Skin LacerationsLETNCT04378283
Prospective Evaluation of Topical Anesthesia in Children
A study testing LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) and EMLA plus infiltration as anesthetic for wound repair. in people with Skin Lacerations, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study is designed to assess efficacy and comfort of LET solution vs. EMLA cream and topical infiltration of lidocaine. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Skin Lacerations
- What is being tested?
- LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) and EMLA plus infiltration as anesthetic for wound repair.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to May 2020
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Chronological age above 3 and below 18 years
- Dermal laceration that needs surgical repair
- Signed informed consent by the parent or guardian of the patient
Who cannot join
- Skin laceration of nose tip, fingers, genitalia
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to assess efficacy and comfort of LET solution vs. EMLA cream and topical infiltration of lidocaine.
Read the detailed description
Pain caused by repair of torn skin is usually an unpleasant experience for pediatric patients. Analgesia or pain control is conventionally achieved by local anaesthetic infiltration. Local anaesthetics are a class of drugs that interrupt the transmission of electrical impulses along sensory nerves by inactivating sodium channels (Eidelman et al., 2011). However, the infiltration of local anaesthetics, which involves injecting the medication into the skin, may itself cause significant pain and fear in children (Kundu and Achar, 2002, Boettcher et al., 2012).
Pain management has been increasingly recognized as an element of high quality patient care, yet studies have shown deficiencies in pediatric emergency department (PED) pain management in children (Lawton and Hadj, 2014, Fein et al., 2012). Resolution of pain and perception of pain have been documented as one of the top indicators of patient and parent satisfaction and measure of quality of care in the PED (Magaret et al., 2002). Children are particularly susceptible to pain, even when caused by simple procedures (Boettcher et al., 2012). Well-managed pain has been associated with faster recoveries, fewer complications, and decreased use of health care resources (Zhu et al., 2012).
LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair. LET gel offers many advantages for repair of tissue laceration including epinephrine-induced vasoconstriction, promotion of dry surfaces required for tissue adhesive laceration repair, and reduction of discomfort (MacLean et al., 2007). Topical anesthetics have been shown to improve procedural success rates and reduce procedural times, likely due to decreased patient movement and pain reduction (Taddio et al., 2005). LET has been shown to significantly reduce the need for injecting local anesthetics to the wound site, which is a cause of much anxiety and pain in children (Taddio et al., 2005, Singer and Stark, 2001).
In many PED - as in our department - LET solution and EMLA pretreatment and subsequent lidocaine infiltration are used depending on the personal experience and preference of the physician. The objective of this study is to determine if LET solution is as effective as EMLA and lidocaine infiltration in terms of comfort and effectiveness.
Primary Hypothesis:
LET solution is as effective as EMLA and lidocaine infiltration in controlling pain.
Secondary Hypothesis:
LET solution is superior to EMLA and lidocaine infiltration in terms of comfort.
- Conditions
- Skin Lacerations
- Being tested
- LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%), EMLA plus infiltration as anesthetic for wound repair.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%)Drug
The study is designed to evaluate topical anesthetics
EMLA plus infiltration as anesthetic for wound repair.Drug
EMLA plus infiltration as anesthetic for wound repair.
| Study group | Role | What they receive |
|---|---|---|
| LET as topical anesthetic for wound repair. | Experimental | LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair. Receives: Drug: LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) |
| EMLA plus infiltration as anesthetic for wound repair. | Active comparator | EMLA ("eutectic mixture of local anesthetics") with subsequent lidocaine infiltration. EMLA is a mixture of lidocaine (2.5%) and prilocaine (2.5%) in a cream base. Receives: Drug: EMLA plus infiltration as anesthetic for wound repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during skin repair
Pediatric pain scale
Measured: 2 weeks
Secondary outcomes (2)
Infections during skin repair
Purulent discharge from the surgical site Purulent discharge from wound or drain placed in wound Organisms isolated from aseptically obtained wound culture Must be at least one of the signs and symptoms of infection - pain or tenderness, localised swelling, or redness/heat.
