Ondansetron in childhood gastroenteritis

Date First Published:
June 24, 2007
Last Updated:
April 29, 2010
Report by:
Dr Helen Rumbold, ST3 Emergency Medicine (Poole General Hospital)
Search checked by:
Dr Jude Reay, Poole General Hospital
Three-Part Question:
In [children with vomiting due to viral gastroenteritis] does [ondansetron] reduce the requirement for [IV rehydration]
Clinical Scenario:
A 3 year old child presents to the emergency department with a twenty four hour history of vomiting, diarrhoea and reduced oral intake. You wonder whether giving oral ondansetron would improve the success of oral rehydration and reduce the requirement for IV rehydration.
Search Strategy:
Medline via Ovid interface 1950 – week 3 November 2009 and the Cochrane library issue 4 2008
Search Details:
[{(ondansetron.mp. or exp Ondansetron or zofran.mp.) AND (exp Gastroenteritis or gastroenteritis.mp. or exp Vomiting or vomiting.mp.)} limit to all child (0–18 years)].
Outcome:
Four-hundred and twenty-six papers were found, of which four were relevant. The same papers have been described in a Cochrane review.

Relevant Paper(s):
Study Title Patient Group Study type (level of evidence) Outcomes Key results Study Weaknesses
The Role of oral ondansetron in Children with vomiting as a result of acute gastritis/gastroenteritis who have failed oral rehydration therapy: a randomised control trial. Roslund, G. Hepps, T. Mcguillen, K. 2008, USA 106 patients, 1-10 years old with a clinical diagnosis of acute gastritis/ gastroenteritis, mild or moderate dehydration who had failed controlled oral challenge in ED RCT Proportion of children who received IV hydration Ondansetron had a significantly lower proportion of patients requiring intravenous hydration (p<0.001) Convenience sample

Recruitment (investigator availability, patient refusal, physician refusal).No assessment of inter-observer variability in dehydration scoring. Inconsistent volume of oral rehydration prior to discharge. Lack of follow up diaries<br><br>Conflict of interests: GSK provided the melts for the trial

Need for a return visit for the same illness The patients in the ondansetron group had more vomiting (mean 0.71 vs 0.5 vomits) and diarrhoea (mean 1.76 vs 0.5 episodes) in the week post discharge<br><br>Higher rate returns to ED in ondansetron group vs placebo group)
A randomised clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis. Ramsook, C. Sahagun-Carreon, I. Kozinetz, C et al. 2002, USA 145 children age 6 months–12 years, with at least five episodes of vomiting in the preceding 24 h and had not received any antiemetics. Randomised to either ondansetron melt or placebo RCT Frequency of emesis during the 48 hour period after enrolment The only significant reduction was seen during the period in the ED Subjective illness severity. No quantification of dehydration. Inadequate sample size,
Excluded missing patients in calculations at 24 and 48 hour of follow up<br><br>Conflict of interest: GSK provided funding but no further input

Rates of IV fluid administration Fewer patients required IV fluids in the ondansetron group (P=0.015)
Admission rates Admission rates; lower in ondansetron group: (P=0.007)
Frequency of diarrhoea The ondansetron group had significantly more diarrhoea than placebo.
Oral Ondansetron for Gastroenteritis in a Paediatric Emergency Department . Freedman, S. Adler, M. Seshadri, R et al. 2006, USA 215 patients, <10 years, at least one reported episode of non-bilious, non-bloody vomiting within the 4 h of ED triage, and at least one episode of diarrhoea during the illness with mild to moderate dehydration.

Randomised to ondansetron melt or placebo
RCT Proportion who vomited while receiving oral rehydration therapy Significantly fewer patients vomited during oral rehydration in the ondansetron group (p<0.001 Follow-up substandard, but >80%

Conflicts of interest: GSK provided funding but no other input
Number of episodes of vomiting during oral rehydration therapy Fewer episodes of vomiting during oral rehydration in ondansetron group. (p=<0.001)
Rate of intravenous rehydration Fewer patients in the ondansetron group received intravenous hydration (p<0.003) and the amount of intravenous fluid received (ml/kg) was also reduced
Rate of hospitalisation Admission rates were similar in the two groups Adverse events: more episodes of diarrhoea in ondansetron group
Antiemetic activity of ondansetron in acute gastroenteritis. Cubeddu L, Trujillo L, Talmaciu I, et al. 1997, Venezuela 36 children < age 8 hospitalised for minimum 24 h. Acute gastroenteritis with vomiting >2 episodes in an hour.

Randomised to receive either intravenous ondansetron, metoclopramide or saline placebo
RCT Vomiting episodes within 24 h Placebo mean vomits=5. Ondansetron=2 p=0.048 Small sample size

No details on randomisation procedure

Study supported by GlaxoWellcome Research and Development, UK
Bottom Line:
There is now evidence to suggest that there may be a place for antiemetics in children with mild/moderate dehydration as a result of viral gastroenteritis, who have failed a trial of oral rehydration therapy or when vomiting is a significant barrier to oral rehydration.
References:
  1. Roslund, G. Hepps, T. Mcguillen, K. . The Role of oral ondansetron in Children with vomiting as a result of acute gastritis/gastroenteritis who have failed oral rehydration therapy: a randomised control trial.
  2. Ramsook, C. Sahagun-Carreon, I. Kozinetz, C et al.. A randomised clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis.
  3. Freedman, S. Adler, M. Seshadri, R et al.. Oral Ondansetron for Gastroenteritis in a Paediatric Emergency Department .
  4. Cubeddu L, Trujillo L, Talmaciu I, et al.. Antiemetic activity of ondansetron in acute gastroenteritis.