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Table 2 Incidence of relevant side effect events

From: Combatting pain after orthopedic/trauma surgery- perioperative oral extended-release tapentadol vs. extended-release oxycodone/naloxone

 

Tapentadol

Oxycodone/naloxone

 

Frequency (Percent)

Frequency (Percent)

p-value (CHI2)

Nausea (≥3)

17 (13%)

23 (18%)

0.23

Vomiting (≥3)

4 (3%)

10 (8%)

0.09

Constipation (≥1)

47 (35%)

39 (30%)

0.33

Sedation (≥3)

8 (6%)

12 (9%)

0.33

Vertigo (≥3)

7 (5%)

5 (4%)

0.57

Somnolence (≥1)

3 (2%)

1 (0.8%)

0.32

Overall AE score (≥5)

40 (30%)

43 (33%)

0.63

Relevant adverse event

68 (51%)

63 (48%)

0.62

  1. The severity of the respective side effect was rated with a daily score of 0–2, where 0 is absence of the respective side effect, 1 is side effect observed but no requirement for intervention, 2 is side effect requiring intervention. We defined, that a patient had a relevant side effect event at a sum score over the 5-days observation period of constipation and/or somnolence ≥1 and/or nausea, vomiting, sedation and/or vertigo ≥3, and/or an overall sum score ≥ 5
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BMC Anesthesiology

ISSN: 1471-2253

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