A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty

NCT ID: NCT00868348

Last Updated: 2014-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

1 ml infiltration 4 ml intraarticular bolus injection of placebo

Ketorolac

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type DRUG

30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac

Interventions

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Ketorolac

30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac

Intervention Type DRUG

Saline

1 ml infiltration 4 ml intraarticular bolus injection of placebo

Intervention Type DRUG

Other Intervention Names

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Toradol

Eligibility Criteria

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Inclusion Criteria

* Total knee arthroplasty
* Age \> 18
* Tolerance for study drugs
* Written informed consent

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kjels Søballe, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2008-003180-39

Identifier Type: -

Identifier Source: org_study_id

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