Characteristic | Study Groups | All patients | P value | |
---|---|---|---|---|
Placebo n = 30 (%) | Melatonin n = 30 (%) | Total n = 60 (%) | ||
Incident Delirium Diagnosis (IDD) | ||||
 Cumulative 28-day incidence | 10 (33.3) | 11 (36.7) | 21 (35.0) | 0.787 |
 Total person-days at risk | 521 | 411 | 932 |  |
 Incidence rate per person-day [95% Confidence interval] | 0.019 [0.010–0.036] | 0.027 [0.015–0.048] | 0.023[0.015–0.036] | 0.227 |
 First quartile delirium-free survival time (days) | 18 | 9 | 10 | 0.433 |
Severity measures at IDD | ||||
 MDASa completed < 24 h of IDD | 6 (60.0) | 6 (54.5) | 12 (57.1) | 0.331 |
 MDAS scoreb | 13.5 (11–17) | 18 (16–20) | 16.5 (12–18) | 0.090 |
 Clinician Global Rating (CGR) | ||||
  Mild | 2/10 [20.0] | 3/11 [27.3] | 5/21 [23.8] | 0.632 |
  Moderate | 6/10 [60.0] | 8/11 [72.7] | 14/21 [66.7] | |
  Severe | 2/10 [20.0] | 0/11 [0] | 2/21 [9.5] | |
 Nu-DESC ratingsc | ||||
  Total number of ratings available over 72 hd at IDDb | 7 (6–9) | 8 (6–9) | 8 (6–9) | 0.462 |
  Maximum total Nu-DESC score over 72 hd at IDDb | 4 (3–6) | 3 (1–5) | 3 (2–5) | 0.191 |
  Maximum total Nu-DESC score during day of IDDb | 6 (4–7) | 3 (3–5) | 4 (3–6) | 0.144 |