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Prospective Evaluation of Topical Anesthesia in Children

Prospective Evaluation of Topical Anesthesia in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04378283
Acronym
LET
Enrollment
99
Registered
2020-05-07
Start date
2016-05-31
Completion date
2020-05-31
Last updated
2020-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Lacerations

Brief summary

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.

Interventions

DRUGLET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%)

The study is designed to evaluate topical anesthetics

DRUGEMLA plus infiltration as anesthetic for wound repair.

EMLA plus infiltration as anesthetic for wound repair.

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Chronological age above 3 and below 18 years 2. Dermal laceration that needs surgical repair 3. Signed informed consent by the parent or guardian of the patient

Exclusion criteria

* Skin laceration of nose tip, fingers, genitalia

Design outcomes

Primary

MeasureTime frameDescription
Pain during skin repair2 weeksPediatric pain scale

Secondary

MeasureTime frameDescription
Infections during skin repair2 weeksPurulent 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.
Speed during skin repair2 weeksTime from start until wound closure

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026