Table 2.

The effect of ondansetron on primary and secondary outcomes of the intention to treat population

Effect of ondansetron on primary and secondary outcomesValid, nAll, participants, n= 175Valid, nCAU, n= 88Valid, nIntervention, n= 87Valid, nImputed cases, OR (95% CI)Non-imputed cases, OR (95% CI)
Continued vomiting, hours 1-4, n (%)15448 (31.2)7733 (42.9)7715 (19.5)1540.37 (0.20 to 0.72)0.32 (0.16 to 0.66)
Vomiting episodes, hours 1–4, median (range)a1370.0 (0.0–6.0)670.0 (0.0–6.0)700.0 (0.0–5.0)137IRR 0.51 (0.29 to 0.88)IRR 0.46 (0.21 to 1.03)
Intake ORT, mL, median (IQR)8810.0 (0.0–100.0)460.0 (0.0–72.0)4235.0 (0.0–180.0)88P = 0.522bP = 0.093b
Referrals, n (%)14428 (19.4)7314 (19.2)7114 (19.7)1441.19 (0.60 to 2.36)1.04 (0.45 to 2.36)
Hospital admissions, n (%)13219 (14.4)7310 (13.7)599 (15.3)1321.80 (0.91 to 3.55)1.13 (0.43 to 3.00)
Adverse events, n (%)c9630 (31.3)4819 (39.6)4811 (22.9)960.63 (0.34 to 1.17)0.45 (0.19 to 1.10)
Serious adverse events, n (%)d916 (6.6)464 (8.7)452 (4.4)910.83 (0.45 to 1.54)0.49 (0.09 to 2.81)
Parental satisfaction, median (IQR)1074.0 (3.0–4.0)534.0 (3.0–4.0)544.0 (4.0–5.0)107P = 0.027bP = 0.013b
  • a Complete range provided instead of IQR because data are heavily skewed (IQR = 0–0).

  • b Mann–Whitney U test.

  • c Adverse events: erythema, hiccups, and headache.

  • d Serious adverse events: spasms/convulsions and breathing problems. Bold = statistically significant difference. CAU = care as usual. IQR = interquartile range. IRR = incidence rate ratio. OR = odds ratio. ORT = oral rehydration therapy.