Nebulized Lidocaine for Traumatic Brain Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether nebulized lidocaine, a numbing medicine, can safely and effectively manage increased pressure inside the skull during a specific procedure for children with serious head injuries. Researchers compare it with other forms of lidocaine (including aerosolized lidocaine, endotracheal lidocaine, and lidocaine solution) and a saline solution to determine which best controls this pressure. Children with severe traumatic brain injury, who are in the ICU and on a breathing machine, might be suitable for this study. As a Phase 4 trial, this research aims to understand how an FDA-approved and effective treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that both aerosolized and endotracheal lidocaine are generally safe for managing intracranial pressure in patients with traumatic brain injury. Studies have found that lidocaine, whether inhaled as a mist or administered directly into the windpipe, can help prevent pressure spikes during procedures like mucus removal from the windpipe.
For aerosolized lidocaine, specific evidence for traumatic brain injury is limited, but it is often used in similar cases without major safety issues. Lidocaine's FDA approval for other uses indicates its general safety.
Endotracheal lidocaine has been used in traumatic brain injury cases to reduce stress during intubation, effectively preventing increases in intracranial pressure. Safety data supports its use.
In summary, both methods of administering lidocaine appear safe for managing brain pressure, with no major side effects reported in the available data.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using nebulized lidocaine for traumatic brain injury because it offers a unique delivery method that could provide quick pain relief and reduce inflammation directly at the site. Unlike standard treatments that often involve systemic pain relief methods, nebulized lidocaine delivers the medication as an aerosol, potentially leading to faster and more targeted effects. This approach could minimize side effects and offer a non-invasive option for managing symptoms, making it a promising advancement in treating traumatic brain injuries.
What evidence suggests that this trial's treatments could be effective for traumatic brain injury?
Research shows that aerosolized lidocaine, one of the treatments in this trial, can help prevent increases in brain pressure during endotracheal suctioning. This is crucial for individuals with serious head injuries, as it prevents excessive pressure rise. Studies have found that aerosolized lidocaine does not affect other vital body functions and is safe for deeply sedated patients.
Similarly, endotracheal lidocaine, another treatment option in this trial, effectively prevents spikes in brain pressure during the same procedure. Both forms of lidocaine in this trial manage brain pressure, which is essential for treating severe head injuries. These treatments have been used to control brain pressure during medical procedures, supporting their expected effectiveness.12367Who Is on the Research Team?
Thao L Nguyen, DO, FAAP
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for children with severe traumatic brain injury (TBI), who are intubated, ventilated, and have an ICP monitor. They must be stable with normal blood pressure or maintained on norepinephrine to keep proper cerebral blood flow. It's not for those with uncontrollable high ICP, severe lung issues like ARDS or bleeding, muscle paralysis treatments, or other types of shock.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive aerosolized lidocaine, instilled lidocaine, and instilled saline solution before endotracheal suctioning to evaluate the effectiveness and safety in managing intracranial pressure spikes.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including measuring intracranial pressure and respiratory dynamics.
What Are the Treatments Tested in This Trial?
Interventions
- Aerosolized Lidocaine
- Endotracheal Lidocaine
- Lidocaine Solution
- Sodium Chloride
Aerosolized Lidocaine is already approved in European Union, United States, Canada for the following indications:
- Local anesthesia
- Arrhythmias
- Epilepsy
- Severe traumatic brain injury for endotracheal suctioning
- Local anesthesia
- Arrhythmias
- Epilepsy
- Severe traumatic brain injury for endotracheal suctioning
- Local anesthesia
- Arrhythmias
- Epilepsy
- Severe traumatic brain injury for endotracheal suctioning
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor