Prospective Evaluation of Topical Anesthesia in Children

Study Overview
=================
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.

Official Title
-----------------
Prospective Evaluation of Topical Anesthesia in Children

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.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Skin laceration of nose tip, fingers, genitalia

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LET as topical anesthetic for wound repair.<br>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%)<br>* The study is designed to evaluate topical anesthetics<br>|
| Active Comparator: EMLA plus infiltration as anesthetic for wound repair.<br>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.<br>* EMLA plus infiltration as anesthetic for wound repair.<br>|

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 |