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

This study has been completed.
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
First received: March 24, 2009
Last updated: January 22, 2014
Last verified: July 2013

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


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

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

Aarhus University
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
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
Signs and Symptoms
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 17, 2014