Table 3 Incidence of adverse events (intention-to-treat population)
Event, n (%) | Nitrous oxide/oxygen plus acetaminophen (n = 340) | Morphine (n = 344) |
|---|---|---|
Adverse events in the 30 min after starting treatment | ||
≥1 expected adverse event | 45 (13.2) | 35 (10.2) |
Respiratory depression (< 10 cycles/min or score ≥ R1) | 4 (1.2) | 5 (1.5) |
Nausea (without vomiting) | 11 (3.2) | 8 (2.3) |
Vomiting | 17 (5.0) | 16 (4.7) |
Sedation (score of ≥2) | 15 (4.4) | 7 (2.0) |
Dizziness | 3 (0.9) | 3 (0.9) |
Pruritus | 0 | 3 (0.9) |
≥1 unexpected serious adverse event | 21 (6.2) | 12 (3.5) |
Adverse event that led to treatment interruption | 24 (7.1) | 4 (1.2) |
Serious adverse event in the 30 days after enrolment | 64 (18.8) | 55 (16.0) |
Adverse event occurring in ≥1% of patients | ||
Ventricular tachycardia | 21 (6.2) | 5 (1.5) |
Ventricular fibrillation | 8 (2.4) | 5 (1.5) |
Cardiogenic shock | 5 (1.5) | 7 (2.0) |
Heart failure | 3 (0.9) | 5 (1.5) |
Death in the 30 days after enrolment | 6 (1.8) | 13 (3.8) |