Prospective Evaluation of Topical Anesthesia in Children (LET)

This study is designed to assess efficacy and comfort of LET solution vs. EMLA cream and topical infiltration of lidocaine.

Study Overview

• Status: Completed
• Conditions: Skin Lacerations
• Intervention / Treatment: Drug: LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%); Drug: EMLA plus infiltration as anesthetic for wound repair.

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • UKE Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LET as topical anesthetic for wound repair.; LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair.	Drug: LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%); The study is designed to evaluate topical anesthetics
Active Comparator: 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.	Drug: EMLA plus infiltration as anesthetic for wound repair.; EMLA plus infiltration as anesthetic for wound repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during skin repair	Pediatric pain scale	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks
Speed during skin repair	Time from start until wound closure	2 weeks

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Michael Boettcher, MD PhD, UKE Medical School

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Anesthetics; Lidocaine; Epinephrine; Tetracaine
• Other Study ID Numbers: UHHamburgEppendorf_LET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No