What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) using local anesthetics like nebulized lidocaine can cause side effects such as local irritation, numbness, and allergic reactions. Systemic absorption of lidocaine may lead to dizziness, headache, hypotension, bradycardia, and in severe cases, central nervous system toxicity, including seizures or cardiac arrhythmias. These side effects are typically rare when administered in a controlled medical environment.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Traumatic Brain Injury (TBI) that are directly analogous to nebulized lidocaine. Treatments for TBI generally focus on managing symptoms and preventing secondary injury, including the use of diuretics, anti-seizure drugs, and coma-inducing drugs. Nebulized lidocaine, which is being studied for its potential to reduce intracranial pressure spikes during endotracheal suctioning, represents a novel approach that has not yet been approved by the FDA for this specific use.

What other types of research exist?

Promising novel alternatives to nebulized lidocaine for TBI patients in 2024 include liposomal bupivacaine, which offers prolonged analgesic effects, and transdermal drug delivery systems that provide consistent and controlled local anesthetic release. Additionally, non-pharmacological approaches such as high-frequency chest wall oscillation (HFCWO) and mechanical insufflation-exsufflation (MI-E) devices may reduce the need for ETS and associated pain.

← Back to Search

Local Anesthetic

Nebulized Lidocaine for Traumatic Brain Injury

Phase 4

Recruiting

Led By Thao L Nguyen, DO, FAAP

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intubated and mechanically ventilated with an ICP monitor in place

Severe TBI with a Glasgow Coma Scale score 4-8

Must not have

Use of other vasopressors for other causes of shock (cardiogenic, hypovolemic and septic)

Patients receiving neuromuscular blockade

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to upto 15 minutes after ets

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests different ways of giving lidocaine (as a mist or directly) and compares it to saltwater. It focuses on children with severe head injuries who need a procedure that can increase head pressure. Lidocaine might help reduce this pressure and make the procedure safer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include local irritation from the aerosolized medication, changes in heart rate or blood pressure due to the lidocaine absorption into the bloodstream, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on a breathing machine and have a device monitoring my brain pressure.

Select...

I have a severe brain injury with a low consciousness level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am using medication for shock not caused by an allergic reaction.

Select...

I am currently receiving treatment that affects my muscle function.

Select...

I have severe breathing problems with a high need for oxygen.

Select...

I have had bleeding in my lungs.

Select...

My brain pressure remained high despite treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to up to 15 minutes after ets

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to up to 15 minutes after ets

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to up to 15 minutes after ets for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine

Secondary study objectives

Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in nebulized lidocaine and normal saline

Number of patients with worsening respiratory dynamics

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Group I: aerosolized lidocaine then instilled saline solution then Instilled lidocaine solutionExperimental Treatment4 Interventions