Intravenous induction of general anaesthesia with eltanolone in children 6-15 years of age.

BACKGROUND

Eltanolone is a short-acting intravenous anaesthetic, formulated as an oil-water emulsion. The aim of the present study was to estimate the anaesthetic dose (ED50) for induction in children 6-10 and 11-15 years of age and to collect safety data.

METHODS

Forty-nine unpremedicated children, all ASA I or II, divided in one pilot-study group, with 5 children 6-15 years and two main study groups, 6-10 and 11-15 years of age, were studied. The first patient in each study group was given 0.86 mg/kg of eltanolone iv over 20 s. Fifty s after injection the chin was gently lifted to "the sniffing position' and the anaesthesia mask was placed over the face. Induction was considered satisfactory if there was no gross movement, coughing or response to verbal command during the following 15 s. The dose selected for the next patient was based on the observed response: if induction was not classified as satisfactory the dose was increased by a factor of 20%, otherwise it was decreased by the same factor. ED50 was estimated as described by Dixon and Massey.

RESULTS

In children 6-10 years of age ED50 was 0.68 (0.49-0.92; 95% confidence limits) mg/kg and in children 11-15 years of age 0.53 (0.41-0.68) mg/kg. No child showed sign of pain on injection. One patient developed urticaria and 15 patients had transient rash after induction. Two patients (both responders receiving 0.86 and 0.40 mg/kg respectively) had apnoea lasting more than 15 s. Involuntary movements occurred in one patient.

CONCLUSION

The ED50 of eltanolone for induction of anaesthesia in unpremedicated children 6-10 years of age was 0.68 mg/kg and in children 11-15 years of age 0.53 mg/kg. The findings suggest that an induction dose for children 6-15 years of age of about 1 mg/kg would be adequate in most cases. No serious adverse events were recorded. However, the drug has subsequently been withdrawn from further investigation due to an unacceptable incidence of rash and urticaria.