Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04378283 |
| Other study ID # |
UHHamburgEppendorf_LET |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2016 |
| Est. completion date |
May 2020 |
Study information
| Verified date |
May 2020 |
| Source |
Universitätsklinikum Hamburg-Eppendorf |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is designed to assess efficacy and comfort of LET solution vs. EMLA cream and
topical infiltration of lidocaine.
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.
