Clinical trial NCT04763876: Intramuscular Ketorolac at Two Single-Dose Regimens
Official title: Comparison of Intramuscular Ketorolac at Two Single-Dose Regimens for Treatment of Acute Musculoskeletal Pain in a Military Emergency Department: A Randomized Controlled Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Musculoskeletal Pain
Analgesia
Adverse Event
Keywords: emergency department
ketorolac
musculoskeletal pain
non-inferiority
adverse event
Lead sponsor: William Beaumont Army Medical Center
Sponsor class: FED
First posted: 2021-02-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded, randomized, non-inferiority
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate a single 15 mg intramuscular (IM) dose of ketorolac for analgesic non-inferiority versus a single 60 mg IM dose for the treatment of acute MSK pain in a military emergency department (ED) that services Department of Defense (DoD), Department of Veteran Affairs (VA), and foreign military beneficiaries

Detailed description: The primary purpose of this study is to evaluate a single 15 mg IM dose of ketorolac for analgesic non-inferiority versus a single 60 mg IM dose for the treatment of acute MSK pain in a military ED that services Department of Defense (DoD), Department of Veteran Affairs (VA), and foreign military beneficiaries. The authors chose to evaluate 15 mg rather than the previously identified 10 mg dose for ease of administration as ketorolac is manufactured in 15 mg/mL, 30 mg/mL, and 60 mg/2mL vials in the U.S. The dose of ketorolac served as the primary independent variable for the study and the change in Visual Analog Scale (VAS) score served as the dependent variable. Prescribing the minimally effective doses of NSAIDs is pertinent to prevent and reduce the number of adverse events. Thus, the secondary outcome assessed for the dose-dependence of subjective and objective adverse events with ketorolac.

Eligibility criteria: Inclusion Criteria:

* Tricare beneficiaries between 18-55 years of age
* Triaged as Emergency Severity Index 4 or 5
* Presenting to the William Beaumont Army Medical Center Emergency Department with a chief complaint of acute MSK pain (i.e., general muscular, neck, back, shoulder, arm, forearm, elbow, wrist, finger, hip, knee, thigh, leg, ankle, foot, or digits)
* Pain intensity of 20 mm or greater on a standard 100 mm visual analog scale
* Who the attending provider concurred with ketorolac IM administration for analgesia.

Exclusion Criteria:

* Body weight less than 50 kg (110 lbs.)
* Younger than 18 or older than 55 years
* Pregnant or breast feeding
* History of: confirmed, unconfirmed, known, unknown, or suspected peptic ulcer disease, intestinal hemorrhage, renal insufficiency, hepatic insufficiency, cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, dark stools, bright red blood per rectum, hemoptysis, easy bruising, or high risk of bleeding
* Unable to confidently convey or unknown medical history
* Allergy or hypersensitivity to nonsteroidal anti-inflammatory drugs or aspirin
* Systolic blood pressure \<90 or \>180 mmHg
* Pulse rate \<50 or \>150 beats/min
* Any over-the-counter or prescribed opioid and/or non-opioid analgesic medication (oral, per rectum, topical or parenteral) taken within 12 hours of ED presentation
* Advised by any medical provider to not receive NSAIDs for any reason
* Pain duration greater than 30 days (including acute on chronic pain)
* Refusal to remain in the WBAMC ED for up to 60 minutes after injection of ketorolac
* Patients currently taking anticoagulant medications
* Concurrent use of medications which are contraindicated with concomitant NSAID use (drugs include aspirin, probenecid and pentoxifylline).

Primary outcomes:
measure: Mean difference of Visual Analog Scale scores between the two groups
timeFrame: 60 minutes from administration of medication
Secondary outcomes:
measure: Mean difference of Visual Analog Scale scores between the two groups
timeFrame: 30 minutes from administration of medication
measure: Incidence of adverse events related to the administration of ketorolac
timeFrame: At time of administration, 30 minutes after administration, and 60 minutes after administration.
Other outcomes:
Locations:
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
Study officials:
affiliation: Department of Emergency Medicine, William Beaumont Army Medical Center
name: Nathaniel J Turner, MPAS
role: PRINCIPAL_INVESTIGATOR
References: