Clinical therapeutics
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Clinical therapeutics · May 1993
Randomized Controlled Trial Clinical TrialPain relief after dental impaction surgery using ketorolac, hydrocodone plus acetaminophen, or placebo.
In a double-blind, placebo-controlled study, 207 patients with moderate pain after surgical removal of impacted third molars were randomly assigned to receive a single oral dose of 10 mg of ketorolac tromethamine, 10 mg of hydrocodone plus 1000 mg of acetaminophen, or placebo. Analgesic effect as assessed by summed pain intensity difference at 3 and 6 hours was significantly (P < or = 0.01) greater after ketorolac than after hydrocodone/acetaminophen. ⋯ In this single-dose study, adverse events were reported more frequently by patients taking hydrocodone/acetaminophen than with ketorolac or placebo. It is concluded that, in this pain model, 10 mg of ketorolac affords better pain relief with fewer side effects than hydrocodone/acetaminophen.
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Clinical therapeutics · May 1993
Comparative StudyEfficacy and tolerability of a combination of enalapril and hydrochlorothiazide in the treatment of hypertension measured manually and with an ambulatory blood pressure monitor.
The efficacy and tolerability of an enalapril maleate-hydrochlorothiazide combination (EM-HCTZ) were evaluated in a prospective, open-label study in 26 patients with uncomplicated essential hypertension (mean baseline sitting systolic/diastolic blood pressure: 153/103 mmHg) requiring two agents to reduce sitting diastolic blood pressure (SDBP) below 90 mmHg. Their mean age was 52 years. Patients received enalapril 5 mg daily, which was increased to 10 mg if SDBP was not reduced to < 90 mmHg during a 5-week titration period following washout. ⋯ Following treatment with EM-HCTZ, mean diastolic blood pressure fell 10 mmHg and mean systolic blood pressure fell 15 mmHg. In summary, EM-HCTZ was highly effective and generally well-tolerated in a substantial proportion of participants whose SDBP remained > 90 mmHg on enalapril 10 mg. Important differences between blood pressure measured manually and with a monitor were also demonstrated.
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Clinical therapeutics · Mar 1993
Use of a prefilled insulin syringe (Novolin Prefilled) by patients with diabetes.
A study was conducted to assess patients' acceptance of a new insulin injection system, Novolin Prefilled, and to record their opinions about its use during a 4-week study period. Sixty-four patients, aged 20 to 69 years, with type I (n = 19) or type II (n = 45) diabetes mellitus entered and completed the study; 22 were new insulin users and 42 had been treated previously for 6 months to 43 years. Patients received insulin treatment via a prefilled syringe that was designed to provide a convenient alternative method for injecting insulin. ⋯ The results of attitude questionnaires revealed that after treatment significantly more patients (P < 0.05) reported feeling energetic and full of pep, in good control, and not worried about giving themselves insulin injections. The increase in positive attitudes was most apparent among the patients new to insulin use. Most of the study patients (98%) reported that the prefilled syringe was convenient and easy to use, 95% found it took less time to use at home, and 91% wished to continue using it for insulin delivery.(ABSTRACT TRUNCATED AT 250 WORDS)
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialReversal of central benzodiazepine effects by flumazenil after intravenous conscious sedation with diazepam and opioids: report of a double-blind multicenter study. The Flumazenil in Intravenous Conscious Sedation with Diazepam Multicenter Study Group II.
The efficacy and safety of a new benzodiazepine antagonist, flumazenil, were assessed in a double-blind multicenter study. Flumazenil (mean dose, 0.76 mg) or placebo (mean dose, 8.9 ml) was administered intravenously to 130 and 67 patients, respectively, who had been given diazepam in conjunction with an opioid (fentanyl, meperidine, or morphine) for the induction and maintenance of intravenous conscious sedation for diagnostic or therapeutic surgical procedures. The group assessable for efficacy comprised 122 patients treated with flumazenil and 64 patients given placebo. ⋯ Thirty-nine (30%) of flumazenil-treated patients, compared with 17 (25%) of placebo-treated patients had one or more drug-related adverse experiences. The most common adverse effects were nausea and vomiting in the flumazenil group and nausea and injection-site pain in the placebo group. Flumazenil was found to promptly reverse sedation induced by diazepam in the presence of opioids.
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialReversal of the central effects of midazolam by intravenous flumazenil after general anesthesia in outpatients: a multicenter double-blind clinical study. The Flumazenil in General Anesthesia in Outpatients Study Group I.
In a US double-blind, multicenter study, flumazenil, a benzodiazepine antagonist, administered postoperatively in a mean intravenous dose of 0.67 mg (range, 0.2 to 1 mg), was superior to placebo in reversing sedation and other central nervous system effects of benzodiazepines in outpatients recovering from general anesthesia induced by midazolam, fentanyl or sufentanil, and nitrous oxide. Within 5 minutes after administration of flumazenil, sedation was reversed in 94% (87 of 93) of flumazenil-treated patients, compared with 13% (6 of 46) of placebo-treated patients. The criterion response (Observer's Assessment of Alertness/Sedation Scale score of 4 or 5) that was achieved at 5 minutes was maintained in 79 (93%) of 85 patients throughout the 180-minute observation period. ⋯ Patients given flumazenil did not experience more pain at the operative site or require more analgesic medication than did those given placebo. Nausea (flumazenil 24%; placebo 15%), dizziness (flumazenil 12%; placebo 2%), and vomiting (flumazenil 10%; placebo 9%) were the most frequent adverse effects in each group. In conclusion, flumazenil provided prompt arousal from benzodiazepine-induced sedation and was well tolerated.