LETPhase 4LETNCT04536493
Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair
A Phase 4 study testing LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application) and LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications) in people with LET and Laceration of Skin, run by Children's Hospital of Orange County at 1 site in United States.
Trial summary
To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- LET, Laceration of Skin
- What is being tested?
- LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application) and LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 25 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- • Patients with simple (< 3 cm) lacerations who are > 7 years old and < 18 years old, for whom the physician plans to close the laceration using simple superficial interrupted sutures.
Who cannot join
- • Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints.
- Patients who are developmentally delayed or have a disability preventing them from giving a reliable pain score.
- Patients whose primary language is other than English or Spanish.
- Patients for whom procedural sedation is required.
- Patients receiving intranasal or oral midazolam or inhaled nitrous oxide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair
To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET). Single LET is the current standard method of application.
Read the detailed description
To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET).
Secondary endpoints:
- To compare provider satisfaction scores using a Likert scale between the triple LET and single LET application techniques.
- To compare parental satisfaction scores using a Likert scale between the triple LET and single LET application techniques.
- To compare the need for additional local anesthetic infiltration between the triple LET and single LET application techniques.
Once patients are identified and consent is obtained, they will be randomized to one of two groups. One group will have LET gel applied to the laceration one time for a duration of 30 minutes. The other group will have LET gel applied 3 times, at 10 minute intervals. Between applications, the excess gel on the surface of the skin will be gently wiped off, and a new strip of LET gel will be applied. The laceration repair will proceed in a normal sterile fashion, using standard irrigation and debridement techniques. Laceration repair will occur within the 15 minutes following the 30 minute period of LET application to the wound. The patient will be asked to rate his/her pain immediately after the first suture is placed or attempted using the visual analogue scale (VAS, range 0-10). The decision to use any additional anesthetic infiltration will be left to the performing provider. There will be 2 nurses involved in the study. One nurse will be the patient's primary nurse and will be administering the LET gel (so will not be blinded, but will not be involved in data collection). The other nurse will be obtaining the VAS immediately (Appendix 3) after the first suture is placed, using a pre-prepared script (Appendix 3) and standardized technique. The nurse or research assistant will also be blinded as to the method of LET gel application. The provider performing the laceration repair will be blinded. The research assistant will not be blinded and will coordinate all involved providers and nurses, will ensure correct timing in LET gel administration, and laceration repair timing.
- Conditions
- LET, Laceration of Skin
- Being tested
- LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application), LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application)Drug
Also called LET gel
1 application of LET topical anesthetic gel
LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)Drug
Also called LET gel
3 applications of LET topical anesthetic gel
| Study group | Role | What they receive |
|---|---|---|
| 1 application | Active comparator | Patients receive single dose LET Receives: Drug: LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application) |
| 3 applications | Active comparator | Patients receive 3 doses of LET Receives: Drug: LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare pain scores
Visual Analog Scale (VAS) asks subjects to rate pain marking an X on a line between two ends: "No pain" (on the left) and "Pain as bad as it could possibly be" (on the right). The distance will be measured from "No pain" to the X placed by the subject. A higher measurement indicates more pain.
Measured: The VAS to rate pain will be collected during laceration repair, immediately after the first suture placement or attempt. The VAS score is estimated to take up to 1 minute to collect. The VAS scale will be collected for each enrolled subject.
Secondary outcomes (2)
To compare provider satisfaction scores
Likert scale will be used in 3 questions asking providers to rate their satisfaction, preference for Single LET application, and preference for Triple LET application. For the satisfaction question, the likert scale offers options from Dissatisfied to Extremely Satisfied, as well as Not Applicable. The preference for Single LET is a likert scale with options ranging from Strongly Disagree to Strongly Agree, as well as a Not Applicable. The preference for Triple LET is a likert scale with options ranging from Strongly Disagree to Strongly Agree, as well as a Not Applicable. It will take approximately 3 minutes to administer. This measure will be completed once for each enrollment prior to discharge from the Emergency Department.
Measured: The provider satisfaction Likert scale will be collected immediately after the procedure.
To compare parental satisfaction scores
Parent satisfaction will be measured using a single question as a Likert scale with options from Dissatisfied to Extremely Satisfied, as well as Not Applicable. It will take approximately 1-2 minutes to administer. This measure will be completed once for each enrollment prior to discharge from the Emergency Department.
Measured: The parental satisfaction Likert scale will be collected immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start19 Jun 2019
- Primary completion6 Nov 2019
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LETStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing two different applications of LET gel in pediatric patients with minor lacerations.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodore Heyming, Children's Hospital of Orange County
- Investigators
- Joshua Siembieda, Principal investigator, CHOC Childrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536493
- Sponsor's protocol ID
- 190224
- Acronym
- LET
- Status last verified
- Sep 2020
- First submitted
- 20 Jun 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harman S, Zemek R, Duncan MJ, Ying Y, Petrcich W. Efficacy of pain control with topical lidocaine-epinephrine-tetracaine during laceration repair with tissue adhesive in children: a randomized controlled trial. CMAJ. 2013 Sep 17;185(13):E629-34. doi: 10.1503/cmaj.130269. Epub 2013 Jul 29.
