The advantages of the addition of low-dose sufentanil to local anaesth
etics in epidural analgesia during labour (improvement of analgesia, r
eduction of total dose of local anaesthetic, reduction of rate of inst
rumental delivery outweigh) far the disadvantages (pruritus, sedation,
potential maternal and neonatal respiratory depression). In over 8000
cases, the addition of incremental sufentanil (7.5 mug) up to 30 mug
has not caused any negative effects on newborns, and hence, the additi
on of sufentanil is justified; it may even be indicated. Sufentanil ha
s not yet been registered for epidural analgesia in Germany, in contra
st to other countries. In considering whether this fact may prohibit i
ts use, two aspects should be discussed: therapy and clinical experime
nts. The difference lies in the purpose rather than in the method of a
dministration. Ethical and legal requirements for clinical tests are a
nchored in the declaration of Helsinki and the code of the medical pro
fession. The legal background for therapy is represented in the provis
o of the German Civil and Criminal Codes as well as the code of conduc
t on professional liability of the physician. Pain during labour is no
absolute indication for the addition of sufentanil, but there are con
siderable arguments for its superiority in comparison to other standar
d procedures: the side effects and complications are very limited. Jus
tification of this method is relatively easy in view of the fact that
sufentanil has already been registered for peridural analgesia in obst
etrics in many other countries. Last but not least, the patient must g
ive informed consent before any procedure can be performed.