Clinical trial NCT02966288: A Trial to Assess the Pain-control Efficacy of Intra-articular Toradol Compared to Oral NSAIDs
Official title: A Randomized Controlled Trial to Assess the Pain-control Efficacy of Intra-articular Toradol Compared to Oral NSAIDs: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Arthritic Knee Pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain Medication Usage for Breakthrough Pain
timeFrame: 72 hours
measure: Pain Level as Assessed by a Visual Analogue Scale
timeFrame: 72 hours
Secondary outcomes:
measure: Pain Medication Usage for Breakthrough Pain
timeFrame: 1 week post treatment
measure: Pain Medication Usage for Breakthrough Pain
timeFrame: 2 weeks post treatment
measure: Pain Medication Usage for Breakthrough Pain
timeFrame: 3 weeks post treatment
measure: Pain Medication Usage for Breakthrough Pain
timeFrame: 4 weeks post treatment
measure: Pain Level as Assessed by a Visual Analogue Scale
timeFrame: 1 week post treatment
measure: Pain Level as Assessed by a Visual Analogue Scale
timeFrame: 2 weeks post treatment
measure: Pain Level as Assessed by a Visual Analogue Scale
timeFrame: 3 weeks post treatment
measure: Pain Level as Assessed by a Visual Analogue Scale
timeFrame: 4 weeks post treatment
measure: Number of Participants who had a second visit to a Emergency Department or Clinic
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kimberly A Chambers, MD
role: PRINCIPAL_INVESTIGATOR
References: