Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury

Summary

The purpose of this study is to evaluate the effectiveness of nebulized lidocaine before Endotracheal suctioning (ETS) compared to instilled lidocaine and the effectiveness of aerosolized lidocaine versus instilled normal saline before ETS in attenuating the increase of intracranial pressure (ICP) in severe head injured children and to evaluate the feasibility of a trial involving instilled lidocaine and aerosolized lidocaine for the management of ETS and to evaluate the safety of nebulized lidocaine in traumatic brain injury (TBI) compared to instilled lidocaine and instilled sodium chloride (NS).

Conditions

• Traumatic Brain Injury

Interventions

DRUG

aerosolized 2% lidocaine (20mg/ml)

The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.

DRUG

instilled 0.9% sodium chloride (NS)

The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.

DRUG

instilled 2% lidocaine solution

The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.

PROCEDURE

Endotracheal Suctioning (ETS)

ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Thao L Nguyen, DO, FAAP · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-09

Primary Completion

2025-06-30

Completion

2025-06-30

FDA Drug

Yes

Countries

• United States

Study Locations