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Table 2 Primary and secondary outcomes (mITT population)

From: A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis

 

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

  1. BARF, Baxter animated retching faces; FLACC, face, legs, activity, cry, consolability pain assessment scale for children
  2. All data are presented as mean ± standard deviation unless otherwise indicated
  3. aRehydration was defined as the time the clinician determined no further bolus fluid therapy was indicated
  4. bNot available due to sample size (n <10)
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BMC Pediatrics

ISSN: 1471-2431

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