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

• Status: Withdrawn
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Ibuprofen; Ketorolac; Ketorolac Tromethamine

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