[Nalbuphine and piritramid in the postoperative phase in young children. 1. General condition].

The influence of piritramide and nalbuphine versus placebo on the postoperative comfort of 54 children of ASA-group I and II in the age between 1 and 4 years was tested in a randomized double blind trial using the comfort/discomfort scale according to Büttner et al. METHODS. Operations, premedication and anesthesia were standardized. The patients were premedicated with midazolam 0.5 mg/kg rectally and a subsequent i.m. injection of ketamine 2.0 mg/kg with atropine 0.01 mg/kg. Anesthesia was induced and maintained by inhalation of oxygen/nitrous oxide and halothane (FiO2 = 0.3). All children were intubated and ventilation was controlled during the operation. After the operation, while in steady-state anesthesia with 0.5 vol% halothane and during spontaneous respiration the children received either piritramide (n = 17) or nalbuphine (n = 20) at a dose of 0.1 mg/kg, or placebo (n = 17) i.v. Respiratory and circulatory parameters were recorded for 15 min before the end of anesthesia. At 5 min after halothane had been discontinued the first measurement of the children's behavior was started, with 4 subsequent measurements at fixed time intervals of 15 min. The measuring system included the following 6 scaled items: wake-up reaction, methodical defense against stimuli, crying, facial expression, posture of the torso, posture of the legs. In addition, the waking state was scored at the same time intervals as awake, arousable, or not arousable. During the 1-h observation period all children who seemed to feel uncomfortable received midazolam i.v. at a maximal dose of 2 mg. Up to 24 h the required supplemental analgesics were noted, as were episodes of psychomotor agitation and vomiting. Written consent was obtained from the ethical committee and the children's parents. The results were tested in a 2-factorial analysis of variance (treatment factor: drugs; within-subject factor; repeated measurements). RESULTS. The 3 groups were considered to be comparable in terms of age, body weight, kind and duration of operation and circulatory values. The use of supplementary analgesics showed a significant effect in the treatment factor and in the within-subject factor: during the 1-h observation period the placebo group received midazolam significantly more often (64.7%) than the piritramide group (5.9%) or the nalbuphine group (35%). During the following 7 h 29.4% of the children of the placebo group required supplementary analgesics (piritramide: 23.5%; nalbuphine: 20%). Subsequently up to the 24th postoperative hour there was no need for any analgesic in the placebo group, whereas 11.8% of the piritramide group and 15% of the nalbuphine group required analgesics.(ABSTRACT TRUNCATED AT 400 WORDS)