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Table 8 Premature discontinuation due to an adverse event, and adverse events recorded during the study

From: Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308]

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
  1. aRemifentanil versus fentanyl. bRemifentanil versus morphine.