Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain

Last updated: August 10, 2011
Sponsor: Baxter Healthcare Corporation
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00508495
R-01270-A016
EudraCT 2006-004075-36
  • Ages 18-75
  • All Genders

Study Summary

The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ASA I, II or III and scheduled for elective total hip replacement, using a standardapproach and a cemented implant.

  • Moderate or severe pain within 4 hours after stopping the PCA in the morning of thefirst post-operative day.

Exclusion

Exclusion Criteria:

  • Another acute or chronic painful physical condition

  • Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well asmicrosomal enzyme inducers

  • Inability to use and understand Visual Analog Scale and Verbal Rating Score

Study Design

Total Participants: 148
Study Start date:
August 01, 2007
Estimated Completion Date:
March 31, 2008

Connect with a study center

  • Semmelweis Egyetem Ortopédiai Klinika

    Budapest,
    Hungary

    Site Not Available

  • Réthy Pál Kórház-RendelÅ‘intézet

    Békéscsaba,
    Hungary

    Site Not Available

  • Réthy Pál Kórház-Rendelőintézet

    Békéscsaba,
    Hungary

    Site Not Available

  • Esztergom Város Önkormányzat Vaszary Kolos Kórháza

    Esztergom,
    Hungary

    Site Not Available

  • Petz Aladár Megyei Oktató Kórház

    Győr,
    Hungary

    Site Not Available

  • Petz Aladár Megyei Oktató Kórház

    Győr,
    Hungary

    Site Not Available

  • Bács-Kiskun Megyei Önkormányzat Kórháza

    Kecskemet,
    Hungary

    Site Not Available

  • SZTE ÁOK Ortopédiai Klinika

    Szeged,
    Hungary

    Site Not Available

  • Fejér Megyei Szent György Kórház

    Szekesfehervar,
    Hungary

    Site Not Available

  • Tolna Megyei Önkormányzat Balassa János Kórháza

    Szekszárd,
    Hungary

    Site Not Available

  • Tolna Megyei Önkormányzat Balassa János Kórháza

    Szekszárd,
    Hungary

    Site Not Available

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