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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00868348
First received: March 24, 2009
Last updated: November 11, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Postoperative Pain
 Drug: Ketorolac
Drug: NaCL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Naropin and Ketorolac for Postoperativ Analgesia After Total Knee Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Analgesic consumption [ Time Frame: 6, 24 and 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Scores (VAS) [ Time Frame: 6,24, 48, 72 and 96 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: NaCL Drug: NaCL
1 ml infiltration 4 ml intraarticular bolus injection of placebo
Active Comparator: Ketorolac Drug: Ketorolac
30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
Other Name: Toradol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868348

Locations
Denmark
Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Kjels Søballe, Professor Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00868348     History of Changes
Other Study ID Numbers: 2008-003180-39
Study First Received: March 24, 2009
Last Updated: November 11, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Total Knee Arthroplasty

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013