Table 2 Outcomes in cases and controls
From: Chloral hydrate enteral infusion for sedation in ventilated children: the CHOSEN pilot study
Outcome | CHOSEN (n = 21) | Controls (n = 21) | p value |
|---|---|---|---|
Days on study | |||
4.5 (2.2) | - | - | |
4.4 (IQR 2.3, 6.7) | |||
Primary outcomes | |||
Pre-defined feasibility | 21/21 (100%) | - | - |
Any pre-specified adverse effecta | 0 | 0 | - |
SAEb | 1 (5%) | 0 | 0.99 |
Mortality in PICU | 0 | 1 (5%) | 0.99 |
Post-hoc feasiblity | 20/21 (95%) | 20/21 (95%) | 0.99 |
Main secondary outcomes | |||
Days to titration of adequate sedation | 1.4 (1.3) | 0.9 (1.3) | 0.22 |
1 (IQR 0.5, 2.5) | 0.5 (IQR 0, 1.3) | ||
Hours to awakening | N = 19 | N = 18 | 0.80 |
8.1 (8.4) | 8.8 (8.5) | ||
5 (IQR 2, 9) | 8 (IQR 1, 13) | ||
Fluid balance, 48 h (ml/kg) | −2 (45) | 26 (46) | 0.051 |
−7 (IQR −30, 25) | 19 (IQR −4, 59) | ||
Number of prn sedation doses from 12 h pre to 12 h post baseline | 4.7 (3.3) to 2.6 (2.8) | 2.9 (3.9) to 3.4 (5.0) | 0.009/0.74 |
Other secondary outcomes | |||
Ventilator hours | 125 (84) | 258 (363) | 0.12 |
106 (IQR 54, 162) | 129 (IQR 63, 191) | ||
PICU days | 9.8 (7.6) | 16.8 (21.7) | 0.17 |
8.5 (IQR 5, 13) | 8 (IQR 5.5, 12) | ||
Extubation information | |||
Propofol used as bridge to extubation | 13 (62%) | 6 (29%) | 0.06 |
Failed extubation due to sedation | 0/21 | 0/19 | - |
Post-extubation withdrawal syndrome | |||
Signs of withdrawal | 9/20 (45%) | 8/19 (42%) | 0.99 |
Enteral narcotic started within 48 h | 3 (15%) | 4 (22%) | 0.99 |
Enteral BDZ started within 48 h | 4 (19%) | 2 (11%) | 0.66 |
Enteral clonidine started within 48 h | 3 (15%) | 2 (11%) | 0.99 |
Withdrawal score 48 h after extubation | N = 12/21 (57%) | N = 14/21 (67%) | 0.53 |
4.3 (3.3) | 2.3 (2.5) | 0.10 | |
Fluid balance, 24 h (ml/kg) | 5 (32) | 24 (31) | 0.06 |
3 (IQR −17, 32) | 21 (IQR −3, 49) | ||