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An exploratory, randomised, parallel-group, open-label, multicentre study to assess the post-operative management of moderate to severe pain in patients who underwent laparoscopic cholecystectomy, rec...

Update Il y a 4 ans
Reference: EUCTR2008-003566-26

An exploratory, randomised, parallel-group, open-label, multicentre study to assess the post-operative management of moderate to severe pain in patients who underwent laparoscopic cholecystectomy, receiving oxycodone hydrochloride i.v. within 12 - 24 hours after surgery at first and then oxycodone / naloxone prolonged release tablets compared to patients receiving piritramide infusions

Woman and Man

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Extract

The primary objectives of this trial is to demonstrate non-inferiority of oxycodone/naloxone prolonged release tablets (OXN) compared to piritramide infusions with respect to post operative pain intensity 3 hours after administering first oral or intravenous medication on day 1 post surgery (V2).

Inclusion criteria

  • post-operative management of moderate to severe pain in patients who underwent laparoscopic cholecystectomy

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