A comparison of midazolam, diazepam, and placebo as oral anesthetic premedicants in younger children.

STUDY OBJECTIVES

To validate the superiority of higher-dose oral midazolam as an anesthetic premedicant in children 6 years of age and younger, to determine whether less expensive diazepam is a viable alternative oral premedicant in this age-group, and to assess the preoperative oxygenation effects of both benzodiazepines.

DESIGN

A prospective, randomized, double-blind study.

SETTING

Outpatient surgery department and operating room (OR) of a freestanding children's hospital.

PATIENTS

Seventy-five ASA physical status I and II outpatients 1 to 6 years of age.

INTERVENTIONS

Patients were randomized to receive either midazolam 0.6 mg/kg, diazepam 0.3 mg/kg, or a placebo orally in a timely manner prior to surgery.

MEASUREMENTS AND MAIN RESULTS

Each child's subsequent reaction to separation from his or her parents in the presurgical holding area was scored on a three-point behavioral scale. Once in the OR, an initial room air oxygen saturation by pulse oximeter (SpO2) was obtained. Each child's initial acceptance of the anesthetic induction mask was then scored on a four-point scale. No significant differences in parental separation scores, initial room air SpO2, or postanesthesia care unit admission time were observed among the three study groups. However, both midazolam and diazepam were observed to be superior to the placebo in facilitating the initial acceptance of the anesthetic induction mask.

CONCLUSIONS

Even without premedication, a majority of children did not react negatively to an impending anesthetic. Therefore, neither midazolam nor diazepam appears to be necessary in most children younger than 6 years of age. Rather than implementing the routine use of an oral preoperative sedative, the challenge appears to be the selective identification of those children at risk for preanesthetic difficulties and psychological trauma.