Clinical therapeutics
-
Clinical therapeutics · Sep 1993
Randomized Controlled Trial Clinical TrialA double-blind, randomized study of naproxen sodium, ibuprofen, and placebo in postoperative dental pain.
In a double-blind, parallel, placebo-controlled study, 203 patients with post-operative dental pain following the extraction of one or two bony impacted third molars were randomized to receive a single dose of naproxen sodium 220 mg, ibuprofen 200 mg or placebo. Pain intensity and pain relief were assessed at intervals for 12 hours postdose. ⋯ From 1 to 12 hours postdose, naproxen sodium showed a trend for superior analgesic efficacy compared with ibuprofen; this trend reached statistical significance at the 12-hour time point. Both drugs were well-tolerated and effective analgesics for postoperative dental pain.
-
Clinical therapeutics · May 1993
Randomized Controlled Trial Clinical TrialA randomized vehicle-controlled trial of topical capsaicin in the treatment of postherpetic neuralgia.
A large double-blind, vehicle-controlled study of 143 patients with chronic postherpetic neuralgia (PHN) was performed to evaluate the degree of efficacy of topically applied capsaicin 0.075% cream. In addition, the safety and efficacy of long-term application of topical capsaicin in PHN was assessed by following patients in an open-label study for up to 2 years. In the double-blind phase, 143 patients with PHN of 6 months' duration or longer were enrolled. ⋯ Data from the long-term, open-label phase (up to 2 years, n = 77), which immediately followed the 6-week blinded phase, showed that the clinical benefit in patients treated for a short (6-week) period with topical capsaicin could be maintained or amplified in most patients (86%) during prolonged therapy. There were no serious adverse effects observed or reported throughout the trial; in fact, the only side effect associated with capsaicin treatment was the burning or stinging at local sites of application (in 9% of patients) during exposures of up to 2 years (long-term phase). On the basis of these data, we conclude that capsaicin 0.075% cream is a safe and effective treatment for the pain of postherpetic neuralgia and should be considered for initial management of patients with this condition.
-
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.
-
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.
-
Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialTreatment of benzodiazepine overdose with flumazenil. The Flumazenil in Benzodiazepine Intoxication Multicenter Study Group.
Flumazenil, a specific benzodiazepine antagonist, was evaluated as adjunctive therapy in the management of benzodiazepine overdose. Thirteen emergency departments enrolled 326 patients in this double-blind, placebo-controlled trial; 162 patients were randomly allocated to receive flumazenil (maximum dose, 30 ml, providing 3 mg of flumazenil), and 164 were allocated to receive placebo (maximum dose, 30 ml). A successful response was the attainment of a score of 1 or 2 on the Clinical Global Impression Scale (CGIS), denoting a very much improved or much improved status, 10 minutes after the start of intravenous administration of the test drug. ⋯ This was accomplished irrespective of the presence of coingested drugs. Flumazenil is not recommended for patients with serious cyclic antidepressant poisoning or those who use benzodiazepines therapeutically to control seizure disorders. When used as recommended, however, flumazenil has been shown to have an acceptable safety level.