishekan 2013; 88/88 < 15 kg:2 mg:15–30 kg:4 mg Placebo tablets 1 to10 years: acute gastroenteritis Vomiting episodes, require intravenous, rehydration therapy,
Iran > 30 kg:6 mg (at least one episode of vomiting hospitalized
Orally in previous 6 h); dehydration
7. Rerksuppaphol 37/37 0.15 mg/kg Normal 0.9% saline solution 3 months to 15 years acute The number of vomiting episodes the volume of intravenous and oral
2010; Thailand Intravenously gastroenteritis (vomited more rehydration fluid, length of hospital stay
than three times in the 24 h)
8. YILMAZ 2010; 55/54 0.2 mg/kg (0.2 mL/kg) Placebo Acute gastroenteritis (vomit at least The frequency of emesis the rates of intravenous fluid administration
Turke Orally 4 times in the last 6 h) or admission to hospital, toleration of ORT, weight gain and
mild-to-moderate dehydration frequency of diarrhea
9. Karakayali 2019; 77/78 0.15 mg/kg 100 mL normal saline 1–18 years vomiting Recurrence of vomiting after 60 min subsequent to antiemetic
Turkey Intravenously therapy
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Eur J Pediatr

Fig. 2 Assessment of
methodological quality of
randomized trials. From “Effect
of ondansetron for vomiting
associated with acute
gastroenteritis in a developing
country: a meta-analysis

Amount of oral rehydration solution intake Adverse events and side effects

The included articles provided data regarding the amount of
oral rehydration solution (ORS) intake in different outcome
measures; therefore, we report the results in a narrative format.
Three RCTs [13, 16, 21] reported the amount of ORS intake at
different time intervals with different outcomes measures. One
RCT [13] compared ondansetron with placebo and found an
increase in ORS intake within 4 h (median 91.3 mL/4 h, 95%
CI 35.0–147.6). (MD 91.3 mL/4 h, 95% CI 35.0–147.6). Two
RCTs showed no significant differences between the
ondansetron and placebo groups within 4 h [21] (median 4.2
vs 3.8 mL/kg/h, P > 0.99) or during the observation period
[16] (1.9 ± 1.7 vs. 1.3 ± 1.0 mL/kg/h, P = 0.15).
The nine trials did not record cardiovascular, respiratory, and
other adverse events. However, six studies [14, 15, 18–21]
reported about adverse events. In three of them [19–21], no
significant differences were found in the adverse events be-
tween the study groups. In the remaining three trials [14, 15,
18], some complications such as drowsiness, cough, and diar-
rhea were reported in the ondansetron group. In these trials,
one RCT [14] reported that one patient had excessive sweat-
ing after ondansetron administration, while the blood glucose
test result was in normal range. One RCT [15] had mentioned
that three patients (25%) in the ondansetron group developed
symptoms of cough compared with one patient (8%) in the

Table 2 Assessment of methodological quality of randomized trials. From “Effect of ondansetron for vomiting associated with acute gastroenteritis in
a developing country: a meta-analysis”

Fig. 3 Ondansetron vs. placebo
for cessation of vomiting in
children with acute
gastroenteritis. From “Effect of
ondansetron for vomiting
associated with acute
gastroenteritis in a developing
country: a meta-analysis”. IV,
intravenous
matched group. In the remaining RCT [18], one patient who
experienced abdominal distention and oral rehydration thera-
py failure was hospitalized. Although previous studies sug-
gested that ondansetron may have increased the risk of diar-
rhea and the incidence of diarrhea, some have different opin-
ions between these trials. Of the eight trials, only one [18] trial
had clearly shown that the frequency of diarrhea in children
taking ondansetron was higher (P = 0.04). Furthermore, two
trails [13, 17] especially pointed out that diarrhea episodes did
not increase in the ondansetron group.
Discussion
This meta-analysis of RCTs revealed that ondansetron, when
compared with placebo or no intervention, reduced the risk of
failure of oral rehydration therapy and the use of intravenous
rehydration in children with gastroenteritis-associated
vomiting and dehydration. However, it had no significant ef-
fect on children without dehydration. In addition, ondansetron
reduced the risk of hospitalization, but it had no significant
effect on the need for return visits to the emergency
Eur J Pediatr
department. As regards vomiting cessation, our meta-
analysis provides evidence that ondansetron could be useful
in reducing emesis associated with AGE in developing coun-
tries. No difference was found between the groups after 24 and
48 h. The lack of an effect after 24 and 48 h seems to be caused
by self-limitation of AGE. Adverse events were rarely ob-
served, or rates were similar in both study groups. It was not
possible to sufficiently estimate the frequency of adverse
events due to the inconsistencies in the reporting of adverse
events and complications. However, three studies [13, 16, 17]
had not recorded any adverse events, but some previous stud-
ies reported side effects. The most common adverse reaction is
the aggravation of diarrhea [6]. In addition, ondansetron was
associated with QT prolongation and severe cardiac arrhyth-
mias [23–25]. However, no severe adverse reactions were
observed in the included studies and it is controversial wheth-
er diarrhea is an adverse reaction. It would be helpful to report
adverse events more clearly in future studies.
The effectiveness of ondansetron in developed countries
has already been reported. Nevertheless, this has never been
addressed by a systematic review of RCTs in a developing
country. This study systematically analyzed relevant
Eur J Pediatr

Fig. 4 Ondansetron vs. placebo

for failure of ORT, intravenous
rehydration, hospitalization, and
return visit to emergency
department in children with
dehydration or without
dehydration. From “Effect of
ondansetron for vomiting
associated with acute
gastroenteritis in a developing
country: a meta-analysis”

information in developing countries. Furthermore, one RCT
of this meta-analysis specifically excluded children with de-
hydration to focus on the effects of ondansetron in low-risk
populations.
However, our review still has several important limitations.
First, only a small number of studies were available. Second,
unclear or high risk of bias in some of the included trials poses
a question regarding the reliability of the reported findings.
Third, given the small number of trials available, significant
heterogeneity between studies can only be partially explained
by methodological differences in study design. Different clin-
ical factors likely contribute to this observed heterogeneity as
well. In future investigations, it might be possible to use a
precise and universal standard [26]. However, given the small
number of studies, meta-analyses in subgroups were not
performed. Fourth, vomiting and dehydration have varied def-
initions. Fifth, although other outcomes were evaluated by the
authors of the original trials, all their results could not be
pooled in a meta-analysis because some outcomes were based
on different statistics, only one study reported these outcomes,
and the observation time intervals varied. Finally, some out-
comes such as the amount of diarrhea and amount of ORS
intake were evaluated in only a subset of trials with a limited
number of participants.
Although compared with the 16-year meta-analysis [6], the
results of the present study included only RCTS in developing
countries, but similar results were obtained, such as hospital-
ization, return visit to the emergency department, need for
intravenous rehydration, and failure of ORT. This may indi-
cate that ondansetron is also applicable to the management of

children with AGE treated in developing countries. However,
more research is needed to confirm this conclusion.
Conclusions
Based on our meta-analysis, in developing countries, the use
of ondansetron is beneficial to children with AGE and dehy-
dration, whereas its use does not show additional benefit to
children who do not present dehydration.
Authors’ contributions Hai-Lin Wu initially conceptualized this study.
Both authors were responsible for data collection, analysis, interpretation,
and preparation of the report. Hai-Lin Wu assumed the primary respon-
sibility for the writing of this manuscript. Both authors agreed upon the
final version of the article. Hai-Lin Wu is a guarantor.
Compliance with ethical standards
Conflict of interest The authors declare that they have no conflict of
interest.
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