PubMed 23897942Priestley S, Kelly AM, Chow L, Powell C, Williams A. Application of topical local anesthetic at triage reduces treatment time for children with lacerations: a randomized controlled trial. Ann Emerg Med. 2003 Jul;42(1):34-40. doi: 10.1067/mem.2003.207.
PubMed 12827121
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair
- ClinicalTrials.gov ID
- NCT04536493
- Acronym / sponsor ID
- LET / 190224
- Conditions
- LET, Laceration of Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET). Single LET is the current standard method of application.
Detailed description
To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET).
Secondary endpoints:
- To compare provider satisfaction scores using a Likert scale between the triple LET and single LET application techniques.
- To compare parental satisfaction scores using a Likert scale between the triple LET and single LET application techniques.
- To compare the need for additional local anesthetic infiltration between the triple LET and single LET application techniques.
Once patients are identified and consent is obtained, they will be randomized to one of two groups. One group will have LET gel applied to the laceration one time for a duration of 30 minutes. The other group will have LET gel applied 3 times, at 10 minute intervals. Between applications, the excess gel on the surface of the skin will be gently wiped off, and a new strip of LET gel will be applied. The laceration repair will proceed in a normal sterile fashion, using standard irrigation and debridement techniques. Laceration repair will occur within the 15 minutes following the 30 minute period of LET application to the wound. The patient will be asked to rate his/her pain immediately after the first suture is placed or attempted using the visual analogue scale (VAS, range 0-10). The decision to use any additional anesthetic infiltration will be left to the performing provider. There will be 2 nurses involved in the study. One nurse will be the patient's primary nurse and will be administering the LET gel (so will not be blinded, but will not be involved in data collection). The other nurse will be obtaining the VAS immediately (Appendix 3) after the first suture is placed, using a pre-prepared script (Appendix 3) and standardized technique. The nurse or research assistant will also be blinded as to the method of LET gel application. The provider performing the laceration repair will be blinded. The research assistant will not be blinded and will coordinate all involved providers and nurses, will ensure correct timing in LET gel administration, and laceration repair timing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing two different applications of LET gel in pediatric patients with minor lacerations.
| Arm | Type | Receives |
|---|---|---|
| 1 application | Active comparator | Drug: LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application)Patients receive single dose LET |
| 3 applications | Active comparator | Drug: LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)Patients receive 3 doses of LET |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- • Patients with simple (< 3 cm) lacerations who are > 7 years old and < 18 years old, for whom the physician plans to close the laceration using simple superficial interrupted sutures.
Key exclusion criteria (5 listed)
- • Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application)Also: LET gel1 application of LET topical anesthetic gel | Drug | 1 application |
| LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)Also: LET gel3 applications of LET topical anesthetic gel | Drug | 3 applications |
Primary outcome
To compare pain scores
Time frame: The VAS to rate pain will be collected during laceration repair, immediately after the first suture placement or attempt. The VAS score is estimated to take up to 1 minute to collect. The VAS scale will be collected for each enrolled subject.
Visual Analog Scale (VAS) asks subjects to rate pain marking an X on a line between two ends: "No pain" (on the left) and "Pain as bad as it could possibly be" (on the right). The distance will be measured from "No pain" to the X placed by the subject. A higher measurement indicates more pain.
2 secondary outcomes
To compare provider satisfaction scores
Time frame: The provider satisfaction Likert scale will be collected immediately after the procedure.
To compare parental satisfaction scores
Time frame: The parental satisfaction Likert scale will be collected immediately after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Background: PubMed 23897942Harman S, Zemek R, Duncan MJ, Ying Y, Petrcich W. Efficacy of pain control with topical lidocaine-epinephrine-tetracaine during laceration repair with tissue adhesive in children: a randomized controlled trial. CMAJ. 2013 Sep 17;185(13):E629-34. doi: 10.1503/cmaj.130269. Epub 2013 Jul 29.
- Background: PubMed 12827121Priestley S, Kelly AM, Chow L, Powell C, Williams A. Application of topical local anesthetic at triage reduces treatment time for children with lacerations: a randomized controlled trial. Ann Emerg Med. 2003 Jul;42(1):34-40. doi: 10.1067/mem.2003.207.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Siembieda principal investigator
CHOC Childrens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application) and LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications) in people with LET and Laceration of Skin, run by Children's Hospital of Orange County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare pain scores (time frame: The VAS to rate pain will be collected during laceration repair, immediately after the first suture placement or attempt. The VAS score is estimated to take up to 1 minute to collect. The VAS scale will be collected for each enrolled subject.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536493, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.