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

NCT ID: NCT02966288

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-01-31

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.

Detailed Description

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Conditions

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Arthritic Knee Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Toradol

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Oral NSAID

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Oral NSAID

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

Intervention Type DRUG

Other Intervention Names

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ketorolac ibuprofen

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Kimberly A Chambers

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kimberly A Chambers, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Countries

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United States

Other Identifiers

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HSC-MS-16-0616

Identifier Type: -

Identifier Source: org_study_id