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

Pain, Postoperative Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00508495
• Other study ID #: R-01270-A016
• Secondary ID: EudraCT 2006-004
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2007
• Last updated: August 10, 2011
• Start date: August 2007
• Est. completion date: March 2008

Study information

• Verified date: August 2011
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Paracetamol (acetaminophen)
Four 100 mL, 15 min IV infusions at six hour intervals
• Paracetamol 1% solution
Four 100 mL, 15 min IV infusions at six hour intervals
• 0.9% sodium chloride solution
Four 100 mL, 15 min IV infusions at six hour intervals

Locations

Country	Name	City	State
Hungary	Réthy Pál Kórház-Rendelointézet	Békéscsaba
Hungary	Semmelweis Egyetem Ortopédiai Klinika	Budapest
Hungary	Esztergom Város Önkormányzat Vaszary Kolos Kórháza	Esztergom
Hungary	Petz Aladár Megyei Oktató Kórház	Gyor
Hungary	Bács-Kiskun Megyei Önkormányzat Kórháza	Kecskemet
Hungary	SZTE ÁOK Ortopédiai Klinika	Szeged
Hungary	Fejér Megyei Szent György Kórház	Szekesfehervar
Hungary	Tolna Megyei Önkormányzat Balassa János Kórháza	Szekszárd

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	MDS Pharma Services

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of PCA-administered morphine consumed during first six hours of study drug treatment		6 hours from first (of four) study drug doses	No