Prospective Evaluation of Topical Anesthesia in Children

NCT ID: NCT04378283

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-05-31

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.

Conditions

Skin Lacerations

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

The study is designed to evaluate topical anesthetics

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.

Group Type: ACTIVE_COMPARATOR

EMLA plus infiltration as anesthetic for wound repair.

Intervention Type: DRUG

EMLA plus infiltration as anesthetic for wound repair.

Interventions

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

The study is designed to evaluate topical anesthetics

Intervention Type: DRUG

EMLA plus infiltration as anesthetic for wound repair.

EMLA plus infiltration as anesthetic for wound repair.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Michael Boettcher

PD Dr. Michael Boettcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Boettcher, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UKE Medical School

Locations

UKE Medical School

Hamburg, , Germany

Countries

Germany

Other Identifiers

UHHamburgEppendorf_LET

Identifier Type: -

Identifier Source: org_study_id