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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aerosolized lidocaine then Instilled lidocaine solution then instilled saline solution | Experimental | Treatment will be performed before the endotracheal suctioning |
|
| aerosolized lidocaine then instilled saline solution then Instilled lidocaine solution | Experimental | Treatment will be performed before the endotracheal suctioning |
|
| Instilled lidocaine solution then aerosolized lidocaine then instilled saline solution | Experimental | Treatment will be performed before the endotracheal suctioning |
|
| Instilled lidocaine solution then instilled saline solution then aerosolized lidocaine | Experimental | Treatment will be performed before the endotracheal suctioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aerosolized 2% lidocaine (20mg/ml) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine | A Codman Intraparenchymal Catheter will measure the ICP.The ICP will be transduced and measured numerically and continuously in real time on the patient's bedside monitor. | from baseline to upto 15 minutes after ETS |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in nebulized lidocaine and normal saline | A Codman Intraparenchymal Catheter will measure the ICP.The ICP will be transduced and measured numerically and continuously in real time on the patient's bedside monitor. | from baseline to up to 15 minutes after ETS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thao L Nguyen, DO, FAAP | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| Instilled saline solution then aerosolized lidocaine then Instilled lidocaine solution | Experimental | Treatment will be performed before the endotracheal suctioning |
|
| Instilled saline solution then Instilled lidocaine solution then aerosolized lidocaine | Experimental | Treatment will be performed before the endotracheal suctioning |
|
|
| instilled 0.9% sodium chloride (NS) | Drug | 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. |
|
| instilled 2% lidocaine solution | Drug | 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. |
|
| Endotracheal Suctioning (ETS) | Procedure | 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). |
|
| Number of patients with worsening respiratory dynamics | This will be measured by increasing oxygenation index or worsening compliance, measured by any increase in the peak pressure for volume ventilated patients. | from baseline to up to 15 minutes after ETS |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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