Results obtained with piracetam in foetal distress during labour. Inefficacy of piracetam in the prevention of painful crises in children and adolescents with sickle cell disease. A comparative study of the safety of 0.25% levobupivacaine and 0.25% racemic bupivacaine for paracervical block in the first stage of labor. On the efficacy of piracetam in geriatric patients with acute cerebral ischemia: a clinically controlled double-blind study. The influence of betamethasone and orciprenaline on the incidence of respiratory distress syndrome in the newborn after preterm labour. [The effectiveness of piracetam in acute cerebral ischemia in the human. A clinical controlled double-blind study of piracetam/10% dextran 40 versus 10% dextran 40/placebo]. Betamimetics in fetal distress: randomised controlled trial. Intravenous fentanyl PCA during labour. Piracetam in elderly psychiatric patients with mild diffuse cerebral impairment.
A double-blind study was performed on ninety-six parturients of the Lima Maternity Hospital, Peru, with some evidence of foetal distress who were given indistinguishably piracetam or a placebo at random in order to investigate the effects of the drug on the foetus. The conditions of the new-born babies who had received piracetam were superior to those of the babies treated with the placebo, as evaluated with the Apgar at 1, 5 and 10 minutes after birth and on the basis of the neurological and clinical examination as from 24 hours until they were released. In addition, the reduction of the duration of the labour in the patients treated with piracetam as compared with the control group was obvious. Analgesia and hydration remain the only safe treatment for painful crises of sickle cell disease; hydroxyurea is effective, but the toxicity is still a problem. Piracetam is a nootropic drug that has reportedly been effective and non-toxic in sickle cell patients, but most studies were not placebo-controlled and included a small number of patients. The present study evaluated the drug in a double-blind crossed placebo-controlled clinical trial in 73 children and adolescents suffering from moderate to severe painful crises for 13 months. Information regarding frequency and severity of pain was acquired through monthly clinical evaluation, visits and house calls, and 4,300 weekly questionnaires filled out by the patients in their domiciles. A monthly pain score was calculated for each patient. Pain was the most frequent adverse manifestation of the disease stressing its significant bio-psycho-social impact. Although nearly all patients and relatives reported a better clinical course throughout the whole study, the drug was ineffective in the prevention of painful crises. This placebo effect may be ascribed to an unplanned and unsystematic 'cognitive-behavioural' management of the children. The pain score in the second semester of the study - both in the experimental and in the control groups - was significantly smaller than that in the first semester. In conclusion, piracetam was found to be ineffective in the prevention of painful crises; a powerful placebo effect due to adequate patient care was demonstrated.
                Copyright (c) 2005 S. Karger AG, Basel The objective of the study was to evaluate and compare the safety of levobupivacaine and racemic bupivacaine for paracervical block (PCB) in the first stage of labor after uncomplicated pregnancy.
                Forty women in an open pilot study and 397 women in a double-blind randomized study received PCB for pain relief in the first stage of labor, either with 25 mg of levobupivacaine or with 25 mg of racemic bupivacaine. The incidence of cardiotocographic pathology was compared between the groups using Fisher's exact test. The 95% confidence intervals for the between-group difference were calculated by Newcombe's method.
                In the randomized double-blind study, the incidence of any pathological result in cardiotocography (CTG) was 10.4% in the levobupivacaine group and 12.8% in the racemic bupivacaine group. The incidence of fetal bradycardia in the groups was 2.6 and 3.8%, respectively. All the cardiotocographic changes were transient, and no operative intervention was indicated because of CTG. No difference in the analgesic effect between the drugs was found. Most of the parturients in the levobupivacaine group (97%) and in the racemic bupivacaine group (96%) had spontaneous vaginal delivery. Neonatal outcome was good in both groups.
