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

NCT00508495 | Completed Phase 3

• 2 other identifiers: R-01270-A016EudraCT 2006-004075-36
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 8

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).

Conditions

Pain, Postoperative

Keywords

pain, postoperative; replacement, total hip; total hip replacement; arthroplasty, replacement, hip

Outcome Measures

Primary Outcomes (1)

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

  6 hours from first (of four) study drug doses

Study Arms (3)

Test drug

EXPERIMENTAL

Drug: Paracetamol 1% solution

Reference drug

ACTIVE COMPARATOR

Drug: Paracetamol (acetaminophen)

Placebo

PLACEBO COMPARATOR

Drug: 0.9% sodium chloride solution

Interventions

Paracetamol (acetaminophen) DRUG

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

Also known as: Perfalgan

Reference drug

Paracetamol 1% solution DRUG

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

Test drug

0.9% sodium chloride solution DRUG

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

Also known as: Normal saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• MDS Pharma Services: collaborator

Study Sites (8)

Réthy Pál Kórház-Rendelőintézet

Békéscsaba, Hungary

Location

Semmelweis Egyetem Ortopédiai Klinika

Budapest, Hungary

Location

Esztergom Város Önkormányzat Vaszary Kolos Kórháza

Esztergom, Hungary

Location

Petz Aladár Megyei Oktató Kórház

Győr, Hungary

Location

Bács-Kiskun Megyei Önkormányzat Kórháza

Kecskemét, Hungary

Location

SZTE ÁOK Ortopédiai Klinika

Szeged, Hungary

Location

Tolna Megyei Önkormányzat Balassa János Kórháza

Szekszárd, Hungary

Location

Fejér Megyei Szent György Kórház

Székesfehérvár, Hungary

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Solutions; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions

Study Officials

• Keyvan Tadjalli Mehr, MD, MSc

  Baxter Deutschland GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: August 11, 2011

Record last verified: 2011-08

Locations

HU (8)