Skip to content

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02966288
Enrollment
0
Registered
2016-11-17
Start date
2017-01-31
Completion date
2019-01-31
Last updated
2020-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritic Knee Pain

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.

Interventions

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

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

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain Medication Usage for Breakthrough Pain72 hours
Pain Level as Assessed by a Visual Analogue Scale72 hours

Secondary

MeasureTime frameDescription
Number of Participants who had a second visit to a Emergency Department or Clinic4 weeks
Pain Medication Usage for Breakthrough Pain1 week post treatmentThe number of pills will be reported
Pain Level as Assessed by a Visual Analogue Scale1 week post treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026