Clinical drug investigation
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Randomized Controlled Trial
Efficacy of granisetron for the treatment of postoperative nausea and vomiting in women undergoing breast surgery: a randomised, double-blind, placebo-controlled trial.
Women undergoing general anaesthesia for breast surgery are especially at risk of experiencing postoperative nausea and vomiting (PONV). This study was undertaken to assess the efficacy of granisetron, a selective serotonin type 3 receptor antagonist, for the treatment of postoperative nausea and vomiting after breast surgery. ⋯ The minimum effective dose of granisetron for the treatment of PONV in women undergoing breast surgery was 20 microg/kg. Increasing the granisetron dose to 80 microg/kg provided no further benefit.
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Comparative Study
A prospective survey to compare the suitability profiles of over-the-counter ibuprofen and paracetamol use in a French general practitioner-controlled population.
The PAIN (Paracetamol, Aspirin and Ibuprofen New tolerability) study published in 1999 assessed the tolerability of over-the- counter (OTC) analgesics in a French general practitioner (GP)-controlled population and found no apparent difference between the tolerability of ibuprofen and paracetamol (acetaminophen). However, patient selection in that study could cast doubt over the relevance of the results to a more generalised OTC population. The aim of our survey was to prospectively determine what proportion of a French GP-controlled population is able to take ibuprofen and paracetamol in order to allow appropriate interpretation of the PAIN study. ⋯ Our survey demonstrates how careful patient selection can limit the generalisability of a study. The PAIN study excluded individuals 'at-risk' from ibuprofen and the tolerability results of this study should therefore be interpreted with extreme caution because the patient population may not be representative of unsupervised OTC analgesic users.
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Randomized Controlled Trial
Long-term safety of intravenous ibandronic acid for up to 4 years in metastatic breast cancer: an open-label trial.
Despite their widespread use in metastatic bone disease, some bisphosphonate drugs are associated with adverse events (AEs), particularly renal toxicity, adding to treatment burdens and increasing healthcare costs. Ibandronic acid is a single-nitrogen bisphosphonate with high efficacy against bone events and metastatic bone pain, and a renal safety profile compar- able to that of placebo. In this study, the safety of ibandronic acid was examined over a period of 4 years. ⋯ This 96-week open-label safety extension of a phase III, placebo-controlled trial demonstrates that long-term use of intravenous ibandronic acid is well tolerated.
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Breast surgery performed under general anaesthesia is associated with a high incidence of postoperative nausea and vomiting (PONV). Between 60% and 80% of patients undergoing mastectomy (with axillary dissection) experience PONV. Pharmacological approaches have been investigated to reduce PONV after breast surgery. ⋯ Overall, these pharmacological and non-pharmacological approaches reduce the incidence of PONV following breast surgery. Most of the published trials indicate improved prophylaxis of PONV following breast surgery by avoiding risk factors, and by using effective antiemetic agents in women scheduled for mastectomy (with axillary dissection). The clinician must weigh the benefits of using pharmacological and non-pharmacological approaches for PONV against the risk of occurrence of adverse events.
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Botulinum toxin type A has been shown to relieve primary headaches, myofascial pain and various neuropathic pains. Carpal tunnel syndrome (CTS) is a common disorder resulting from median nerve compression at the wrist. As reports of botulinum toxin A in the treatment of CTS were limited, this study set out to evaluate the safety and tolerability of botulinum toxin A and its effects on the relief of nerve entrapment and pain in patients with CTS. ⋯ Our data suggest long-lasting antinociceptive effects of botulinum toxin A rather than electrophysiological restoration in patients with CTS. Intracarpal injection of botulinum toxin A was shown to be well tolerated and safe. A double-blind, placebo-controlled trial of botulinum toxin A in CTS is warranted since the current study may have been confounded by the placebo effect of intracarpal injection.