American journal of therapeutics
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Randomized Controlled Trial Comparative Study
Intrathecal bupivacaine in comparison with a combination of nalbuphine and bupivacaine for subarachnoid block: a randomized prospective double-blind clinical study.
We performed this randomized, prospective double-blind study to evaluate the effects of 2 different doses of intrathecal nalbuphine (a synthetic opioid agonist-antagonist) on the onset, duration of action, side effects, and complication produced by intrathecal hyperbaric 0.5% bupivacaine in lower abdominal, urologic and lower limb surgeries. Seventy-five patients of ASA grades 1 and 2 of either sex in the age group of 20-60 years were randomly allocated to 1 of 3 groups. Group A (n = 25) received 2.5 mL of 0.5% hyperbaric bupivacaine + 1 mL sterile water intrathecally; group B (n = 25) received 2.5 mL of 0.5% hyperbaric bupivacaine + 1 mL (200 μg) nalbuphine intrathecally; group C (n = 25) received 2.5 mL of 0.5% hyperbaric bupivacaine + 1 mL (400 μg) nalbuphine intrathecally. ⋯ One patient in group A had nausea and vomiting, 2 patients in each group developed shivering (P > 0.05). No other side effect or complication was observed. Nalbuphine hydrochloride (400 μg) significantly prolongs the duration of sensory blockade and postoperative analgesia without any side effect or complication when introduced intrathecally along with hyperbaric bupivacaine.
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Randomized Controlled Trial Multicenter Study Comparative Study
A double-blind, randomized, multicenter, dose-ranging study to evaluate the safety and efficacy of fospropofol disodium as an intravenous sedative for colonoscopy in high-risk populations.
Fospropofol is a sedative hypnotic with a slower onset and longer duration of action. Fospropofol has demonstrated successful dose-dependent sedation at 6.5 mg/kg. This study evaluated the efficacy and safety of a lower weight-adjusted dose compared with the approved dose (4.875 or 6.5 mg/kg depending on patient subgroup) in high-risk elderly patients undergoing colonoscopy. ⋯ The rate of sedation, modified sedation, and treatment success were higher in patients administered the approved dose for all the subgroups. No clinically significant advantage was demonstrated using a lower modified dose in this study population. The approved dose is recommended in the elderly, more obese, and high-risk patients when used for moderate sedation.
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Randomized Controlled Trial
Pregabalin for the treatment of abdominal adhesion pain: a randomized, double-blind, placebo-controlled trial.
Chronic pain related to postoperative abdominal adhesions is a common problem with no standard analgesic regimen currently established. In a double-blind, placebo-controlled trial, we examined the effects of pregabalin on pain modulation in patients with prior abdominal surgery and documented adhesion. The primary outcome measure was pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption. ⋯ The pain score result from the blinded phase setting indicated that the amount of decrease was significantly greater in the drug group (P = 0.024), whereas the pain score result from the open-label setting indicated that the amount of decrease was significantly greater in the placebo group (P = 0.043). Only the sleep score result in the open-label setting was significantly greater in the placebo group (P = 0.024). We conclude that pregabalin significantly reduced patient-documented pain scores compared with placebo in our small cohort of patients with abdominal adhesion pain.
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Randomized Controlled Trial Comparative Study
A randomized double blind study to evaluate efficacy of palonosetron with dexamethasone versus palonosetron alone for prevention of postoperative and postdischarge nausea and vomiting in subjects undergoing laparoscopic surgeries with high emetogenic risk.
Postoperative nausea and vomiting (PONV) and postdischarge nausea and vomiting (PDNV) are common occurrences (50%-80%) after laparoscopic surgery. Palonosetron (Pal), the newest 5-HT3 antagonist, is an effective antiemetic that has advantages in treating PDNV due to its prolonged duration of action. We hypothesized that a combination of Pal and dexamethazone (Dex) could further improve the efficacy of the treatment in comparison to Pal alone in patients at high risk for PONV. ⋯ The Pal + Dex group showed a trend toward greater satisfaction on the QOL- Functional Living Index-Emesis scores with the greatest differences in the "nausea domain". The combination therapy of palonosetron + dexamethasone did not reduce the incidence of PONV or PDNV when compared with palonosetron alone. There was no change in comparative efficacy over 72 hours, most likely due to the low incidence of PDNV in both groups.
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Randomized Controlled Trial Comparative Study
Pharmacokinetic studies in women of 2 novel oral formulations of tranexamic acid therapy for heavy menstrual bleeding.
Two randomized, open-label clinical studies involving healthy female volunteers aged 18-45 years (study 1, N = 32; study 2, N = 40) are described, which characterize the pharmacokinetics and steady-state dosage regimen performance of 2 novel, modified-release tranexamic acid tablet formulations. The objective of these studies was to identify the optimum product formulation to advance into late-phase clinical trials for heavy menstrual bleeding. For study 1, participants received single 1.3-g doses (2 650-mg tablets) of tranexamic acid modified-immediate-release (MIR) and tranexamic acid delayed-release (DR) formulations under fasting conditions compared with nonfasting conditions (after breakfast). ⋯ Peak systemic exposure and maintenance of plasma tranexamic acid concentrations within the therapeutic range (5-15 μg/mL) were optimally achieved with 1.3 g of the MIR formulation dosed every 8 hours. The MIR and DR formulations were well tolerated. Peak-to-trough steady-state performance of the tranexamic acid MIR 1.3-g product (dosed every 8 hours, or 3 times daily, for up to 5 days) supported its advancement to late-phase clinical trials in women with heavy menstrual bleeding.