Objective: The aim of this study was to compare the anesthetic efficacy of prilocaine infiltration and a eutectic mixture of local anesthetics (EMLA) in cream for femoral vessel catheterization during pediatric cardiac catheterization and to evaluate whether EMLA cream application improves cannulation success.
Design: Prospective, randomized clinical trial.
Setting: A university hospital.
Participants: Forty American Society of Anesthesiologists class III and IV children scheduled for cardiac catheterization via the femoral route were included.
Interventions: The children were randomly assigned to 2 groups. The EMLA group (n = 20) had EMLA cream applied to the groin 60 minutes before the procedure, and the control group (n = 20) had prilocaine infiltrated at the site 5 minutes before the procedure. Boluses of intravenous midazolam, 0.1 mg/kg, and/or ketamine, 1 mg/kg, were given to achieve and maintain a predetermined sedation score of 2-3 (0 = deeply sedated, 5 = agitated) throughout the procedure (sedation monitored every 5 minutes). The groups were compared with respect to demographic data, hemodynamic and respiratory parameters/complications, amounts of additional sedative-analgesics required, cannulation time, and cannulation results (first-attempt success [right groin], second-attempt success [left groin], or failure on both attempts). Each group's "overall cannulation success rate" was calculated as the proportion of cases in which cannulation was achieved on the first or second attempt.
Measurements and main results: The demographic data and the group findings for hemodynamic and respiratory parameters/complications, additional amounts of sedative-analgesics needed, cannulation times, and overall cannulation success rate were similar. The mean sedation score during femoral puncture in the EMLA group was significantly lower than that in the control group (3 +/- 1 v 4 +/- 1, respectively, p = 0.001). There were no other significant differences between the groups with respect to sedation scores during the procedure. The respective frequencies of first-attempt cannulation success in the EMLA and control groups were 75% and 45% (p = 0.05).
Conclusion: The study showed that EMLA cream provides adequate topical anesthesia for femoral vessel cannulation during pediatric cardiac catheterization and may also increase the likelihood of cannulation success. However, use of this cream has no effect on sedative-analgesic requirements or on the risks of hemodynamic and respiratory complications during this procedure.