AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Germany1 site
  • UKE Medical School

    Hamburg

Other trials in Germany

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.

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 groups in NCT04378283
Study groupRoleWhat they receive
LET as topical anesthetic for wound repair.ExperimentalLET 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 comparatorEMLA ("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.

  1. Pain during skin repair

    Pediatric pain scale

    Measured: 2 weeks

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted7 May 2020
  2. Study startMay 2016
  3. Primary completionFeb 2020
  4. Study completionMay 2020

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in