Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201676
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2023-12-16
Brief Title:
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 polytrauma patients The main questions this study aims to answer are
1 Are patients who are given scheduled ketorolac during the first five hospital days less likely to develop chronic opioid use at 6 months after injury compared to patients who receive placebo
2 Does scheduled ketorolac during the first five hospital days 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 placebo group to be given every 6 hours during the first five hospital days 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 ketorolac treatment versus saline placebo to see if ketorolac reduces chronic opioid use and improves the functional response to pain
1 Are patients who are given scheduled ketorolac during the first five hospital days less likely to develop chronic opioid use at 6 months after injury compared to patients who receive placebo
2 Does scheduled ketorolac during the first five hospital days 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 placebo group to be given every 6 hours during the first five hospital days 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 ketorolac treatment versus saline placebo to see if ketorolac reduces chronic opioid use and improves the functional response to pain
Detailed Description:
Background Post-traumatic pain PTP can be difficult to control in polytrauma patients Currently opioids serve as the cornerstone for pain management despite their potential for complications including chronic use Given this it is not surprising that new-onset opioid abuse is a leading cause of complications following polytrauma and can be a limiting factor in delaying andor safely resuming pre-injury responsibilities Changes in pain management are needed to help military personnel and civilians expeditiously and safely return to their pre-injury duty Early short-term scheduled ketorolac treatment has been shown to decrease acute pain and short and mid-term opioid use but whether this translates into decreased chronic opioid use is unknown
HypothesisObjective This study attempts to determine whether an early scheduled short-term course of ketorolac treatment has a sustained impact by decreasing chronic opioid use The study will also investigate whether this treatment improves function and resilience as well as whether early pain control andor the functional response to pain mediate ie are responsible for explain the effect of the ketorolac intervention on chronic opioid use
Specific Aims
Aim 1 Determine whether orthopaedic polytrauma patients who receive IV ketorolac 15 mg every six hours in combination with standard of care SOC analgesia for the first five inpatient days are less likely to develop chronic opioid use defined as continued use at six months post-injury compared to patients receiving similar placebo injections in combination with SOC
Aim 2 Determine if patients who received a consistent five-day course of low-dose ketorolac during the inpatient stay have an improved functional response to pain measured via 1 Brief Pain Inventory BPI 2 Patient-Reported Outcomes Measurement Information System - Pain Interference PROMIS-PI and 3 Brief Resilience Scale BRS scores at discharge 3 months and 6 months post-injury Secondary pain outcome measures such as pain VAS and MME data will also be compared between the two groups
Aim 3 Determine 1 the extent to which early pain control during the intervention assessed using pain VAS and MME intake mediates the effect of ketorolac on chronic opioid use 2 the extent to which early pain control mediates the effect of ketorolac on the functional response to pain measures assessed using BPI PROMIS-PI and BRS and 3 the extent to which early pain control and the functional response to pain in combination or isolation mediate the effect of ketorolac on chronic opioid use
Study Design Polytrauma patients aged 18 to 70 years of age with a New Injury Severity Score greater than 9 consistent with moderate injury and anticipated admission of at least 5 days to ensure completion of the treatment will be enrolled Once enrolled patient randomization will be stratified by site and NISS score categorization either 10-15 or greater than 15 Experienced clinical research staff will prospectively identify patients with strict adherence to all inclusion and exclusion criteria Participants will be randomized to treatment 15 mg of ketorolac plus SOC multimodal analgesia every 6 hours for 5 days or control similar volume of saline every 6 hours plus SOC multimodal analgesia for 5 days Measures of the functional response to pain including the BPI PROMIS-PI and BRS will be collected at hospital discharge and 3- and 6-months post-injury Outcome measures of pain including VAS and MME will be recorded at enrollment during the first five days of inpatient admission at discharge and at clinic follow-ups The treatment and control groups will be compared using the intention-to-treat analyses across the primary and secondary outcomes Mediation analyses will be used to understand how early pain control and the functional response to pain mediate the effect or lack of effect on chronic opioid use to better understand the factors that lead to this devastating complication
HypothesisObjective This study attempts to determine whether an early scheduled short-term course of ketorolac treatment has a sustained impact by decreasing chronic opioid use The study will also investigate whether this treatment improves function and resilience as well as whether early pain control andor the functional response to pain mediate ie are responsible for explain the effect of the ketorolac intervention on chronic opioid use
Specific Aims
Aim 1 Determine whether orthopaedic polytrauma patients who receive IV ketorolac 15 mg every six hours in combination with standard of care SOC analgesia for the first five inpatient days are less likely to develop chronic opioid use defined as continued use at six months post-injury compared to patients receiving similar placebo injections in combination with SOC
Aim 2 Determine if patients who received a consistent five-day course of low-dose ketorolac during the inpatient stay have an improved functional response to pain measured via 1 Brief Pain Inventory BPI 2 Patient-Reported Outcomes Measurement Information System - Pain Interference PROMIS-PI and 3 Brief Resilience Scale BRS scores at discharge 3 months and 6 months post-injury Secondary pain outcome measures such as pain VAS and MME data will also be compared between the two groups
Aim 3 Determine 1 the extent to which early pain control during the intervention assessed using pain VAS and MME intake mediates the effect of ketorolac on chronic opioid use 2 the extent to which early pain control mediates the effect of ketorolac on the functional response to pain measures assessed using BPI PROMIS-PI and BRS and 3 the extent to which early pain control and the functional response to pain in combination or isolation mediate the effect of ketorolac on chronic opioid use
Study Design Polytrauma patients aged 18 to 70 years of age with a New Injury Severity Score greater than 9 consistent with moderate injury and anticipated admission of at least 5 days to ensure completion of the treatment will be enrolled Once enrolled patient randomization will be stratified by site and NISS score categorization either 10-15 or greater than 15 Experienced clinical research staff will prospectively identify patients with strict adherence to all inclusion and exclusion criteria Participants will be randomized to treatment 15 mg of ketorolac plus SOC multimodal analgesia every 6 hours for 5 days or control similar volume of saline every 6 hours plus SOC multimodal analgesia for 5 days Measures of the functional response to pain including the BPI PROMIS-PI and BRS will be collected at hospital discharge and 3- and 6-months post-injury Outcome measures of pain including VAS and MME will be recorded at enrollment during the first five days of inpatient admission at discharge and at clinic follow-ups The treatment and control groups will be compared using the intention-to-treat analyses across the primary and secondary outcomes Mediation analyses will be used to understand how early pain control and the functional response to pain mediate the effect or lack of effect on chronic opioid use to better understand the factors that lead to this devastating complication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HT9425-23-1-0413 | OTHER_GRANT | Department of Defense PRORP | None |