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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to up to 15 minutes after ets

Awards & highlights

Study Summary

This trial studies the effect of nebulized lidocaine, instilled lidocaine, and instilled saline to reduce intracranial pressure in children w/ severe head injuries.

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.Check my eligibility

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.See study design

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to upto 15 minutes after ets

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to upto 15 minutes after ets

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692

40%

Nausea

10%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Tumescent Solution With Dilute Epinephrine

Tumescent Solution With Dilute Lidocaine and Epinephrine

Trial Design

6Treatment groups

Experimental Treatment

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