Effect of ondansetron on primary and secondary outcomes | Valid, n | All, participants, n= 175 | Valid, n | CAU, n= 88 | Valid, n | Intervention, n= 87 | Valid, n | Imputed cases, OR (95% CI) | Non-imputed cases, OR (95% CI) |
---|---|---|---|---|---|---|---|---|---|
Continued vomiting, hours 1-4, n (%) | 154 | 48 (31.2) | 77 | 33 (42.9) | 77 | 15 (19.5) | 154 | 0.37 (0.20 to 0.72) | 0.32 (0.16 to 0.66) |
Vomiting episodes, hours 1–4, median (range)a | 137 | 0.0 (0.0–6.0) | 67 | 0.0 (0.0–6.0) | 70 | 0.0 (0.0–5.0) | 137 | IRR 0.51 (0.29 to 0.88) | IRR 0.46 (0.21 to 1.03) |
Intake ORT, mL, median (IQR) | 88 | 10.0 (0.0–100.0) | 46 | 0.0 (0.0–72.0) | 42 | 35.0 (0.0–180.0) | 88 | P = 0.522b | P = 0.093b |
Referrals, n (%) | 144 | 28 (19.4) | 73 | 14 (19.2) | 71 | 14 (19.7) | 144 | 1.19 (0.60 to 2.36) | 1.04 (0.45 to 2.36) |
Hospital admissions, n (%) | 132 | 19 (14.4) | 73 | 10 (13.7) | 59 | 9 (15.3) | 132 | 1.80 (0.91 to 3.55) | 1.13 (0.43 to 3.00) |
Adverse events, n (%)c | 96 | 30 (31.3) | 48 | 19 (39.6) | 48 | 11 (22.9) | 96 | 0.63 (0.34 to 1.17) | 0.45 (0.19 to 1.10) |
Serious adverse events, n (%)d | 91 | 6 (6.6) | 46 | 4 (8.7) | 45 | 2 (4.4) | 91 | 0.83 (0.45 to 1.54) | 0.49 (0.09 to 2.81) |
Parental satisfaction, median (IQR) | 107 | 4.0 (3.0–4.0) | 53 | 4.0 (3.0–4.0) | 54 | 4.0 (4.0–5.0) | 107 | P = 0.027b | P = 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.