Table II.
AE summary in nontreated vs treated Infants
| Demographics | Nontreated n = 81 | Treated n = 123 | P value |
|---|---|---|---|
| Incidence of any AE – n (%) | 8/81 (10%) | 23/123 (19%) | .09 |
| Number of AEs per infant who had an AE – Mean (SD) | 1.1 (0.4) | 1.3 (0.5) | .63 |
| AE type bradycardia – n (%) | 5/81 (6%) | 16/123 (13%) | .12 |
| Heart rate during bradycardic AEs | |||
| Mean (SD) | 75.3 (3.4) | 73.6 (4.8) | .09 |
| Median (IQR) | 75.0 (4.0) | 75.0 (7.0) | .17 |
| AE type oxygen desaturation – n (%) | 4/81 (5%) | 11/123 (9%) | .28 |
| Oxygen saturation during desaturation AEs | |||
| Mean (SD) | 78.1% (6.4) | 76.6% (9.0) | .63 |
| Median (IQR) | 79.0% (5.5) | 80.0% (11.0) | .95 |
| AE type apnea – n (%) | 0 (0%) | 0 (0%) | N/A |
| Duration of morphine treatment at time of first AE (h) | N/A | N/A | |
| Mean (SD) | 19.2 (8.3) | ||
| Median (IQR) | 20.0 (29.8) | ||
| Amount of morphine at time of the first AE (mg/kg/d) | N/A | N/A | |
| Mean (SD) | 0.5 (0.2) | ||
| Median (IQR) | 0.4 (0.7) | ||
| Duration of methadone treatment at time of first AE (h) | N/A | N/A | |
| Mean (SD) | 155.6 (273.1) | ||
| Median (IQR) | 51.4 (765.5) | ||
| Amount of methadone at time of the first AE (mg/kg/d) | N/A | N/A | |
| Mean (SD) | 0.3 (0.2) | ||
| Median (IQR) | 0.2 (0.6) |
N/A, not applicable; NICU, newborn intensive care unit.