Table 8 Premature discontinuation due to an adverse event, and adverse events recorded during the study
Parameter | Remifentanil (n = 84) | Fentanyl (n = 37) | Morphine (n = 40) | ||
|---|---|---|---|---|---|
Premature discontinuation from the study due to an adverse event | 6 (7%) | 1 (3%) | 2 (5%) | ||
Patients with any adverse event | 32 (38%) | 9 (24%) | 12 (30%) | ||
Patients with a drug-related adverse event | 21 (25%) | 3 (8%) | 4 (10%) | ||
Number (%) of patients with any adverse event | |||||
Treatment period | |||||
Maintenance phase | 29 (35%) | 8 (22%) | 10 (25%) | ||
Extubation phase | 2 (2%) | 0 | 0 | ||
Post-extubation phase | 2 (2%) | 0 | 0 | ||
Post-treatment period | 5 (6%) | 4 (11%) | 2 (5%) | ||
Number (%) of patients with a serious adverse event | 4 (5%) | 2 (5%) | 2 (5%) | ||
Number (%) of patients with a drug-related serious adverse event | 1 (1%) | 0 | 0 | ||
Summary of adverse events occurring in 5% or more of patients | |||||
Event | Remifentanil | Fentanyl | Morphine | P a | P b |
Hypotension | 12 (14%) | 4 (11%) | 2 (5%) | 0.774 | 0.223 |
Bradycardia | 5 (6%) | 2 (5%) | 2 (5%) | 1.000 | 1.000 |
Polyuria | 3 (4%) | 2 (5%) | 0 | 0.641 | 0.550 |