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| Name | Class |
|---|---|
| Children's Hospital of Orange County | OTHER |
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Comparison of anesthetic efficacy of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (LET) applied three times for 10 minutes each time vs. once for 30 minutes prior to suturing simple lacerations in children aged 7-17 years.
Randomized single-blinded clinical trial with convenience sampling of the anesthetic efficacy of a single 30-minute application vs three 10-minute applications of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (LET) prior to suturing simple lacerations in children aged 7-17 years seen in the Emergency Department.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single LET | Active Comparator | One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes |
|
| Triple LET | Experimental | Three applications of LET topical gel, one applied every 10 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel | Drug | Topical anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Score | Pain score self-rated by patient on 100m Visual Analog Pain scale, minimum value 0, maximum value 100, higher scores equal more pain (worse outcome) | Immediately on placement or attempt at placement of first suture |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Additional Local Anesthetic | Need for additional infiltrated local anesthetic (lidocaine) | At any time during suturing procedure, time frame is duration of procedure, generally 10-20 minutes, less than one hour. Determined by chart review immediately after procedure completion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly D Young, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Orange County | Orange | California | 92868 | United States | ||
| Harbor-UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35100752 | Derived | Siembieda J, Heyming T, Padlipsky P, Young KD. Triple Versus Single Application of Lidocaine, Epinephrine, and Tetracaine for Laceration Repair in Children. Pediatr Emerg Care. 2022 Feb 1;38(2):e472-e474. doi: 10.1097/PEC.0000000000002631. |
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No plan
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Convenience sample, pediatric emergency departments at Harbor-UCLA Medical Center and Children's Hospital of Orange County
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| ID | Title | Description |
|---|---|---|
| FG000 | Single LET | One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic |
| FG001 | Triple LET | Three applications of LET topical gel, one applied every 10 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single LET | One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic |
| BG001 | Triple LET |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale Pain Score | Pain score self-rated by patient on 100m Visual Analog Pain scale, minimum value 0, maximum value 100, higher scores equal more pain (worse outcome) | Posted | Mean | Standard Deviation | mm | Immediately on placement or attempt at placement of first suture |
|
During the patient's emergency department visit until time of discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single LET | One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly D. Young, MD | Harbor-UCLA Medical Center | 424-306-5431 | kyoung3@dhs.lacounty.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2016 | Jan 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D013748 | Tetracaine |
| D005782 | Gels |
| D018499 | Linear Energy Transfer |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Single-blinded randomized study; patients are randomized to one of two groups
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Investigator and nurse applied intervention and masked the intervention from the care provider. Separate nurse not caring for the patient, blinded to the intervention, brought in to obtain pain score (outcome)
| Torrance |
| California |
| 90502 |
| United States |
Three applications of LET topical gel, one applied every 10 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Laceration location | Count of Participants | Participants |
|
|
|
| Secondary | Need for Additional Local Anesthetic | Need for additional infiltrated local anesthetic (lidocaine) | Posted | Count of Participants | Participants | At any time during suturing procedure, time frame is duration of procedure, generally 10-20 minutes, less than one hour. Determined by chart review immediately after procedure completion. |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Triple LET | Three applications of LET topical gel, one applied every 10 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic | 0 | 27 | 0 | 27 | 0 | 27 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004735 | Energy Transfer |
| D055592 | Biophysical Phenomena |
| D055585 | Physical Phenomena |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |