Prospective Evaluation of Topical Anesthesia in Children (LET)
Primary Purpose
Skin Lacerations
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%)
EMLA plus infiltration as anesthetic for wound repair.
Sponsored by
About this trial
This is an interventional treatment trial for Skin Lacerations
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
Sites / Locations
- UKE Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LET as topical anesthetic for wound repair.
EMLA plus infiltration as anesthetic for wound repair.
Arm Description
LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration 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.
Outcomes
Primary Outcome Measures
Pain during skin repair
Pediatric pain scale
Secondary Outcome Measures
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.
Speed during skin repair
Time from start until wound closure
Full Information
NCT ID
NCT04378283
First Posted
May 16, 2016
Last Updated
May 6, 2020
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT04378283
Brief Title
Prospective Evaluation of Topical Anesthesia in Children
Acronym
LET
Official Title
Prospective Evaluation of Topical Anesthesia in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Lacerations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LET as topical anesthetic for wound repair.
Arm Type
Experimental
Arm Description
LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%) is a topical anesthetic that is routinely used before laceration repair.
Arm Title
EMLA plus infiltration as anesthetic for wound repair.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%)
Intervention Description
The study is designed to evaluate topical anesthetics
Intervention Type
Drug
Intervention Name(s)
EMLA plus infiltration as anesthetic for wound repair.
Intervention Description
EMLA plus infiltration as anesthetic for wound repair.
Primary Outcome Measure Information:
Title
Pain during skin repair
Description
Pediatric pain scale
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Infections during skin repair
Description
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.
Time Frame
2 weeks
Title
Speed during skin repair
Description
Time from start until wound closure
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Boettcher, MD PhD
Organizational Affiliation
UKE Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UKE Medical School
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Evaluation of Topical Anesthesia in Children
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