Naloxegol to Prevent Constipation in ICU Adults Receiving Opioids: A Randomized Double-Blind Placebo-Controlled Pilot Trial

Table 2

Patient characteristics at baseline.

Variable	Naloxegol, n = 6	Placebo, n = 6
Age, years, mean ± SD	51 ± 23	64 ± 11
Male, N (%)	3 (50)	2 (33)
BMI, mean ± SD	40 ± 13	35 ± 16
Apache-II score, mean ± SD	20 ± 6	19 ± 7
SOFA score, mean ± SD	8 ± 4	6 ± 2
Medical (vs. surgical), N (%)	6 (100)	6 (100)
Mechanically ventilated, N (%)	6 (100)	6 (100)
Hours in the ICU before enrolment, mean ± SD	50 ± 21	44 ± 21
Admission diagnosis, N (%)
Pneumonia	2 (33)	2 (33)
Cardiac	2 (33)	2 (33)
Respiratory failure	1 (17)	1 (17)
ARDS	1 (17)	1 (17)
Last SBM prior to enrolment, days, mean ± SD	3 ± 2	3 ± 2
Scheduled/continuous IV opioid medication, n (%)
Fentanyl	5 (83)	6 (100)
Hydromorphone	1 (17)	0 (0)
Opioid exposure in the prior 24 hours
Total IV fentanyl equivalents (mcg), median (IQR)	1420 (650, 3548)	1600 (1104, 2381)
IV fentanyl equivalents mcg/kg/hr, median (IQR)	0.54 (0.25, 0.98)	0.61 (0.29, 0.94)
Continuous propofol use in the prior 24 hours
N (%)	4 (66)	4 (66)
Infusion rate, mcg/kg/min, median (IQR)	32 (25, 37)	35 (27, 43)
Location prior to ICU admission, n (%)
Emergency department	1 (17)	1 (17)
Hospital ward	1 (17)	2 (33)
ICU at outside hospital	3 (50)	2 (33)
Ward at outside hospital	1 (17)	1 (17)
Past medical history, n (%)
Asthma/COPD	1 (17)	0 (0)
Diabetes	2 (33)	1 (17)
GERD	2 (33)	1 (17)
Heart failure	0 (0)	0 (0)
Hypertension	2 (33)	3 (50)
Past surgical history, n (%)
Abdominal	0 (0)	0 (0)
Cardiovascular	0 (0)	1 (17)
Orthopedic	1 (17)	2 (33)
Thoracic	0 (0)	0 (0)

ARDS: acute respiratory distress syndrome; APACHE: acute physiologic and chronic health evaluation; BMI: body mass index; COPD: chronic obstructive pulmonary disease; GERD: gastroesophageal reflux disease; ICU: intensive care unit; IQR: interquartile range; IV: intravenous; SBM: spontaneous bowel movement; SD: standard deviation; SOFA: sequential organ failure assessment.