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: January 22, 2014
Last verified: July 2013
  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: Saline
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: Local Infiltration Analgesia for Total Knee Arthroplasty: Should Ketorolac be Added

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Morphine Consumption [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
    Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery


Secondary Outcome Measures:
  • Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request [ Time Frame: within 48 hours after surgery ] [ Designated as safety issue: No ]
  • Pain Intensity Scores During Walking [ Time Frame: 6-24 hours postoperatively ] [ Designated as safety issue: No ]
    Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)

  • Home Readiness [ Time Frame: time to fulfilment of discharge criteria ] [ Designated as safety issue: No ]
    Ability to meet discharge criteria (home readiness)

  • Length of Hospital Stay [ Time Frame: From the day of surgery until discharge ] [ Designated as safety issue: No ]
  • Pain Intensity During Daily Activity [ Time Frame: 16 weeks after surgery ] [ Designated as safety issue: No ]
    Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)


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: Saline Drug: Saline
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
Results First Received: July 10, 2013
Last Updated: January 22, 2014
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 April 23, 2014