Table 2.
Primary and secondary outcomes (mITT population)
| Plasma-Lyte A | 0.9 % NaCl | P value | |
|---|---|---|---|
| n = 39 | n = 38 | ||
| Bicarbonate <23 mEq/L | |||
| Baseline (hour 0) | 16.9 ± 3.51 | 17.8 ± 2.82 | .004 |
| Hour 4 | 18.5 ± 3.74 | 18.0 ± 3.67 | |
| Bicarbonate <12 mEq/L | |||
| Baseline (hour 0) (n) | 9.3 ± 0.58 (3) | – (0) | NAb |
| Hour 4 (n) | 14.3 ± 4.16 (3) | – (0) | |
| Bicarbonate ≥12–16 mEq/L | |||
| Baseline (hour 0) (n) | 14.5 ± 1.34 (13) | 14.6 ± 1.29 (13) | .04 |
| Hour 4 (n) | 16.1 ± 2.28 (12) | 14.7 ± 2.90 (11) | |
| Bicarbonate >16–22 mEq/L | |||
| Baseline (hour 0) (n) | 19.23 ± 1.86 (23) | 19.51 ± 1.68 (25) | .11 |
| Hour 4 (n) | 20.35 ± 3.18 (22) | 19.53 ± 2.95 (24) | |
| Chloride, mmol/L | |||
| Baseline | 103.03 ± 4.74 | 103.53 ± 4.19 | <0.001 |
| Hour 4 | 104.49 ± 3.18 | 108.51 ± 4.87 | |
| Gorelick dehydration scale | |||
| Baseline (hour 0) | 5.2 ± 0.93 | 5.3 ± 1.11 | .03 |
| Hour 2 | 2.0 ± 1.45 | 2.8 ± 1.74 | |
| Hour 4 | 0.81 ± 0.84 | 1.41 ± 1.08 | .08 |
| FLACC pain scale | |||
| Baseline (Hour 0) | 2.0 ± 1.91 | 1.7 ± 2.00 | .03 |
| Hour 2 | 0.6 ± 0.98 | 1.7 ± 2.59 | |
| Hour 4 | 1.44 ± 2.18 | 0.68 ± 1.35 | .15 |
| FACES pain scale | |||
| Baseline (Hour 0) | 2.3 ± 1.86 | 3.2 ± 1.90 | .31 |
| Hour 2 | 1.1 ± 1.55 | 1.9 ± 1.60 | |
| Hour 4 | 0.37 ± 0.60 | 1.11 ± 1.54 | NA |
| BARF Scale | |||
| Baseline (Hour 0) | 5.10 ± 4.02 | 4.43 ± 3.86 | .27 |
| Hour 2 | 1.5 ± 3.10 | 2.00 ± 2.58 | .55 |
| Hour 4 | 0.3 ± 0.98 | 1.23 ± 2.24 | .12 |
| Time to Rehydrationa, h | 6.1 ± 1.75 | 7.0 ± 2.7 | .13 |
| Hospitalized, n (%) | 12 (31) | 11 (29) | .86 |
BARF, Baxter animated retching faces; FLACC, face, legs, activity, cry, consolability pain assessment scale for children
All data are presented as mean ± standard deviation unless otherwise indicated
aRehydration was defined as the time the clinician determined no further bolus fluid therapy was indicated
bNot available due to sample size (n <10)