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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Arthritic Knee Pain
• Intervention / Treatment: Drug: Toradol; Drug: Oral NSAID

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: ketorolac
Active Comparator: Oral NSAID; 800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID))	Drug: Oral NSAID; 800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID)); Other Names: ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Kimberly A Chambers, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ibuprofen; Ketorolac Tromethamine
• Other Study ID Numbers: HSC-MS-16-0616