Ondansetron Oral Dissolve Tab vs. Oral Solution in Children Presenting to the Emergency Department with Gastroenteritis.
BACKGROUND
Ondansetron is often used in the emergency department (ED) to promote oral rehydration in children with acute gastroenteritis (AGE), yet medication solutions administered orally may be poorly tolerated in this population.


OBJECTIVE
We compared the tolerability of ondansetron oral dissolve tab (ODT) to oral solution (OS) in children presenting to the ED with AGE.


METHODS
Using alternate-day controlled clinical trial design, children aged 3 months to 10 years received either ondansetron ODT or OS. Our primary outcome was early vomiting (within 15 min of drug administration). The secondary outcome was intravenous (i.v.) fluid administration.


RESULTS
There were 462/534 eligible children who met study criteria. Demographics, severity, and duration of illness were similar between groups. Using intention-to-treat analysis, early vomiting occurred in 8/209 ODT vs. 19/253 OS children (3.8% vs. 7.5%; odds ratio [OR] 0.49; 95% confidence interval [CI] 0.18-1.21). Using as-treated analysis, 6/222 (2.7%) children receiving ODT experienced early vomiting, compared with 21/221 (9.5%) of the OS group (OR 0.26; 95% CI 0.09-0.70). The proportion of children discharged without i.v. fluids was not different (intention-to-treat: ODT = 91.4% (191/209), OS = 94.1% (238/253), OR 1.49, 95% CI 0.69-3.28; as-treated: ODT = 92.3% (205/222), OS = 93.2% (206/221), OR 0.88, 95% CI 0.40-1.93).


CONCLUSIONS
Using a conservative intention-to-treat analysis, we found that children presenting to an ED with AGE did not have statistically less early vomiting with ondansetron ODT as compared with OS. However, our as-treated analysis demonstrates that children receiving ondansetron ODT experienced early vomiting approximately one-third as often as those receiving OS. The rate of i.v. fluid administration was no different between groups regardless of the type of analysis used.
Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.
Graham C
GC
Thompson
Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.
Ellen L
EL
Morrison
Department of Pediatrics, Primary Children's Hospital, University of Utah, Salt Lake City, Utah.
David
D
Chaulk
Faculty of Medicine, Columbia University, New York, New York.
Holly
H
Wobma
Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Simon
S
Kwong
Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.
David W
DW
Johnson
D000284:Administration, Oral; D000932:Antiemetics / Q000494:pharmacology / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004636:Emergency Service, Hospital / Q000458:organization & administration / Q000706:statistics & numerical data; D005260:Female; D005440:Fluid Therapy / Q000379:methods / Q000706:statistics & numerical data; D005759:Gastroenteritis / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D008297:Male; D017294:Ondansetron / Q000494:pharmacology* / Q000627:therapeutic use; D014839:Vomiting / Q000150:complications / Q000188:drug therapy* / Q000209:etiology
D000932:Antiemetics; D017294:Ondansetron
child; emergency department; gastroenteritis; ondansetron