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

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Paracetamol 1% solution; Drug: 0.9% sodium chloride solution; Drug: Paracetamol (acetaminophen)

• Registration Number: NCT00508495
• Lead Sponsor: Baxter Healthcare Corporation

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-26
• Study First Submitted QC: 2007-07-26
• Study First Posted: 2007-07-30
• Study Start: 2007-08
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-10
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test drug	Paracetamol 1% solution	-
Placebo	0.9% sodium chloride solution	-
Reference drug	Paracetamol (acetaminophen)	-

Primary Outcome Measures

Name	Time	Method
Amount of PCA-administered morphine consumed during first six hours of study drug treatment	6 hours from first (of four) study drug doses

Trial Locations

Locations (8)

Semmelweis Egyetem Ortopédiai Klinika; 🇭🇺 Budapest, Hungary

Réthy Pál Kórház-Rendelőintézet; 🇭🇺 Békéscsaba, Hungary

Esztergom Város Önkormányzat Vaszary Kolos Kórháza; 🇭🇺 Esztergom, Hungary

Fejér Megyei Szent György Kórház; 🇭🇺 Szekesfehervar, Hungary

Tolna Megyei Önkormányzat Balassa János Kórháza; 🇭🇺 Szekszárd, Hungary

Petz Aladár Megyei Oktató Kórház; 🇭🇺 Győr, Hungary

Bács-Kiskun Megyei Önkormányzat Kórháza; 🇭🇺 Kecskemet, Hungary

SZTE ÁOK Ortopédiai Klinika; 🇭🇺 Szeged, Hungary