A randomized, controlled trial of oral midazolam and buffered lidocaine for suturing lacerations in children (the SLIC Trial).

STUDY OBJECTIVE

To evaluate the efficacy of oral midazolam (0.3 mg/kg) and buffered lidocaine in reducing the anxiety associated with the repair of childhood lacerations.

DESIGN

Prospective, randomized, double-blind, placebo-controlled trial.

SETTING

Community-based emergency department.

PARTICIPANTS

Children younger than 10 years.

INTERVENTIONS

Each subject was randomized into one of four treatment groups: A, midazolam and buffered lidocaine (n = 25); B, placebo and buffered lidocaine (n = 27); C, midazolam and plain lidocaine (n = 32); and D, placebo and plain lidocaine (n = 23).

RESULTS

Anxiety level was scored on a scale of 1 to 4 on the basis of predetermined behavior criteria before and during repair. Parents independently rated the child's distress using a visual analog scale. Vital signs were measured on admission and at discharge. There were no significant differences among the treatment groups for age, location and length of laceration, or initial anxiety scores. Midazolam decreased the number of children with anxiety levels 3 and 4 by 24% (95% CI, 7.5% to 41.3%). There was a 33% reduction of the parents' distress rating with midazolam (P < .01). Buffered lidocaine had no effect on anxiety level.

CONCLUSION

Oral midazolam (0.3 mg/kg) is a safe and effective treatment for reducing anxiety during the suturing of lacerations in children less than 10 years of age. In this study, buffered lidocaine had no effect on anxiety level.