Table 3.
Adverse events
| Onset of event post drug (h, min) | Treatment | Grade | Attribution | Allocation | |
|---|---|---|---|---|---|
| Adverse events | |||||
| Nasal congestion | 11 h, 56 min | Saline drops | Mild | Not related | Placebo |
| Rash | 4 h, 4 min | Cream | Mild | Not related | Placebo |
| Profound desaturation episodes | 17 h, 59 min | Facial oxygen | Mild | Not related | Placebo |
| Recurrent desaturation episodes | 8 h, 9 min | Stimulation | Mild | Possibly | Morphine |
| Recurrent desaturation episodes | 1 h, 58 min | Facial oxygen | Mild | Possibly | Morphine |
| Apnoea | 2 h, 13 min | NIPPV; increase high-flow oxygen | Moderate | Possibly | Morphine |
| Recurrent apnoeic episodes | 2 h, 39 min | Stimulation; increase low-flow oxygen | Moderate | Possibly | Morphine |
| Recurrent apnoeic episodes | 1 h, 28 min | Stimulation (× 3); NIPPV (× 3) | Moderate | Possibly | Morphine |
| Recurrent desaturation, bradycardia, and apnoeic episodes | 2 h, 3 min | Commenced high-flow oxygen; feed volume reduction | Moderate | Possibly | Morphine |
| Serious adverse events | |||||
| Persistent hypoventilation and desaturation | 6 h, 0 min | Moved to high-dependency unit; commenced high-flow oxygen | Moderate | Possibly | Morphine |
| Recurrent apnoeic episodes | 6 h, 24 min | Unmasked by clinical team; moved to high-dependency unit; commenced high-flow oxygen; naloxone (× 2) | Moderate | Probably | Morphine |
Adverse events are shown that occurred during the 24 h period post administration of morphine or placebo. NIPPV=non-invasive positive pressure ventilation.