Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04781673
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2021-02-22
Brief Title:
Ketamine vs Lidocaine in Traumatic Rib Fractures
Sponsor:
Brittany Hoyte
Organization:
Spectrum Health Hospitals
Study Overview
Official Title:
A Prospective Randomized Single-Blinded Trial of Ketamine Versus Lidocaine Infusions for Multimodal Pain Management in Traumatic Rib Fracture Patients
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Rib fractures continue to be a common occurrence in trauma patients of all ages Traumatic rib fractures can cause severe pain in patients and lead to shallow breathing and further complications such as the need for mechanical ventilation hospital or ventilator associated pneumonia atelectasis and acute respiratory distress syndrome Effective multimodal pain management is needed to optimize a patients respiratory status and can also play a role in early mobility less pulmonary complications shorter ICU and hospital length of stay and decreased mortality Current multimodal pain management options include opioids muscle relaxants gabapentin acetaminophen nonsteroidal anti-inflammatory drugs and various regionalneuraxial anesthesia techniques Both ketamine and lidocaine infusions for pain control have also been shown in studies to be safe and effective with the benefit of minimizing the use of opioids However there have been very few studies that have used ketamine or lidocaine infusions for pain control specifically in patients with traumatic rib fractures Therefore the purpose of this study is to evaluate ketamine versus lidocaine infusions as an adjunctive therapy to reduce opioid consumption in the first 72 hours in patients with multiple traumatic rib fractures
Detailed Description:
Effective pain control plays a key role is optimizing a patients respiratory status after suffering multiple rib fractures Using multimodal pain management techniques and optimizing a patients pain control regimen helps to minimize the complications associated with rib fractures such as pneumonia and the need for mechanical ventilation The benefit of using opioid-sparing options such as ketamine or lidocaine infusions would be to avoid the side effects associated with opioids which include delirium constipation and depressed respiratory drive
Ketamine and lidocaine infusions are both medications that have been used in numerous studies to effectively treat post-operative pain Low dose ketamine infusions have also recently been shown to be a safe and effective adjunct option to help reduce pain scores and decrease opioid use in patients with traumatic rib fractures Currently there is no published studies to assess lidocaines effectiveness to reduce pain scores and opioid use in traumatic rib fracture patients There is also only one study to date that has directly compared ketamine to lidocaine infusions for pain control This study occurred in 60 patients undergoing elective nephrectomy and evaluated three 24-hour infusion groups ketamine lidocaine or placebo The primary outcome showed that both ketamine and lidocaine infusions significantly reduced 24-hour OME compared to placebo 33 ketamine 42 lidocaine and decreased overall pain scores
This trial is a single center prospective randomized trial of adult patients with 3 traumatic rib fractures admitted to a Level 1 trauma center at Spectrum Health Butterworth Hospital As part of the current rib fracture protocol all patients will receive the standard multimodal pain regimen at the investigators institution including acetaminophen NSAIDS muscle relaxants and gabapentin Currently ketamine infusions and regionalneuraxial anesthesia techniques are added if the standard multimodal pain regimen is insufficient Lidocaine infusions have also been used at the institution for post-surgical pain control to minimize opioid use The objective of the study will be to compare ketamine versus lidocaine infusions on the effectiveness to optimize pain control as well as minimize the use of opioids in patients with traumatic rib fractures
If consent is obtained the patient will be randomized 11 to receive either a ketamine or lidocaine infusion for pain control along with standard of care using a pre-designed randomization schedule Patients must be enrolled within 16 hours of hospital admission and are expected to remain on the infusion for a minimum of 24 hours The duration titration and stopping of study drug will be dependent on the progress of the patients overall pain status and provider decision with data being included for the study medication for up to 72 hours If patients require surgery at any time the study medication will not be held unless signs of adverse events occur Patients who are unable to remain on the study infusion or have a regionalneuraxial anesthetic placed before the 24-hour mark decided based on the Trauma and Surgical Intensive Care Unit services will be considered a screen fail and no data will be contributed to the study however the screen fail will be documented If a patient is unable to remain on infusion or has a regionalneuraxial anesthetic placed 24 hours their data will be included up until that point and analyzed Adverse event and serious adverse events will be monitored throughout the entire study period with continuous cardiac telemetry being required in both study groups and daily lidocaine levels drawn in the lidocaine group
Ketamine and lidocaine infusions are both medications that have been used in numerous studies to effectively treat post-operative pain Low dose ketamine infusions have also recently been shown to be a safe and effective adjunct option to help reduce pain scores and decrease opioid use in patients with traumatic rib fractures Currently there is no published studies to assess lidocaines effectiveness to reduce pain scores and opioid use in traumatic rib fracture patients There is also only one study to date that has directly compared ketamine to lidocaine infusions for pain control This study occurred in 60 patients undergoing elective nephrectomy and evaluated three 24-hour infusion groups ketamine lidocaine or placebo The primary outcome showed that both ketamine and lidocaine infusions significantly reduced 24-hour OME compared to placebo 33 ketamine 42 lidocaine and decreased overall pain scores
This trial is a single center prospective randomized trial of adult patients with 3 traumatic rib fractures admitted to a Level 1 trauma center at Spectrum Health Butterworth Hospital As part of the current rib fracture protocol all patients will receive the standard multimodal pain regimen at the investigators institution including acetaminophen NSAIDS muscle relaxants and gabapentin Currently ketamine infusions and regionalneuraxial anesthesia techniques are added if the standard multimodal pain regimen is insufficient Lidocaine infusions have also been used at the institution for post-surgical pain control to minimize opioid use The objective of the study will be to compare ketamine versus lidocaine infusions on the effectiveness to optimize pain control as well as minimize the use of opioids in patients with traumatic rib fractures
If consent is obtained the patient will be randomized 11 to receive either a ketamine or lidocaine infusion for pain control along with standard of care using a pre-designed randomization schedule Patients must be enrolled within 16 hours of hospital admission and are expected to remain on the infusion for a minimum of 24 hours The duration titration and stopping of study drug will be dependent on the progress of the patients overall pain status and provider decision with data being included for the study medication for up to 72 hours If patients require surgery at any time the study medication will not be held unless signs of adverse events occur Patients who are unable to remain on the study infusion or have a regionalneuraxial anesthetic placed before the 24-hour mark decided based on the Trauma and Surgical Intensive Care Unit services will be considered a screen fail and no data will be contributed to the study however the screen fail will be documented If a patient is unable to remain on infusion or has a regionalneuraxial anesthetic placed 24 hours their data will be included up until that point and analyzed Adverse event and serious adverse events will be monitored throughout the entire study period with continuous cardiac telemetry being required in both study groups and daily lidocaine levels drawn in the lidocaine group
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