Intranasal sumatriptan for the acute treatment of migraine. International Intranasal Sumatriptan Study Group.

Two double-blind, placebo-controlled, randomised, multicentre, multinational, parallel-group studies were carried out to identify the optimum dose of intranasal sumatriptan for the acute treatment of migraine. Study medication was taken as a single dose through one nostril in the first study, and as a divided dose through two nostrils in the second study. Totals of 245 and 210 patients with a history of migraine were recruited into the one- and two-nostril studies, respectively. In both studies, headache severity had significantly improved at 120 min after doses of 10-40 mg sumatriptan compared to placebo (P < 0.05) and the greatest efficacy rates were obtained with 20 mg sumatriptan. With 20 mg sumatriptan 78% and 74% of patients experienced headache relief in one- and two-nostril studies respectively. Sumatriptan was generally well tolerated, the most frequently reported event being taste disturbance. The results of the two studies are similar and indicate that administering sumatriptan as a divided dose via two nostrils confers no significant advantage over single-nostril administration.

[Treatment of tumor pain with flupirtine. Results of a double-blind study versus tramadol]. / Behandlung von Tumorschmerzen mit Flupirtin. Ergebnisse einer Doppelblindstudie versus Tramadol.

STUDY DESIGN: In a multicentric double-blind trial, flupirtine was compared with tramadol in the treatment of cancer pain. METHODS: Over a period of four weeks, 4 (-6) capsules containing either 100 mg flupirtine (n = 35) or 50 mg tramadol (n = 36) were taken daily in accordance with a fixed time schedule. Severity of pain was scored on a weekly basis using a five-stage verbal scale. RESULTS: Initially comparable in the two groups, pain was more markedly reduced after four weeks of treatment with flupirtine than after tramadol, the need for additional analgesic drugs also being less in the flupirtine group. The final general assessment by the attending doctors of the results achieved was "good" to "very good" in 63% of the patients on flupirtine, and in 46% of those on tramadol. Undesired effects were observed in 6% of the flupirtine patients and in 19% of those taking tramadol.

Treatment of acute migraine with subcutaneous GR43175 in West Germany.

A subcutaneous preparation of GR43175, a novel antimigraine 5-HT 1-like agonist, was considered to represent a convenient way of administering the drug to patients during an acute migraine attack. In a series of open, uncontrolled dose-ranging studies, 82 patients with migraine were assessed serially for changes in severity of headache and associated symptoms following subcutaneous GR43175 in doses of 1-4 mg. Subcutaneous injection of 3 mg or 4 mg was found to be most effective. Within 60 min, 90% of patients had obtained complete relief of all migraine symptoms. Tolerability was good, 59% of patients reporting no adverse effects. Those reported mainly comprised transient local irritation to the injection. There were no changes attributable to GR43175 in heart rate, blood pressure, ECG readings or laboratory parameters.

[The "pain pen", a semiautomatic morphine injection system for subcutaneous self-administration. Technique and first results.]. / Anwendungstechnik und erste Ergebnisse mit dem "Pain-Pen", einem halbautomatischen Morphin-Injektionssystem zur subkutanen Selbstapplikation.

Subcutaneous self-administration of morphine with a "pain pen", a semiautomatic mechanical injection system about the size of a penholder, was tested in nine patients with severe chronic pain of malignant origin. During a period of treatment of 12-100 days (on an outpatient basis in three patients) side-effects of subcutaneous morphine could only be observed during a short-lasting initial period of adaptation. The average daily dosage of morphine was between 11.3+/-7.2 mg (lowest daily demand) and 20.7+/-10.5 mg (highest daily demand). Pain scaling (NSR 101) demonstrated a significant pain reduction from 80+/-19.3 to values between 5.5+/-8.3 (lowest score) and 39.4+/-14.2 (highest score during subcutaneous therapy). There were no hygienic problems, and the patients learned the technique of self-injection within a few days. This system may be especially suitable for patients with gastrointestinal incompatibility of oral opiate preparations, e.g. patients with multiple drug intake.

[The pharmacokinetics of continuous peridural morphine infusion]. / Pharmakokinetik der kontinuierlichen periduralen Morphininfusion.

In patients with cancer pain treated by continuous epidural opiate infusion (4.5-24 mg morphine per day) via implanted or portable pumps (n = 40) plasma levels of morphine were determined during the postoperative period and during regular refill of the pump systems. Concentrations were between 2.6 and 18.8 ng/ml depending on daily dosage and body weight. There were no signs of accumulation. Concentrations in lumbar CSF measured in some of the patients were 15-20 higher but decreased by 10-20% (in relation to daily dosage) in the course of long-term treatment. This may be induced by reduction in permeability of the dura due to fibrosis within the epidural space after chronicle catheterization. Cervical CSF concentrations (during chordotomy) were about 1/6 to 1/7 of the corresponding lumbar CSF levels. It may be assumed that epidural opiate infusion in spite of low blood levels is accompanied by relevant cerebral opiate actions.

[Effect of neuroleptanalgesia on the visual evoked potential (VEP) in man]. / Der Einfluss der Neuroleptanalgesie auf das visuelle evozierte Potential (VEP) des Menschen.

Visual evoked potentials (VEP) were monitored intraoperatively in 35 urological patients during modified neuroleptanalgesia. Control measurements were made in 18 awake, premedicated patients prior to induction of anesthesia. The latencies of the negative peaks (designed n1, n2, n3) increased significantly (p = 0.001) during anesthesia: n1 from 50,6 ms to 57,1 ms, n2 from 80 ms to 89,4 ms, n3 from 124,5 ms to 139,6 ms, no significant change in amplitude was seen. Changing paCO2 in the range from 20 mmHg to 50 mmHg during controlled ventilation did not affect latencies and amplitudes of visual evoked potentials (n = 10 patients). These influences of neuroleptanalgesia must be considered when recording visual evoked potentials intraoperatively during neurosurgical procedures (aneurysm-, pituar gland surgery) for monitoring optic nerve function.

[Labetalol for the management of hypertensive crises during surgery of cerebral aneurysm; a haemodynamic study (author's transl)]. / Hämodynamische Untersuchungen von Labetalol zur intraoperativen Therapie hypertoner Krisen in der Chirurgie zerebraler Aneurysmen.

The haemodynamic effects of Labetalol, an alpha- and beta blocking agent were investigated during neurosurgery in 11 patients with cerebral aneurysm and hypertensive episodes. All operations were performed in neuroleptanalgesia and controlled ventilation (PaCO2 = 30 mmHg). Immediately after intravenous injection of Labetalol there was a significant fall in the following haemodynamic parameters: arterial pressure -20 percent, pulmonary artery pressure -17 per cent, heart work index (right ventricle -32 percent, left ventricle -30 percent) and cardiac effort index -25 percent. Heart rate, cardiac index, stroke volume, total systemic and total pulmonary resistance were not appreciably altered. Labetalol appears to be of value in neurosurgical operations, where an increase in blood pressure, heart rate and myocardial oxygen consumption is undesirable.

[Haemodynamic effect of naloxone during electrostimulation analgesia with special reference to the role of endorphin (author's transl)]. / Hämodynamische Untersuchung unter Naloxone während der Elektrostimulationsanalgesie (ESA) als Beitrag zur Endorphintheorie.

10 persons undergoing cardiac surgery in electro-stimulation analgesia (ESA) with controlled ventilation were given 5 microgram/kg bodyweight and 10 microgram/kg body-weight respectively of naloxone during the operation and the effects of the drug on the circulation were registered over a period of 10 minutes. The observations do not support the view that endorphin plays a part in ESA. Other possible modes of action are discussed.