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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.