Lacerations, LET, Pain, Procedural
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel
Topical anesthetic
Sponsors
Children's Hospital of Orange County
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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)
Intervention model description
Single-blinded randomized study; patients are randomized to one of two groups
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Simple \<= 3cm lacerations requiring suturing (as decided by clinician care providers) * Plan to suture with simple interrupted sutures
Exclusion criteria
* Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints * Patients whose primary language was neither English nor Spanish * Developmentally delayed or disabled patient such that they were unable to give a pain score * Patients requiring procedural sedation or anxiolysis with oral or intranasal midazolam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Pain Score | Immediately on placement or attempt at placement of first suture | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Additional Local Anesthetic | 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. | Need for additional infiltrated local anesthetic (lidocaine) |
Countries
United States
Participant flow
Recruitment details
Convenience sample, pediatric emergency departments at Harbor-UCLA Medical Center and Children's Hospital of Orange County
Participants by arm
| Arm | Count |
|---|---|
| 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 | 21 |
| 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 | 27 |
| Total | 48 |
Baseline characteristics
| Characteristic | Single LET | Triple LET | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 27 Participants | 48 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.7 years STANDARD_DEVIATION 3.1 | 10.3 years STANDARD_DEVIATION 2.6 | 10.5 years STANDARD_DEVIATION 2.8 |
| Laceration location Arm | 0 Participants | 2 Participants | 2 Participants |
| Laceration location Face/Scalp | 18 Participants | 20 Participants | 38 Participants |
| Laceration location Leg | 3 Participants | 5 Participants | 8 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian / Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 14 Participants | 22 Participants | 36 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 2 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 21 participants | 27 participants | 48 participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 16 Participants | 23 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 27 |
| other Total, other adverse events | 0 / 21 | 0 / 27 |
| serious Total, serious adverse events | 0 / 21 | 0 / 27 |
Outcome results
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)
Time frame: Immediately on placement or attempt at placement of first suture
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single LET | Visual Analog Scale Pain Score | 16 mm | Standard Deviation 17 |
| Triple LET | Visual Analog Scale Pain Score | 16 mm | Standard Deviation 24 |
Secondary
Need for Additional Local Anesthetic
Need for additional infiltrated local anesthetic (lidocaine)
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single LET | Need for Additional Local Anesthetic | 4 Participants |
| Triple LET | Need for Additional Local Anesthetic | 5 Participants |