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Ondansetron Oral Dissolve Tab vs. Oral Solution in Children Presenting to the Emergency Department with Gastroenteritis.
J Emerg Med. 2016 Nov; 51(5):491-497.JE

Abstract

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.

OBJECTIVES

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.

Authors+Show Affiliations

Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.Department of Pediatrics, Primary Children's Hospital, University of Utah, Salt Lake City, Utah.Faculty of Medicine, Columbia University, New York, New York.Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27624509

Citation

Thompson, Graham C., et al. "Ondansetron Oral Dissolve Tab Vs. Oral Solution in Children Presenting to the Emergency Department With Gastroenteritis." The Journal of Emergency Medicine, vol. 51, no. 5, 2016, pp. 491-497.
Thompson GC, Morrison EL, Chaulk D, et al. Ondansetron Oral Dissolve Tab vs. Oral Solution in Children Presenting to the Emergency Department with Gastroenteritis. J Emerg Med. 2016;51(5):491-497.
Thompson, G. C., Morrison, E. L., Chaulk, D., Wobma, H., Kwong, S., & Johnson, D. W. (2016). Ondansetron Oral Dissolve Tab vs. Oral Solution in Children Presenting to the Emergency Department with Gastroenteritis. The Journal of Emergency Medicine, 51(5), 491-497. https://doi.org/10.1016/j.jemermed.2016.06.051
Thompson GC, et al. Ondansetron Oral Dissolve Tab Vs. Oral Solution in Children Presenting to the Emergency Department With Gastroenteritis. J Emerg Med. 2016;51(5):491-497. PubMed PMID: 27624509.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ondansetron Oral Dissolve Tab vs. Oral Solution in Children Presenting to the Emergency Department with Gastroenteritis. AU - Thompson,Graham C, AU - Morrison,Ellen L, AU - Chaulk,David, AU - Wobma,Holly, AU - Kwong,Simon, AU - Johnson,David W, Y1 - 2016/09/10/ PY - 2016/02/18/received PY - 2016/06/07/revised PY - 2016/06/29/accepted PY - 2016/10/30/pubmed PY - 2017/10/17/medline PY - 2016/9/15/entrez KW - child KW - emergency department KW - gastroenteritis KW - ondansetron SP - 491 EP - 497 JF - The Journal of emergency medicine JO - J Emerg Med VL - 51 IS - 5 N2 - 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. OBJECTIVES: 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. SN - 0736-4679 UR - https://www.unboundmedicine.com/medline/citation/27624509/Ondansetron_Oral_Dissolve_Tab_vs__Oral_Solution_in_Children_Presenting_to_the_Emergency_Department_with_Gastroenteritis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0736-4679(16)30379-1 DB - PRIME DP - Unbound Medicine ER -