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Intramuscular Ketorolac at Two Single-Dose Regimens

Primary Purpose

Musculoskeletal Pain, Analgesia, Adverse Event

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac Injection 15 mg
Ketorolac Injection 60 mg
Sponsored by
William Beaumont Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring emergency department, ketorolac, musculoskeletal pain, non-inferiority, adverse event

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • William Beaumont Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

15 mg ketorolac intramuscular

60 mg ketorolac intramuscular

Arm Description

Patients who received a single 15 mg dose of ketorolac administered intramuscularly

Patients who received a single 60 mg dose of ketorolac administered intramuscularly

Outcomes

Primary Outcome Measures

Mean difference of Visual Analog Scale scores between the two groups
The mean difference of Visual Analog Scale scores between the two treatment groups measured at 60-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.

Secondary Outcome Measures

Mean difference of Visual Analog Scale scores between the two groups
The mean difference of Visual Analog Scale scores between the two treatment groups measured at 60-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.
Incidence of adverse events related to the administration of ketorolac
The incidence of observed objective and reported subjective adverse events related to the administration of ketorolac.

Full Information

First Posted
February 1, 2021
Last Updated
February 18, 2021
Sponsor
William Beaumont Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04763876
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2020 (Actual)
Primary Completion Date
November 9, 2020 (Actual)
Study Completion Date
November 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Beaumont Army Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Analgesia, Adverse Event
Keywords
emergency department, ketorolac, musculoskeletal pain, non-inferiority, adverse event

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Single blinded, randomized, non-inferiority
Masking
Participant
Masking Description
The patient was unaware of the dosage of ketorolac they received.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15 mg ketorolac intramuscular
Arm Type
Active Comparator
Arm Description
Patients who received a single 15 mg dose of ketorolac administered intramuscularly
Arm Title
60 mg ketorolac intramuscular
Arm Type
Active Comparator
Arm Description
Patients who received a single 60 mg dose of ketorolac administered intramuscularly
Intervention Type
Drug
Intervention Name(s)
Ketorolac Injection 15 mg
Other Intervention Name(s)
toradol, ketorolac tromethamine, ketorolac
Intervention Description
A single dose of 15 mg ketorolac administered intramuscularly.
Intervention Type
Drug
Intervention Name(s)
Ketorolac Injection 60 mg
Other Intervention Name(s)
Toradol, ketorolac tromethamine, ketorolac
Intervention Description
A single dose of 60 mg ketorolac administered intramuscularly.
Primary Outcome Measure Information:
Title
Mean difference of Visual Analog Scale scores between the two groups
Description
The mean difference of Visual Analog Scale scores between the two treatment groups measured at 60-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.
Time Frame
60 minutes from administration of medication
Secondary Outcome Measure Information:
Title
Mean difference of Visual Analog Scale scores between the two groups
Description
The mean difference of Visual Analog Scale scores between the two treatment groups measured at 60-minutes. The Visual Analog Scale used measures from 0 mm to 100mm. A higher score represents more degree of change. 13 mm was used as the non-inferiority margin. A difference between the two groups less than 13 mm demonstrates that 15 mg is non-inferior to 60 mg.
Time Frame
30 minutes from administration of medication
Title
Incidence of adverse events related to the administration of ketorolac
Description
The incidence of observed objective and reported subjective adverse events related to the administration of ketorolac.
Time Frame
At time of administration, 30 minutes after administration, and 60 minutes after administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel J Turner, MPAS
Organizational Affiliation
Department of Emergency Medicine, William Beaumont Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Army Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Intramuscular Ketorolac at Two Single-Dose Regimens

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