Measured: 2 weeks
Speed during skin repair
Time from start until wound closure
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study startMay 2016
- Primary completionFeb 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LacerationsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Michael Boettcher, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Michael Boettcher, MD PhD, Principal investigator, UKE Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378283
- Sponsor's protocol ID
- UHHamburgEppendorf_LET
- Acronym
- LET
- Status last verified
- May 2020
- First submitted
- 16 May 2016
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Topical Anesthesia in Children
- ClinicalTrials.gov ID
- NCT04378283
- Acronym / sponsor ID
- LET / UHHamburgEppendorf_LET
- Conditions
- Skin Lacerations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 7 May 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.
This study is designed to assess efficacy and comfort of LET solution vs. EMLA cream and topical infiltration of lidocaine.
Detailed description
Pain caused by repair of torn skin is usually an unpleasant experience for pediatric patients. Analgesia or pain control is conventionally achieved by local anaesthetic infiltration. Local anaesthetics are a class of drugs that interrupt the transmission of electrical impulses along sensory nerves by inactivating sodium channels (Eidelman et al., 2011). However, the infiltration of local anaesthetics, which involves injecting the medication into the skin, may itself cause significant pain and fear in children (Kundu and Achar, 2002, Boettcher et al., 2012).
Pain management has been increasingly recognized as an element of high quality patient care, yet studies have shown deficiencies in pediatric emergency department (PED) pain management in children (Lawton and Hadj, 2014, Fein et al., 2012). Resolution of pain and perception of pain have been documented as one of the top indicators of patient and parent satisfaction and measure of quality of care in the PED (Magaret et al., 2002). Children are particularly susceptible to pain, even when caused by simple procedures (Boettcher et al., 2012). Well-managed pain has been associated with faster recoveries, fewer complications, and decreased use of health care resources (Zhu et al., 2012).
LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair. LET gel offers many advantages for repair of tissue laceration including epinephrine-induced vasoconstriction, promotion of dry surfaces required for tissue adhesive laceration repair, and reduction of discomfort (MacLean et al., 2007). Topical anesthetics have been shown to improve procedural success rates and reduce procedural times, likely due to decreased patient movement and pain reduction (Taddio et al., 2005). LET has been shown to significantly reduce the need for injecting local anesthetics to the wound site, which is a cause of much anxiety and pain in children (Taddio et al., 2005, Singer and Stark, 2001).
In many PED - as in our department - LET solution and EMLA pretreatment and subsequent lidocaine infiltration are used depending on the personal experience and preference of the physician. The objective of this study is to determine if LET solution is as effective as EMLA and lidocaine infiltration in terms of comfort and effectiveness.
Primary Hypothesis:
LET solution is as effective as EMLA and lidocaine infiltration in controlling pain.
Secondary Hypothesis:
LET solution is superior to EMLA and lidocaine infiltration in terms of comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LET as topical anesthetic for wound repair. | Experimental | Drug: LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%)LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair. |
| EMLA plus infiltration as anesthetic for wound repair. | Active comparator | Drug: EMLA plus infiltration as anesthetic for wound repair.EMLA ("eutectic mixture of local anesthetics") with subsequent lidocaine infiltration. EMLA is a mixture of lidocaine (2.5%) and prilocaine (2.5%) in a cream base. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Chronological age above 3 and below 18 years
- Dermal laceration that needs surgical repair
- Signed informed consent by the parent or guardian of the patient
Key exclusion criteria (1 listed)
- Skin laceration of nose tip, fingers, genitalia
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 gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%)The study is designed to evaluate topical anesthetics | Drug | LET as topical anesthetic for wound repair. |
| EMLA plus infiltration as anesthetic for wound repair.EMLA plus infiltration as anesthetic for wound repair. | Drug | EMLA plus infiltration as anesthetic for wound repair. |
Primary outcome
Pain during skin repair
Time frame: 2 weeks
Pediatric pain scale
2 secondary outcomes
Infections during skin repair
Time frame: 2 weeks
Speed during skin repair
Time frame: 2 weeks
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 7 May 2020.
- 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.
Michael Boettcher, MD PhD principal investigator
UKE Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) and EMLA plus infiltration as anesthetic for wound repair. in people with Skin Lacerations, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 3 inclusion and 1 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 7 May 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 Germany. 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.
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?
Pain during skin repair (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2020.