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

Postoperative Pain Clinical Trial

Official title:

Local Infiltration Analgesia for Total Knee Arthroplasty: Should Ketorolac be Added

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868348
• Other study ID #: 2008-003180-39
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2009
• Last updated: January 22, 2014
• Start date: May 2009
• Est. completion date: September 2011

Study information

• Verified date: July 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Total knee arthroplasty

• Age > 18

• Tolerance for study drugs

• Written informed consent

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketorolac
30 mg (1 ml) infiltration combined with Intraarticular bolus injection of 120 mg (4 ml) ketorolac
• Saline
1 ml infiltration 4 ml intraarticular bolus injection of placebo

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Consumption	Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery	48 hours after surgery	No
Secondary	Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request		within 48 hours after surgery	No
Secondary	Pain Intensity Scores During Walking	Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)	6-24 hours postoperatively	No
Secondary	Home Readiness	Ability to meet discharge criteria (home readiness)	time to fulfilment of discharge criteria	No
Secondary	Length of Hospital Stay		From the day of surgery until discharge	No
Secondary	Pain Intensity During Daily Activity	Pain intensity Visual Analogue Scale (VAS) (VAS; 0, no pain, and 100 mm, worst pain possible)	16 weeks after surgery	No