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
Randomized Controlled Trial Comparative Study Clinical TrialComparison of ketorolac and meperidine in patients with postoperative pain--impact on health care utilization.
A double-blind, randomized study was conducted to compare the effects of intramuscular ketorolac tromethamine and meperidine hydrochloride, and subsequent oral pain medication, on health care utilization and postoperative recovery. Following abdominal hysterectomy or cholecystectomy, 210 patients (aged 18 to 70 years; 189 women, 21 men) were randomly assigned to therapy and evaluated for efficacy, safety, nursing care requirements, functional independence, recovery milestones, and quality of life. The patients received 30 mg of ketorolac intramuscularly every 3 to 6 hours as needed, followed by 10 mg of ketorolac every 4 to 6 hours, or 100 mg of meperidine intramuscularly every 3 to 6 hours as needed, followed by acetaminophen/codeine (600 mg/60 mg) orally every 4 to 6 hours. ⋯ Mean pain intensity difference (from baseline) scores and pain relief scores when adjusted for baseline pain severity were comparable between ketorolac and meperidine. Most adverse events reported by the patients were mild to moderate; 12 patients in each group withdrew from treatment because of adverse events (nausea, rash, or headache). It is concluded that ketorolac is an effective alternative to meperidine in the management of postoperative pain.
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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 Clinical TrialReversal of central benzodiazepine effects by intravenous flumazenil after conscious sedation with midazolam and opioids: a multicenter clinical study. The Flumazenil in Intravenous Conscious Sedation with Midazolam Multicenter Study Group II.
The efficacy and safety of flumazenil in antagonizing the central effects of the benzodiazepine midazolam was demonstrated in patients in whom conscious sedation was induced with midazolam plus an opioid (fentanyl, meperidine, or morphine). In a double-blind, multicenter study, 240 patients were administered flumazenil postoperatively at an average intravenous dose of 0.7 mg (7 ml) and 114 patients were administered an average dose of 9 ml placebo. Complete reversal of sedation was observed in 80% of flumazenil-treated patients and 30% of placebo-treated patients 5 minutes posttreatment. ⋯ Flumazenil was well tolerated, although adverse effects were reported slightly more often than in the placebo group. The most frequent adverse events in both groups were dizziness and nausea. Vital signs were not affected.
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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 premedicated with an opioid and a muscle relaxant: report of a multicenter double-blind clinical study. The Flumazenil in General Anesthesia in Outpatients Study Group II.
Flumazenil was studied in a double-blind multicenter trial to confirm its efficacy and safety in antagonizing the central effects of benzodiazepines after general anesthesia (midazolam, short-acting narcotic, nitrous oxide) with muscle relaxants and selected potent volatile anesthetics as needed. One hundred seventy-two outpatients were randomly assigned to receive either flumazenil or placebo titrated to the point of reversal of sedation or a maximum dose of 1 mg of flumazenil or 10 ml of placebo. The test drug was given intravenously (0.2 mg flumazenil or 2 ml placebo) at 1-minute intervals. ⋯ Only 6 adverse effects in the flumazenil group and 1 in the placebo group were considered severe; the remainder were mild or moderate. None were considered serious or potentially serious. Postoperative administration of flumazenil (mean dose, 0.85 mg) safely provided a prompt, controlled reversal of the sedative and psychomotor effects of midazolam in most patients.