A Trial to Assess the Pain-control Efficacy of Intra-articular Toradol Compared to Oral NSAIDs

Study Overview
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Brief Summary
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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.

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

Conditions
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Arthritic Knee Pain

Intervention / Treatment
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* Drug: Toradol
* Drug: Oral NSAID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toradol injection<br>3-ml solution that contains 2 ml of normal saline and 1 ml of Toradol, 30 mg, will be infused into the affected joint. | Drug: Toradol<br>* 3-ml solution that contains 2 ml of normal saline and 1 ml of Toradol, 30 mg, will be infused into the affected joint.<br>* Other names: ketorolac;|
| Active Comparator: Oral NSAID<br>800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID)) | Drug: Oral NSAID<br>* 800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID))<br>* Other names: ibuprofen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Medication Usage for Breakthrough Pain |  | 72 hours | 
| Pain Level as Assessed by a Visual Analogue Scale |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Medication Usage for Breakthrough Pain | The number of pills will be reported | 1 week post treatment | 
| Pain Medication Usage for Breakthrough Pain | The number of pills will be reported | 2 weeks post treatment | 
| Pain Medication Usage for Breakthrough Pain | The number of pills will be reported | 3 weeks post treatment | 
| Pain Medication Usage for Breakthrough Pain | The number of pills will be reported | 4 weeks post treatment | 
| Pain Level as Assessed by a Visual Analogue Scale |  | 1 week post treatment | 
| Pain Level as Assessed by a Visual Analogue Scale |  | 2 weeks post treatment | 
| Pain Level as Assessed by a Visual Analogue Scale |  | 3 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 |