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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00508495
Enrollment
148
Registered
2007-07-30
Start date
2007-08-31
Completion date
2008-03-31
Last updated
2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

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

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).

Interventions

DRUGParacetamol (acetaminophen)

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

DRUGParacetamol 1% solution

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

DRUG0.9% sodium chloride solution

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

Sponsors

MDS Pharma Services
CollaboratorINDUSTRY
Baxter Healthcare Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Amount of PCA-administered morphine consumed during first six hours of study drug treatment6 hours from first (of four) study drug doses

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026