NCT00868348

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started May 2009

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 10, 2014

Completed
Last Updated

March 10, 2014

Status Verified

July 1, 2013

Enrollment Period

2.1 years

First QC Date

March 24, 2009

Results QC Date

July 10, 2013

Last Update Submit

January 22, 2014

Conditions

Postoperative Pain

Keywords

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Morphine Consumption

    Consumption of intravenous (i.v.) patient-controlled analgesia (PCA) morphine during the first forty-eight hours after surgery

    48 hours after surgery

Secondary Outcomes (5)

  • Time to First i.v. Patient Controlled Analgesia (PCA) Morphine Request

    within 48 hours after surgery

  • Pain Intensity Scores During Walking

    6-24 hours postoperatively

  • Home Readiness

    time to fulfilment of discharge criteria

  • Length of Hospital Stay

    From the day of surgery until discharge

  • Pain Intensity During Daily Activity

    16 weeks after surgery

Study Arms (2)

Saline

PLACEBO COMPARATOR
Drug: Saline

Ketorolac

ACTIVE COMPARATOR
Drug: Ketorolac

Interventions

KetorolacDRUG

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

Also known as: Toradol
Ketorolac
SalineDRUG

1 ml infiltration 4 ml intraarticular bolus injection of placebo

Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

KetorolacKetorolac TromethamineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Karen V Andersen
Organization
Aarhus University Hospital
karenand@rm.dk
51263173

Study Officials

  • Kjels Søballe, Professor

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

March 10, 2014

Results First Posted

March 10, 2014

Record last verified: 2013-07

Locations

DK(1)