Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMassachusetts General Hospital
About this trial
The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic trauma patients. The main questions this study aims to answer are:
1. Are patients who are given scheduled ketorolac during the first five days of the perioperative period in combination with standard of care (SOC) multimodal analgesia (MMA) less likely to develop chronic opioid use at 6 months after injury compared to patients who SOC MMA alone? 2. Does scheduled ketorolac during the first five days of the perioperative period improve functional responses to pain at discharge, 3 months, and 6 months after injury? 3. Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both?
Participants will be enrolled and randomized to either the ketorolac (treatment) group or the SOC group. Patients randomized to the ketorolac group will receive ketorolac every 6 hours for up to five days during the perioperative period; patients discharged prior to completing the five-day regimen will complete the remainder of treatment with oral ketorolac. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury.
Researchers will compare patients receiving ketorolac (treatment) plus SOC versus those receiving SOC alone to determine if ketorolac reduces chronic opioid use and improves the functional response to pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age: 18-70
Patient or legally authorized representative (LAR) able to provide consent
Patients with acute musculoskeletal trauma requiring surgical fixation (i.e. ORIF with plates and screws and/or intramedullary nailing)
Anticipated hospital admission
Disqualifiers
Patient age < 18 or > 70 years
Patients with injury more than 24 hours prior to evaluation
Patients with active hemorrhagic shock or risk of significant hemorrhage
Patients who are pregnant or breastfeeding
Trial design
Design model
Parallel
Treatments tested in this trial
Ketorolac Injection
DrugKetorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity in animal models. The mechanism of action of ketorolac, like that of other NSAIDs, is not completely understood but may be related to prostaglandin Reference ID: 3281582 3 synthetase inhibition. The biological activity of ketorolac tromethamine is associated with the S-form. Ketorolac tromethamine possesses no sedative or anxiolytic properties.
Standard of Care (SOC) Multimodal Analgesia
Other interventionStandard of care (SOC) multimodal analgesia as determined by each participating site's institutional protocol for perioperative pain management in orthopaedic trauma patients. SOC may include opioids, acetaminophen, regional anesthesia, and other non-NSAID analgesic modalities. Scheduled nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac, are not permitted during the five-day perioperative treatment period.
Treatment groups
458 Participants
are divided into 2 treatment groupsGroup A: Standard of Care (SOC) + KetorolacExperimental treatment 2 interventions
Group B: Standard of Care (SOC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Chronic Opioid Use
Defined as continued opioid use at 6 months post-trauma
Time frame
6 monthsSecondary outcomes
1
Brief Pain Inventory (BPI)
Pain assessment tool that measures both the intensity of pain and interference of pain in a patient's life, including pain relief, pain quality, and patient perception of pain. Each question is scaled from 0 to 10, with a higher score meaning worse pain.
Time frame
Enrollment, Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma2
Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI)
NIH-validated outcome measure that assesses how pain interferes with a patient's daily activities. This is measured using a T-score metric in which 50 is the mean of a relevant reference population, and 10 is the standard deviation of the population. A higher score for this survey means a worse outcome and is representative of pain interfering more in a patient's daily activities.
Time frame
Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma3
Brief Resilience Scale (BRS)
Scale developed to assess a patient's ability to bounce back or recover from stress. This scale consists of 6 questions with answer choices ranging from 1-5. The total score is calculated and averaged to reflect the BRS score. BRS scores from 1.00 - 2.99 reflect low resilience, 3.00 - 4.30 reflect normal resilience, and scores from 4.31 - 5.00 reflect high resilience.
Time frame
Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-trauma4
Visual Analogue Scale (VAS)
Instrument that attempts to capture a patient's perception of pain along a continuum. This will be measured on a scale of 0 - 100, with 0 being no pain, 50 being moderate pain, and 100 being the worst pain possible.
Time frame
Enrollment, First Five Hospital Days, Hospital Discharge (up to 2 weeks), 2 weeks, 6 weeks, 3 months, and 6 months post-traumaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov