Nebulized Lidocaine for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Overseen by Thao L Nguyen, DO, FAAP

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Neuromuscular blockers, Other vasopressors

Disqualifiers: Sustained ICP, ARDS, Pulmonary hemorrhage, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug nebulized lidocaine for traumatic brain injury?

There is no direct evidence from the provided research articles supporting the effectiveness of nebulized lidocaine for traumatic brain injury. However, lidocaine has been shown to be effective as a local anesthetic in other medical procedures, such as fiberoptic bronchoscopy and post-episiotomy pain relief. ^{1 2 3 4 5}

Is nebulized lidocaine safe for use in humans?

Lidocaine, also known as lignocaine, has been used safely in various forms for different medical procedures, such as anesthesia during flexible bronchoscopy and pain relief after episiotomy. Some studies have shown it can cause mild side effects like stinging, but overall, it is generally well-tolerated in humans. ^{1 6 7 8 9}

How does the drug nebulized lidocaine differ from other treatments for traumatic brain injury?

Nebulized lidocaine is unique because it is administered as an aerosol, allowing it to reach the lungs and potentially reduce inflammation and intracranial pressure, which is different from traditional treatments that may not target these specific mechanisms. ^{9 10 11 12 13}

Research Team

Thao L Nguyen, DO, FAAP

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Aerosolized Lidocaine (Local Anesthetic)
• Endotracheal Lidocaine (Local Anesthetic)
• Lidocaine Solution (Local Anesthetic)
• Sodium Chloride (Drug)

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.

Participant Groups

Group I: aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution Experimental Treatment 4 Interventions

Treatment will be performed before the endotracheal suctioning

Group II: aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution Experimental Treatment 4 Interventions

Treatment will be performed before the endotracheal suctioning

Group III: Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution Experimental Treatment 4 Interventions

Treatment will be performed before the endotracheal suctioning

Group IV: Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine Experimental Treatment 4 Interventions

Treatment will be performed before the endotracheal suctioning

Group V: Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine Experimental Treatment 4 Interventions

Treatment will be performed before the endotracheal suctioning

Group VI: Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution Experimental Treatment 4 Interventions

Treatment will be performed before the endotracheal suctioning

Aerosolized Lidocaine is already approved in Canada for the following indications:

Approved in Canada as Lidocaine for:

• Local anesthesia
• Arrhythmias
• Epilepsy
• Severe traumatic brain injury for endotracheal suctioning

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD

Findings from Research

In a study of 76 women with post-episiotomy pain, both lignocaine (5%) and cinchocaine (2%) aerosol sprays provided significant pain relief compared to a placebo, with lignocaine being the more effective option.

The only reported side effect was slight stinging from the lignocaine spray, and serum levels of the local anesthetic were negligible, indicating a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of two local anaesthetic sprays for the relief of post-episiotomy pain. Harrison, RF., Brennan, M.[2019]

In a study of 12 patients undergoing fiberoptic bronchoscopy, peak plasma concentrations of lignocaine were observed 20-30 minutes after administration, with no patients exceeding the critical toxicity level of 5 microg/ml despite using a total dose that exceeded the recommended maximum of 400 mg.

The study found a significant correlation between the total and tracheobronchial doses of lignocaine and peak serum concentration, but no correlation with the nasal anesthesia dose, indicating that nasal administration may not significantly impact systemic absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum concentrations of lignocaine before, during and after fiberoptic bronchoscopy. Loukides, S., Katsoulis, K., Tsarpalis, K., et al.[2017]

The study demonstrated that aerosolized lignocaine 2% administered to the nose, pharynx, and larynx effectively facilitated intubation in 10 unsedated volunteers, with a mean intubation time of 12 minutes.

The procedure was safe, with lignocaine doses well below toxic levels and no adverse effects such as oxyhaemoglobin desaturation, indicating good hemodynamic stability during the intubation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awake intubation made easy and acceptable. Jenkins, SA., Marshall, CF.[2019]

In a study of 126 patients, using 2% lignocaine gel as a lubricant for the laryngeal mask airway resulted in significantly more intra- and postoperative complications compared to saline (p < 0.05).

Despite the complications, both lignocaine and saline lubricants had similar rates of sore throat, especially when the device was successfully inserted on the first attempt, indicating that lignocaine gel is not a suitable lubricant for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laryngeal mask lubrication. A comparative study of saline versus 2% lignocaine gel with cuff pressure control. Keller, C., Sparr, HJ., Brimacombe, JR.[2019]

In a randomized, placebo-controlled study involving patients undergoing flexible fibreoptic bronchoscopy, additional nebulised lignocaine did not significantly improve the ease of the procedure or reduce cough severity compared to standard lignocaine administration.

