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

Phase 4

Withdrawn

• Conditions: Arthritic Knee Pain
• Interventions: Drug: Toradol; Drug: Oral NSAID

• Registration Number: NCT02966288
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-17
• Study Start: 2017-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toradol injection	Toradol	3-ml solution that contains 2 ml of normal saline and 1 ml of Toradol, 30 mg, will be infused into the affected joint.
Oral NSAID	Oral NSAID	800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID))

Primary Outcome Measures

Name	Time	Method
Pain Medication Usage for Breakthrough Pain	72 hours
Pain Level as Assessed by a Visual Analogue Scale	72 hours

Secondary Outcome Measures

Name	Time	Method
Pain Medication Usage for Breakthrough Pain	4 weeks post treatment	The number of pills will be reported
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