Thoracic epidural for post-thoracotomy pain: a comparison of three concentrations of sufentanil in bupivacaine

ABSTRACT. Background:The aim of this prospective, double blind, randomised trial was to compare the analgesic and adverse effectsof three concentrations of the thoracic epidural sufentanil with bupivacaine in patients undergoing thoracotomy.Methods:We studied 60 (randomised) patients who were to receive a 10 ml bolus dose of sufentanil, 1µg/ml, 2 µg/ml and3 µg/ml, in bupivacaine 0.125%, via thoracic epidural. Postoperatively, pain at rest, on coughing and with ambulation wasassessed using a visual analogue scale (VAS) and observer verbal ranking score (OVRS) at 2, 6, 12 and 24 hours. Adverseeffects were simultaneously assessed.Results:There was no significant difference in the baseline characteristics between the three groups. The number of patientswith episodes of unsatisfactory pain, i.e. a VAS scores ≥ 40 and OVRS ≥ 2, at each of the four assessments postoperatively,was significantly higher with sufentanil 1 g/ml than with sufentanil 2 µg/ml or µ3 g/ml (p < 0.05). In the 3 µg/ml sufentanilgroup, four patients (20%) had a sedation score ≥ 3 compared with one (5%) and no (0%) patients in the 2 µg/ml and1 µg/ml sufentanil groups, respectively (p < 0.05). In addition, 30% patients experienced pruritus in the 3 µg/ml sufentanilgroup compared with 10% and 5%, respectively, in the 2 µg/ml and 1 µg/ml sufentanil groups. In the sufentanil 3 µg/ml,2 µg/ml and 1 µg/ml groups, 30%, 20% and 5% patients, respectively, had emetics symptoms (p < 0.05).Conclusions:We conclude that a thoracic epidural bolus of 10 ml sufentanil 2 µg/ml with bupivacaine 0.125% provides theoptimal balance between pain relief and side-effects following thoracotomy

Post-Marketing Stability Surveillance: Amoxicillin

Background: To ensure the successful treatment of infectious disease using antimicrobial therapy; a sufficient concentration of the stable; active drug is required at the site of infection. For the achievement of this with respect to the Beta-lactam group of antibiotics; of which amoxicillin is a member; the presence of an intact Beta-lactam ring is essential. Destruction of this sensitive ring can lead to the ingestion of an inactive drug. This can contribute to treatment failure and antibiotic resistance. Thus; the aims of this study were to determine whether the types of packaging in which amoxicillin preparations are dispensed and the temperature and humidity conditions under which they are stored by patients are adequate and appropriate to ensure drug stability.Methods: A mini-survey of pharmacies and patients was conducted in order to determine the types of packaging in which amoxicillin preparations are dispensed and the temperature and humidity conditions under which they are stored by patients. The amoxicillin preparations in the identified types of packaging were subjected to simulated conditions that represented the identified temperature and humidity stresses that occurred under patient storage conditions for a duration of 14 days. The extent of breakage of the Beta-lactam ring was then chemically determined on day 1; day 7 and day 14; using an iodometric titration method.Results: The mini-survey identified four types of packaging in which amoxicillin capsules are dispensed - plastic packets; flip-top amber bottles; flip-top amber bottles with cotton wool and flip-top transparent bottles with cotton wool. The laboratory analyses showed that only those amoxicillin capsules stored between 20 and 25 0C and protected from moisture were stable in all four identified types of packaging for 14 days. The mini-survey also indicated that 47 of the patient sample did not store their antibiotic suspensions in the refrigerator. The laboratory analyses showed that only amoxicillin suspensions stored between 2 and 8 0C for seven days showed the lowest level of degradation.Conclusion: The results of this study indicate that reconstituted amoxicillin suspensions should be stored in the temperature range 2 to 8 0C; and that the reconstitution and dispensing of a 14-day supply of amoxicillin suspensions should be discouraged; even if the drug is stored in this temperature range. For amoxicillin capsules; the results obtained in this study indicate that significant breakage of the Beta-lactam ring of amoxicillin capsules can occur in hot and humid climatic conditions if inadequate types of packaging are used and storage occurs under inappropriate conditions. The results of the study point to the importance of drug stability knowledge as a prerequisite for the dispensing of medicines; the importance of the provision of patient counselling with regard to drug storage requirements; as well as a requirement for amoxicillin capsules to be dispensed in the original manufacturers' containers in geographical areas that are hot and humid