Clinical therapeutics
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Clinical therapeutics · Jun 2016
Randomized Controlled TrialRescue Sedation With Intranasal Dexmedetomidine for Pediatric Ophthalmic Examination After Chloral Hydrate Failure: A Randomized, Controlled Trial.
It is a challenge to rescue ophthalmology examinations performed in children in the sedation room after initial chloral hydrate failure. Intranasal dexmedetomidine can be used in rescue sedation in children undergoing computed tomography. The present study aimed to assess the efficacy and tolerability of intranasal dexmedetomidine use in children undergoing ophthalmic examination after chloral hydrate failure. ⋯ In children undergoing ophthalmic examination, intranasal dexmedetomidine can be administered in the sedation room for rescue sedation after chloral hydrate failure, with the 2-μg/kg dose being more efficacious than the 1-μg/kg dose, as measured by success rate. ClinicalTrials.gov identifier: NCT02077712.
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Clinical therapeutics · Jun 2016
Randomized Controlled TrialLorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis.
Lorcaserin is a selective serotonin 2C receptor (5-HT2C) agonist approved in the United States for use in chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity. Its pharmacologic activity is limited to 5-HT subtype 2 receptors. The potency of lorcaserin for the 5-HT2C receptor is 14-fold greater than its potency for the 5-HT2A receptor and 61-fold greater than its potency for the 5-HT2B receptor. Although 5-HT receptors have been implicated in serotonin syndrome, the precise pathogenesis is unknown. Given a theoretic risk for this syndrome in patients administered lorcaserin either alone or in combination with certain serotonergic agents (eg, selective serotonin reuptake inhibitors [SSRIs] and serotonin-norepinephrine reuptake inhibitors [SNRIs]), patients taking prohibited serotonergic agents were excluded from the Phase III clinical trials. This retrospective analysis evaluated the tolerability of lorcaserin in patients who took protocol-allowed or proscribed serotonergic agents for varying durations of up to 1 year during the BLOOM, BLOSSOM, and BLOOM-DM studies. ⋯ The concurrent use of lorcaserin and prohibited or allowed serotonergic agents did not appear to have increased the spectrum or intensity of AEs potentially associated with serotonin excess in this limited dataset. However, the sample population was too small to rule out an effect on a rare event such as serotonin syndrome. ClinicalTrials.gov identifiers: NCT00395135, NCT00603902, and NCT00603291.
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Clinical therapeutics · Feb 2016
Randomized Controlled TrialEvaluation of the Pharmacokinetics of Single- and Multiple-dose Buprenorphine Buccal Film in Healthy Volunteers.
Buprenorphine, a partial μ-receptor agonist, is approved for the management of moderate to severe pain, but it has low oral bioavailability. Two open-label studies were performed to determine the pharmacokinetic profile of buprenorphine from buccal film formulations of buprenorphine. ⋯ The absolute bioavailability of BBUP was 46% to 51% across a 16-fold dose range, with dose-proportional increases in systemic exposure. Apparent steady-state conditions occurred within 3 days of dosing. These pharmacokinetic results suggest that therapeutic buprenorphine plasma concentrations can be obtained with BBUP across a wide dose range in a shorter time than other (eg, transdermal) dosage forms.
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Clinical therapeutics · Jan 2016
Randomized Controlled Trial Comparative StudyDexmedetomidine-fentanyl Compared With Midazolam-fentanyl for Conscious Sedation in Patients Undergoing Lumbar Disc Surgery.
Patients undergoing awake lumbar disc surgery need adequate sedation and analgesia. This study investigated whether use of a dexmedetomidine-fentanyl (DF) regimen could be superior to midazolam-fentanyl (MF) for these patients. ⋯ Although awake lumbar disc surgery can be performed successfully under sedation with either MF or DF combination, the latter may be a better alternative because of less consumption of opioid analgesics. ChiCTR.org identifier: ChiCTR-TRC-13003645.
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Clinical therapeutics · Jan 2016
Randomized Controlled TrialMagnesium Sulfate Plus Lidocaine Reduces Propofol Injection Pain: A Double-blind, Randomized Study.
Propofol injection can cause distressing pain, and no method can inhibit it completely. Neither lidocaine nor magnesium sulfate (MgSO4) was sufficient to prevent pain from the injection of propofol. This prospective, double-blind, placebo-controlled study was designed to investigate the efficacy of the MgSO4 plus lidocaine on suppressing propofol injection pain. ⋯ Administration of 300 mg MgSO4 plus 40 mg lidocaine reduces propofol injection pain very well. No complications were observed in the treatment groups.