A randomized controlled trial comparing: a) a combination of oral chlo
ral hydrate and promethazine to b) a continuous intravenous midazolam
infusion, for maintenance sedation in critically ill children, was car
ried out. The level of sedation was assessed four hourly using a speci
fically devized sedation scale. Forty-four children entered the study
of whom two were subsequently excluded. The number of satisfactory ass
essments (desired and actual levels of sedation equal) was significant
ly greater in the chloral hydrate and promethazine group (Chi-squared
P<0.01; confidence intervals of the difference 0.06 to 0.20). The numb
er of assessments at level 5 on the sedation scale (patient restless/d
istressed) was significantly greater in the midazolam group (Chi-squar
ed P<0.05). The total number of satisfactory assessments in the two gr
oups were only 61 and 48% respectively, suggesting that sedation can b
e considerably improved. Chloral hydrate and promethazine are more eff
ective than midazolam as maintenance sedation in critically ill childr
en. It is possible to prospectively study the efficacy of sedative dru
gs in critically ill children.