Objective: To compare the effectiveness of prilocaine-phenylephrine (Prilophen), a new topical anesthetic that does not contain cocaine, to that of lidocaine infiltration during repair of lacerations on or near mucous membranes in children.
Design: A prospective, randomized, blinded trial.
Setting: The emergency department of a large academic children's hospital.
Patients: Children one year of age or older with a laceration 5 cm or less in length on or near a mucous membrane.
Interventions: Forty patients were randomly assigned one of the two local anesthetics, with 20 patients in each treatment group.
Outcome measures: Pain felt during suturing was scored by suture technicians, research assistants, a videotape reviewer, parents, and patients five years of age and older using a visual analog scale (VAS).
Results: There was no statistically significant difference in performance between topical Prilophen and lidocaine infiltration when VAS pain scores of research assistants, parents, and patients were compared. However, lidocaine infiltration performed significantly better than topical Prilophen when comparing VAS scores of suture technicians (P = 0.003) and the videotape reviewer (P = 0.02). When power analyses were performed using alpha = 0.05 and beta = 0.20, it was possible to detect a difference of 2 units for VAS scores of suture technicians, 2 VAS units for research assistants, 3 VAS units for the videotape reviewer and parents, and 7 VAS units for patients. There were no wound healing or other complications.
Conclusions: Prilophen is a new topical anesthetic alternative to lidocaine infiltration for closure of lacerations on or near mucous membranes, where use of tetracaine-adrenaline-cocaine is contraindicated. The performance of Prilophen was rated by two of the observer groups as statistically inferior to that of lidocaine infiltration; however, the differences in pain scores were small and may not be clinically significant. Further investigation of this new topical anesthetic is warranted.