Prospective Evaluation of Topical Anesthesia in Children
Condition: Skin Lacerations
MeSH terms: Lacerations
Study type: Interventional

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.
    

Intervention name(s): LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%); EMLA plus infiltration as anesthetic for wound repair.
Intervention type(s): Drug; Drug
Intervention description(s): The study is designed to evaluate topical anesthetics; EMLA plus infiltration as anesthetic for wound repair.
Intervention MeSH terms: Lidocaine; Epinephrine; Tetracaine; Anesthetics
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment