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Randomized Controlled Trial Comparative Study Clinical Trial
New non-cocaine-containing topical anesthetics compared with tetracaine-adrenaline-cocaine during repair of lacerations.
- G A Smith, S D Strausbaugh, C Harbeck-Weber, D M Cohen, B J Shields, and J D Powers.
- Division of Emergency Medicine, Children's Hospital, Columbus, Ohio 43205, USA.
- Pediatrics. 1997 Nov 1;100(5):825-30.
ObjectiveTo compare the effectiveness of three new topical anesthetics that do not contain cocaine (prilocaine-phenylephrine, tetracaine-phenylephrine [tetraphen], and tetracaine-lidocaine-phenylephrine) to that of tetracaine-adrenaline-cocaine (TAC) during laceration repair in children.DesignProspective, randomized, double-blind clinical trial.SettingThe emergency department of an urban children's hospital.ParticipantsChildren 1 year of age or older with a laceration = 5 cm in length that required suturing. Intervention. A total of 240 children were randomly assigned to one of four treatment groups.Outcome MeasuresPain felt during suturing was scored by suture technicians, research assistants, parents, and patients >/= 5 years of age using a visual analogue scale (VAS). Suture technicians, research assistants, and parents also scored pain using a seven-point Likert scale. In addition, suture technicians completed an anesthetic effectiveness scale.ResultsThere was consistently no difference demonstrated between the effectiveness of tetraphen and that of TAC for each outcome measure of each observer group. A statistically significant difference was seen among anesthetics when comparing VAS and Likert scale scores of suture technicians and Likert scale scores of research assistants. Based on post hoc analyses, these statistically significant differences were between TAC and prilocaine-phenylephrine (suture technician VAS and Likert scale) and between TAC and tetracaine-lidocaine-phenyl-ephrine (suture technician Likert scale), but not between TAC and tetraphen. When power analyses were performed using alpha = 0.05 and beta = 0.20, it was possible to detect a difference of 1.2 VAS units for each of the observer groups. Based on anesthetic effectiveness scale scores, the three new topical preparations collectively performed significantly better on the face and scalp than on the extremities (relative risk = 1.83; 95% confidence interval 1.20 < relative risk < 2.79).ConclusionThis study demonstrated the effectiveness and safety of three new non-cocaine-containing topical anesthetics. Consistently, there was no statistical difference demonstrated between the effectiveness of tetraphen and that of TAC for each outcome measure of each observer group. Tetraphen offers an effective alternative to TAC during laceration repair in children.
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