NCT02966288

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

November 15, 2016

Last Update Submit

November 17, 2020

Conditions

Arthritic Knee Pain

Outcome Measures

Primary Outcomes (2)

  • Pain Medication Usage for Breakthrough Pain

    72 hours

  • Pain Level as Assessed by a Visual Analogue Scale

    72 hours

Secondary Outcomes (9)

  • Pain Medication Usage for Breakthrough Pain

    1 week post treatment

  • Pain Medication Usage for Breakthrough Pain

    2 weeks post treatment

  • Pain Medication Usage for Breakthrough Pain

    3 weeks post treatment

  • Pain Medication Usage for Breakthrough Pain

    4 weeks post treatment

  • Pain Level as Assessed by a Visual Analogue Scale

    1 week post treatment

  • +4 more secondary outcomes

Study Arms (2)

Toradol injection

EXPERIMENTAL

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

Oral NSAID

ACTIVE COMPARATOR

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

Drug: Oral NSAID

Interventions

ToradolDRUG

3-ml solution that contains 2 ml of normal saline and 1 ml of Toradol, 30 mg, will be infused into the affected joint.

Also known as: ketorolac
Toradol injection
Oral NSAIDDRUG

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

Also known as: ibuprofen
Oral NSAID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ketorolac TromethamineKetorolacAnti-Inflammatory Agents, Non-SteroidalIbuprofen

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Kimberly A Chambers, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 17, 2016

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 19, 2020

Record last verified: 2020-11