Background

Lacerations are a common cause of visits to the pediatric emergency department. Laceration repair can be a traumatizing experience. The use of topical anesthetics may obviate the need for infiltrative anesthetics. This could result in less patient pain, may improve the rate of successful laceration repair and decrease the need for procedural sedation.

Clinical Question

In children ages 3-16 years, is topical LET (Lidocaine-Epinephrine-Tetracaine) superior to topical EMLA (Eutectic Mixture of Local Anesthetics) plus local infiltration of Mepivacaine for pain control after anesthetic application and during laceration repair?

Design

Prospective, cohort study (propensity score-matched)

POPULATION

Inclusion: 3-16 years, dermal laceration needing suturing

Exclusion:

  • Lacerations occurring > 24 hours
  • Lacerations of the digits, nose, ears, penis and bite wounds
  • Chronic diseases, pregnancy, allergy to study medications

Setting:

  • Two pediatric centers in Germany, enrollment period not specified

INTERVENTION

  • LET Gel: Lidocaine (4%)-Epinephrine (0.05%)-Tetracaine (0.5%), (max 5 ml)
  • Applied with a syringe and a sterile dry gauze, Left for 20-30 minutes prior to skin repair

CONTROL

  • EMLA Cream: Eutectic Mixture of Local Anesthetics: Lidocaine (2.5%), Prilocaine
  • (2.5%), (max 5 ml)
  • Applied with a syringe and a sterile dry gauze, Left on for 20-30 min prior to skin repair
  • AND Mepivacaine (1%) Injected using a 30-gauge needle

OUTCOMES

  • Primary Outcome:
    • Pain Reduction: After analgesia and during procedure by patient, parent and provider
  • Secondary Outcomes: Procedure
    • Supplemental infiltration of additional infiltrative anesthetic
  • Secondary Outcomes: At follow-up in 2 weeks (Visit or by phone)
    • Rates of wound infection
    • Overall satisfaction

Primary Results

Primary Outcome

  • Pain Intensity After Study Medication Application
    • Significantly less pain for LET group by patients, parents, and practitioner
    • Patients report significantly more pain than parents or practitioners
  • Pain Intensity During Laceration Repair
    • No difference between LET and EMLA groups for pain scores during treatment
SECONDARY OUTCOMES
MORE ANESTHETIC LET EMLA+MEP P Value
Additional Mepivacaine Given 5/37 (13.5%) 1/22 (4.5%) 0.28
WOUND INFECTION LET EMLA+MEP P Value
Signs of Infection 3/37 (8.1%) 1/22 (4.5%) 0.99
Received Antibiotics 1/37 (2.7%) 0/22 (0.0%) 0.51
SATISFACTION LET EMLA+MEPI P Value
Parent: Immediate After 1.51 [0.55] 1.69 [0.59] 0.62
Parent: At Follow up 1.51 [0.55] 1.69 [0.59] 0.62
Patient: Immediate After 1.59 [0.60] 2.04 [0.90] 0.02
A lower score indicates more satisfaction. *Patients satisfaction at follow not assessed
GREEN = Statistically Significant, RED = Not Statistically Significant

Strengths

  • Propensity score matching to compensate for lack of randomization
  • Propensity scoring resulted in groups equivalent in prognostic factors

Limitations

  • Lack of blinding
  • 18% of LET group received additional Lidocaine. Would have been helpful to present an intention-to-treat and per-protocol analysis
  • Described both as a “random allocation” and “not a randomized clinical trial”
  • Unusual control of topic anesthetic AND infiltrated anesthetic
  • Proportion of patients available only for phone follow up not provided
  • Effect size and required sample size not provided.
  • EMLA application may be insufficient to reach peak analgesia (median 29 minutes, minimum 15 minutes. FDA recommends 1 hour
  • Small sample size: LET: n=37, EMLA+Mepivicaine: n=22 (14 excluded due propensity score matching)
  • Primary outcome only provided in graph form (Figure). Unable to determine absolute risk of risk differences with 95% confidence intervals
  • Secondary outcomes of procedure time and time until pain recurs described in the methods section but results not reported.

Author's Conclusions

“In conclusion, it appears that LET is superior to conventional anesthesia including Mepivacaine injection in the pediatric ED. Pretreatment with LET is significantly less painful but equally effective. Hence, we recommend LET as a topical anesthetic in the pediatric ED.”

Our Conclusions

This study supports our current practice of topical LET with an occlusive dressing with additional infiltration of Lidocaine only as needed. Importantly, patients recorder higher levels than parents and providers.

Read More

PEMCAR – LET vs EMLA and Mepivicaine for Pediatric Laceration Repair – European J Ped Surg 2019

Link: PEMCAR iBook (Apple version)

Link: PEMCAR iBook (PDF)