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Completed

NCT Number: NCT00508495

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

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).

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Semmelweis Egyetem Ortopédiai Klinika, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.
  • Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.

Exclusion criteria

  • Another acute or chronic painful physical condition
  • Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
  • Inability to use and understand Visual Analog Scale and Verbal Rating Score

Treatment and study plan

Paracetamol (acetaminophen)

Drug

Four 100 mL, 15 min IV infusions at six hour intervals

Other names: Perfalgan

Paracetamol 1% solution

Drug

Four 100 mL, 15 min IV infusions at six hour intervals

0.9% sodium chloride solution

Drug

Four 100 mL, 15 min IV infusions at six hour intervals

Other names: Normal saline solution

Primary outcomes

  1. Amount of PCA-administered morphine consumed during first six hours of study drug treatment

    Time frame: 6 hours from first (of four) study drug doses

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Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Collaborators

  • MDS Pharma Services

Registry information

Official study title

Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 30, 2007
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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