A Randomized Controlled Trial to Assess the Pain-control Efficacy of Intra-articular Toradol Compared to Oral NSAIDs: A Pilot Study

The University of Texas Health Science Center, Houston0 sitesJanuary 2017

ConditionsArthritic Knee Pain

InterventionsToradol Oral NSAID

DrugsToradol Oral NSAID

Overview

Phase: Phase 4
Intervention: Toradol
Conditions: Arthritic Knee Pain
Sponsor: The University of Texas Health Science Center, Houston
Primary Endpoint: Pain Medication Usage for Breakthrough Pain
Status: Withdrawn
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The study objective is to determine whether a single intra-articular dose of an anti-inflammatory (Toradol) will reduce the need for other analgesic medications and, if so, how long the benefits will last.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

January 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Kimberly A Chambers

Clinical Assistant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

•Patients with radiographic evidence of osteoarthritis (OA) who present to the ED with a chief complaint of knee pain that the treating provider attributes to their arthritis.

Exclusion Criteria

•Acute knee trauma
•Intra-articular steroid injection within 6 months
•History of gout or rheumatoid arthritis
•X ray evidence of pathologic fracture, malignancy, or other non-OA cause of symptoms
•Signs or symptoms or high risk of acute infection: Recent fevers and chills; Erythema, warmth, or pain out of proportion to exam; History of hemodialysis; History of IV drug use
•Lidocaine allergy
•Any contraindication to NSAID therapy, including: Allergy; Pregnancy; History of renal insufficiency; History of gastritis, GERD or GI bleeding; Primary care physician's restriction of its use
•Contraindication to the procedure, including: Hemophilia; History of total knee replacement of the affected joint
•An inability to give informed consent; Active psychosis; Diminished capacity requiring another person to provide consent for medical treatment
•An inability to be contacted for follow-up

Arms & Interventions

Toradol injection

3-ml solution that contains 2 ml of normal saline and 1 ml of Toradol, 30 mg, will be infused into the affected joint.

Intervention: Toradol

Oral NSAID

800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID))

Intervention: Oral NSAID

Outcomes

Primary Outcomes

Pain Medication Usage for Breakthrough Pain

Time Frame: 72 hours

Pain Level as Assessed by a Visual Analogue Scale

Time Frame: 72 hours

Secondary Outcomes

Pain Medication Usage for Breakthrough Pain(4 weeks post treatment)
Pain Level as Assessed by a Visual Analogue Scale(4 weeks post treatment)
Number of Participants who had a second visit to a Emergency Department or Clinic(4 weeks)