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

^aRemifentanil versus fentanyl. ^bRemifentanil versus morphine.

Karabinis et al. Critical Care 2004 8:R268   doi:10.1186/cc2896