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Table 3 Adverse event profile

From: Decreased duration of mechanical ventilation when comparing analgesia-based sedation using remifentanil with standard hypnotic-based sedation for up to 10 days in intensive care unit patients: a randomised trial [ISRCTN47583497]

Characteristic Number of patients (%)
  Remifentanil (n = 57) Comparator (n = 48)
Any adverse event 19 (33) 16 (33)
Any drug-related adverse event 6 (11) 4 (8)
Any serious adverse event 7 (12) 6 (13)
Any drug-related serious adverse event 0 (0) 1 (2)
Premature discontinuation from the study 12 (21) 10 (21)
Deaths 7 (13) 5 (10)
Re-intubated within 10 daysa 7 (25) 2 (12)
Most commonly occurring adverse events (≥ 5%)   
   Hypotension 3 (5) 4 (8)
   Atrial fibrillation 4 (7) 2 (4)
   Vomiting 3 (5) 0 (0)
   Septic shock 0 (0) 3 (6)
  1. aP value for continuity-corrected χ2. 95% confidence interval -4 to 23. P = 0.193. Time to re-intubation ranged from 2 h to 3 days after stopping remifentanil, and 7 hours to 3 days after stopping comparator agent.
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