The study suggests that current preparation methods for bronchoscopic examinations may need to be optimized, as the addition of nebulised lignocaine did not provide the expected benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy of nebulised lignocaine as adjunctive local anaesthesia for fibreoptic bronchoscopy: a randomised, placebo-controlled study. Charalampidou, S., Harris, E., Chummun, K., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Articaine hydrochloride: a safe alternative to lignocaine? Wells, JP., Beckett, H.[2018]

Topical laryngeal lignocaine is commonly used in pediatric anesthesia to help with airway procedures and reduce respiratory complications, but studies show mixed results regarding its safety and effectiveness.

There is insufficient evidence on the optimal dosage, effects on swallowing, and the duration of airway reflex suppression, highlighting the need for further research to ensure safe use in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lignocaine topicalization of the pediatric airway. Roberts, MH., Gildersleve, CD.[2016]

In a study involving 500 patients undergoing flexible bronchoscopy, 1% lignocaine was found to be as effective as 2% lignocaine for topical anesthesia, but with a significantly lower cumulative dose required.

The use of 2% lignocaine resulted in a higher risk of exceeding the maximum recommended dose, with 28% of patients in that group surpassing safe limits, although no adverse events were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of 1% vs 2% Lignocaine by the Spray-as-You-Go Technique for Topical Anesthesia During Flexible Bronchoscopy. Kaur, H., Dhooria, S., Aggarwal, AN., et al.[2022]

In a study involving 60 adult patients with temporomandibular joint ankylosis, both 2% lignocaine nebulization and the spray-as-you-go technique were found to provide effective airway anesthesia for awake flexible fiberoptic intubation.

There were no significant differences in patient comfort or hemodynamic changes between the two methods, indicating that both techniques are equally acceptable for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nebulisation Versus Spray-as-You-Go Airway Topical Anaesthesia in Patients with Temporomandibular Joint Ankylosis using 2 % Lignocaine. Dhasmana, S., Singh, V., Pal, US.[2020]

The study tested whether dyspnoea (difficulty breathing) could be influenced by unmyelinated vagal sensory nerve endings in the lungs, using a modified nebulizer to deliver small-particle aerosols of lignocaine (local anaesthetic) to the alveoli.

In a clinical trial with six patients, while lignocaine did not show a significant overall effect on dyspnoea, some individual patients experienced benefits, indicating potential variability in response to the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of small-particle aerosols of local anaesthetic on dyspnoea in patients with respiratory disease. Stark, RD., O'Neill, PA., Russell, NJ., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 65 cardiac surgery patients, those receiving lidocaine showed significantly better outcomes in neuropsychological tests compared to those receiving a placebo, particularly at 10 days and 10 weeks post-surgery.

Lidocaine's protective effects on cognitive function were evident in 6 out of 11 neuropsychological tests and in memory assessments, indicating its potential as a beneficial intervention during cardiac operations, independent of its effects on depression and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral protection by lidocaine during cardiac operations. Mitchell, SJ., Pellett, O., Gorman, DF.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of two local anaesthetic sprays for the relief of post-episiotomy pain. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Serum concentrations of lignocaine before, during and after fiberoptic bronchoscopy. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Awake intubation made easy and acceptable. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Laryngeal mask lubrication. A comparative study of saline versus 2% lignocaine gel with cuff pressure control. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy of nebulised lignocaine as adjunctive local anaesthesia for fibreoptic bronchoscopy: a randomised, placebo-controlled study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Articaine hydrochloride: a safe alternative to lignocaine? [2018]

7. France pubmed.ncbi.nlm.nih.gov

Lignocaine topicalization of the pediatric airway. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial of 1% vs 2% Lignocaine by the Spray-as-You-Go Technique for Topical Anesthesia During Flexible Bronchoscopy. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Nebulisation Versus Spray-as-You-Go Airway Topical Anaesthesia in Patients with Temporomandibular Joint Ankylosis using 2 % Lignocaine. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Effects of small-particle aerosols of local anaesthetic on dyspnoea in patients with respiratory disease. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The effect of intravenous lidocaine infusion on bronchoalveolar lavage cytology in equine recurrent airway obstruction. [2016]

12. England pubmed.ncbi.nlm.nih.gov

Towards evidence based emergency medicine: best BETs from Manchester Royal Infirmary. Lignocaine premedication before rapid sequence induction in head injuries. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Cerebral protection by lidocaine during cardiac operations. [2019]