Naloxegol to Prevent Constipation in ICU Adults Receiving Opioids: A Randomized Double-Blind Placebo-Controlled Pilot Trial
Table 3
Clinical outcomesA.
Variable
Naloxegol, n = 6
Placebo, n = 6
value
First SBM after enrolment
Time to event, hours, mean ± SD
41 ± 32
33 ± 25
0.56
Size, N (%)
0.19
Small
1 (17)
4 (67)
Medium
3 (50)
2 (33)
Large
2 (33)
0 (0)
Consistency, N (%)
0.77
Hard and formed
1 (17)
0 (0)
Soft but formed
0 (0)
0 (0)
Loose and unformed
4 (67)
4 (67)
Liquid
1 (17)
2 (33)
Maximum daily abdominal pressure score, mmHg, mean ± SD
10 ± 4
13 ± 5
0.002
Score ≥12 mmHg, N (%)
8 (15)
23 (31)
0.003
Score ≥20 mmHg, N (%)
0 (0)
4 (7)
0.12
Maximum daily SOFA score, median (IQR)
7 (4, 8)
4 (3, 5)
<0.001
Study laxative protocol
>0.99
Any use, N (%)
5 (83)
4 (67)
0.13
Highest level needed, N (%)
Step 1
1 (20)
1 (25)
Step 2
4 (80)
1 (25)
Step 3
0
1 (25)
Step 4
0
1 (25)
0.81
Total proportion of study days used, N/total (%)
11/54 (20)
9/51 (18)
Days of scheduled/continuous IV fentanyl use, median (IQR)
5 (3, 7)
4 (3, 6)
0.77
Average daily IV fentanyl equivalents mcg/kg/hr, median (IQR)
0.44 (0.19, 0.72)
0.51 (0.24, 0.82)
0.84
Continuous propofol use
N (%) ever during study
4 (66)
4 (66)
1.0
Days of propofol use, median (IQR)
5 (3–6)
4 (2–5)
0.73
Average daily infusion rate, mcg/kg/min, median (IQR)
28 (21, 33)
29 (20, 32)
0.81
Enteral nutrition
Daily volume, mL, median (IQR)
103 (0, 240)
200 (0, 344)
0.06
Percent of daily goals met, mean ± SD
54
51
0.52
Daily fluid balance, mL, median (IQR)
−338 (−747, −102)
−210 (−660, −208)
0.22
Daily maximum pain score, median (IQR)
0 (0, 3)
0 (0, 0)
0.26
Days without coma or delirium, median (IQR)
1 (0.3, 2)
3 (2, 5)
0.20
Without coma, median (IQR)
3 (1, 3)
7 (4, 7)
0.17
Without delirium, median (IQR)
5 (4, 6)
6 (4, 7)
0.81
Days without mechanical ventilation, median (IQR)
0.5 (0.2, 5)
1 (0.3, 3)
0.69
Duration of ICU stay (days), median (IQR)
15 (11, 20)
10 (9, 14)
0.47
Reintubation during initial ICU stay, N (%)
1 (17)
2 (33)
>0.99
ADaily variable. Percentages are based on the individual days accrued by patients in each group. ICU: intensive care unit; IQR: interquartile range; mL: milliliters; N: number; SBM: spontaneous bowel movement; SD: standard deviation; SOFA: sequential organ function score.
