12 Participants Needed

Nebulized Lidocaine for Traumatic Brain Injury

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TL
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Overseen ByNikita Tripathi, MD
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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.12367

Who Is on the Research Team?

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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

Continuous invasive monitoring of arterial pressure
I am on a breathing machine and have a device monitoring my brain pressure.
Patients admitted to the PICU of Memorial Hermann Children's Hospital
See 2 more

Exclusion Criteria

I am using medication for shock not caused by an allergic reaction.
I am currently receiving treatment that affects my muscle function.
I have severe breathing problems with a high need for oxygen.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

Duration not specified
Multiple visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measuring intracranial pressure and respiratory dynamics.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aerosolized Lidocaine
  • Endotracheal Lidocaine
  • Lidocaine Solution
  • Sodium Chloride
Trial Overview The study tests if nebulized lidocaine can better prevent spikes in brain pressure during suctioning compared to directly instilled lidocaine or saline solution. The goal is to see which method is more effective and safe for managing airway procedures in kids with serious head injuries.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: aerosolized lidocaine then instilled saline solution then Instilled lidocaine solutionExperimental Treatment4 Interventions
Group II: aerosolized lidocaine then Instilled lidocaine solution then instilled saline solutionExperimental Treatment4 Interventions
Group III: Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solutionExperimental Treatment4 Interventions
Group IV: Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaineExperimental Treatment4 Interventions
Group V: Instilled lidocaine solution then instilled saline solution then aerosolized lidocaineExperimental Treatment4 Interventions
Group VI: Instilled lidocaine solution then aerosolized lidocaine then instilled saline solutionExperimental Treatment4 Interventions

Aerosolized Lidocaine is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Lidocaine for:
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Approved in United States as Lidocaine for:
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Approved in Canada as Lidocaine for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Published Research Related to This Trial

Articaine is an effective and well-tolerated anesthetic for dental procedures, making it a suitable substitute for lignocaine based on a focused literature review.
There is a potential, though unproven, concern regarding a link between 4% concentrations of articaine and nerve damage, which practitioners should be aware of when using this anesthetic.
Articaine hydrochloride: a safe alternative to lignocaine?Wells, JP., Beckett, H.[2018]
In a study involving six RAO-susceptible horses, lidocaine infusion did not reduce neutrophilic inflammation in the airways, as measured by bronchoalveolar lavage fluid (BALF) cytology.
While lidocaine increased the total cell count in BALF, it did not significantly affect the percentage of neutrophils or improve clinical scores compared to the control treatment, indicating that lidocaine may not be effective for managing neutrophilic inflammation in RAO.
The effect of intravenous lidocaine infusion on bronchoalveolar lavage cytology in equine recurrent airway obstruction.Wilson, ME., Berney, C., Behan, AL., et al.[2016]
Pretreatment with lignocaine (lidocaine) may help reduce the increase in intracranial pressure during intubation in patients with head injuries, based on a review of three key studies.
The review analyzed 85 papers but focused on the three that provided the strongest evidence, highlighting the importance of careful selection of studies in clinical decision-making.
Towards evidence based emergency medicine: best BETs from Manchester Royal Infirmary. Lignocaine premedication before rapid sequence induction in head injuries.Butler, J., Jackson, R.[2019]

Citations

Aerosolized Endotracheal Lidocaine to Avoid Intracranial ...The purpose of this study is to evaluate the effectiveness of nebulized lidocaine before Endotracheal suctioning (ETS) compared to instilled lidocaine and the ...
Evaluation of the Effect of Intranasal Lidocaine in the ...According to the findings of this study, continuous intranasal infusion of lidocaine appears to be effective in patients with spasticity caused by TBI. It is ...
Nebulized Lidocaine for Traumatic Brain InjuryThere is no direct evidence from the provided research articles supporting the effectiveness of nebulized lidocaine for traumatic brain injury. However, ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/22990390/
Aerosolized lidocaine during invasive mechanical ventilationAerosolized lidocaine (2 mg/kg) can prevent ETS-induced increases in ICP, without modifying systemic and cerebral hemodynamics in deeply sedated patients.
Aerosolized Endotracheal Lidocaine to Avoid Intracranial ...The purpose of this study is to evaluate the effectiveness of nebulized lidocaine before Endotracheal suctioning (ETS) compared to instilled ...
Trial | NCT05058677Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury ... safety of nebulized lidocaine ...
Current Clinical Trials in Traumatic Brain Injury - PMCOf the 44 studies, 30 showed no statistical difference between treatment and controls, 7 studies showed better results in the treatment arm but lacked ...
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