Table 4.
Primary and secondary study outcomes
| Outcome | Paracetamol (n = 94) | Morphine (n = 100) | P-value |
|---|---|---|---|
| Cumulative morphine consumption, (Median (IQR)), mcg/kg* | 145.0 (115.0–432.5) | 692.6 (532.7- 856.1) | < 0.001 |
| Rescue morphine dose total, median (IQR), mcg/kg* | 29.4 (0–45.7) | 30.0 (0–70.9) | 0.38 |
| Patients with rescue morphine bolus, (n) (%)* | 62 (66.0%) | 69 (69.0%) | 0.76 |
| Patients with rescue morphine infusions (n)* | 40(42.3%) | 42 (42.0%) | 1.00 |
| Co-medication (n)* | |||
|
Midazolam Lorazepam Propofol Fentanyl Clonidine Ketamine Dexmedetomidine |
76 (80.9%) 5 (5.3%) 26 (27.7%) 8 (8.5%) 6 (6.4%) 23 (24.5%) 6 (6.4%) |
77 (77%) 10 (10%) 19 (19%) 10 (10%) 5 (5%) 21 (21.0%) 8 (8%) |
0.59 0.29 0.18 0.81 0.67 0.54 0.68 |
| PICU stay in days ( median(IQR)) | 3 (2–6) | 2 (1–5) | 0.10 |
| Duration postoperative mechanical ventilation (median, IQR, hours) | 11.8 (4.5–45.6) | 15.4 (5.7–28.8) | 0.39 |
| Reintubation (n, %)* | 3 (3.2) | 2 (2) | 0.68 |
| Adverse events** | |||
|
Hemodynamic instability (bradycardia or hypotension) Gastrointestinal (obstruction, obstipation, vomiting) Delirium Apnea |
22 (23.4%) 3 (3.2%) 3 (3.2%) 3 (3.2%) |
28 (28%) 1 (1%) 5 (5%) 2 (5%) |
0.46 0.28 0.53 0.60 |
| VIS | 5 (0–9.6) | 5 (3.0–10) | 0.21 |
| NRS ≥ 4 at least once (n,%)* | 55 (59%) | 62 (62%) | 0.62 |
| Comfort-B scale scores (median, range)* | 12 (8–22) | 12 (7–20) | 0.05 |
*48 h postoperative
** 96 h postoperative
PICU = Pediatric Intensive Care Unit, NRS = Numeric Rating Scale, VIS = Vasoactive Inotropic Score