                No difference in cardiotocographic pathology was found between PCB with levobupivacaine compared with PCB with racemic bupivacaine. The incidence of bradycardia was low. PCB was found to be a safe pain-relief method for low-risk parturients. Using a randomized, double blind group comparison, the efficacy and tolerance of piracetam as an additional therapy of hydroxyethyl starch, venous infusion and low dose heparin treatment, which are the basis of therapy in our hospital, has been studied in patients displaying acute cerebral ischemia. A total of 56 patients were enrolled, of whom 27 were given piracetam and 29 served as a control during a 28-day period. Using single photon emission computer tomography (SPECT) analysis, we observed that in 23 piracetam-treated patients (85.2%) a reduction in the area of brain regions displaying an impaired flow rate occurred (P < 0.001; Fisher's exact two-sided test). Only six of placebo-treated patients (20.7%) showed an improved flow rate. Analysis of the recorded computer tomography map gave an improvement coefficient >2 (flow rate marginally or better improved) for 23 piracetam patients as compared with 5 placebo patients (P < 0.001, Uleman test). In a randomized double-blind trial on antenatal corticosteroid treatment for the prevention of respiratory distress syndrome (RDS) a corticosteroid related beneficial effect was found. Possibly of more significance was the finding that the children born within 12 hours of their mother's admission to hospital showed a higher incidence of RDS than those born between 12 hours and one week after admission even in the placebo and untreated groups. Bèta-adrenergic drugs seemed to exert no other influence on the occurrence of RDS than can be explained by the delay of delivery. Prolonged ruptured membranes appeared to decrease the incidence of RDS to the same extent as other symptoms of threatened preterm labour. nan The objective of the study was to investigate if a single dose of Hexoprenaline administered to patients diagnosed as having fetal distress improves neonatal outcome and whether there are any side effects and complications related to hexoprenaline injection. Patients with fetal distress diagnosed by electronic fetal heart rate monitoring with a gestational age of 35 weeks or more in active labor were eligible. Once the decision to deliver the patient by Cesarean section was made, patients were approached and randomised by sealed opaque envelopes to hexoprenaline or control groups. Ten micrograms of hexoprenaline were administered intravenously to study patients. Main outcomes were cord blood gas values, Apgar scores, the need for resuscitation and admission to intensive care. There were no statistically significant differences in the main outcome measures between the two groups. Fewer babies in the hexoprenaline group had a pH of < 7.2 and a base excess of < -10, but this was not statistically significant. The fetal heart rate pattern was improved in significantly more patients after hexoprenaline administration than controls. In conclusion, despite the statistically significant improvement in fetal heart rate tracings, Apgar scores and blood gas values showed only a trend towards improvement in the hexoprenaline group. To evaluate the usefulness of intravenous patient-controlled analgesia (PCA) fentanyl for labour analgesia, its effectiveness for maternal pain and safety for the fetus and newborn.
                Twenty primigravidas were randomised to receive intravenous PCA fentanyl or epidural analgesia for labour pain. Maternal pain, heart rate and arterial oxyhaemoglobin saturation (SpO2) were monitored. Fetal and neonatal monitoring included cardiotocogram (CTG), APGAR, neurological scoring and static-charge-sensitive bed (SCSB) recording for 12 hr postnatally with ECG and SpO2. Fentanyl concentrations and pH of umbilical artery and vein were analysed.
                Initially, epidural analgesia was more effective (P = 0.01), and three patients in the fentanyl group were given epidural due to unsatisfactory pain relief. Overall satisfaction for analgesia did not differ between the groups. Maternal side-effects were more frequent in the fentanyl group (dizziness and tiredness most often, P = 0.0001). Severe side-effects were not reported. In CTG there were no differences between groups. All the newborns were healthy, APGAR and pH were normal. Naloxone was not used. Neurological scoring was similar in both groups. In 12 hr monitoring heart rate, breathing frequency and movement time were similar in both groups, but SpO2 was lower in the fentanyl group (P < 0.001). Umbilical cord fentanyl concentrations were low or beyond the detection limit.
                Intravenous fentanyl can be used for labour analgesia with the doses reported here as an alternative to epidural analgesia. However, the fetus and neonate must be appropriately monitored. Naloxone and oxygen should be available if neonatal distress occurs. In a 12-week double-blind study, piracetam at two dose levels (2.4 and 4.8 g/day) was compared to placebo in the treatment of 60 elderly psychiatric patients with mild diffuse cerebral impairment, but no signs of focal brain lesion. The psychiatric illness, schizophrenia or affective disorder, of patients selected was in remission at the time of the study. Monthly evaluations by the nurse revealed that piracetam improved overall functioning, particularly alertness, socialization, and cooperation, relative to the control group. Patients treated with 2.4 g/day piracetam also showed significant improvement in scores for the full IQ and the memory quotient on the Wechsler Adult Intelligence and Memory Scales; greater response was seen in those with lower initial scores. Piracetam at 4.8 g/day had a more rapid onset of action on behavioral variables than 2.4 g/day, but its therapeutic effect tended to diminish at 12 weeks, possibly as the result of overstimulation. Piracetam did not appear to interfere with concomitant psychotropic maintenance medication or affect the psychiatric illness itself.
There is not enough evidence to evaluate the use of piracetam for fetal distress in labour.