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Please use this identifier to cite or link to this item: https://hdl.handle.net/11055/930
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dc.contributor.authorSalman Sen_US
dc.contributor.authorTang EKYen_US
dc.contributor.authorCheung LCen_US
dc.contributor.authorNguyen MNen_US
dc.contributor.authorSommerfield Den_US
dc.contributor.authorSlevin Len_US
dc.contributor.authorLim LYen_US
dc.contributor.authorvon Ungern Sternberg BSen_US
dc.date2018-07-09-
dc.date.accessioned2020-07-01T04:09:24Z-
dc.date.available2020-07-01T04:09:24Z-
dc.identifier.citation73(12):1469-1477en_US
dc.identifier.urihttp://hdl.handle.net/11055/930-
dc.description.abstractMidazolam is one of many bitter drugs where provision of a suitable oral paediatric formulation, particularly in the pre-anaesthetic setting, remains a challenge. To overcome this problem, a novel chocolate-based tablet formulation has been developed with positive pre-clinical results. To further investigate the potential of this formulation, 150 children aged 3-16 years who were prescribed midazolam as a premedication were randomly assigned to receive 0.5 mg.kg-1 either as the novel formulation or an intravenous solution given orally, which is the current standard at our institution. Tolerability was assessed by each child, parent and nurse using a 5-point facial hedonic scale and efficacy was determined as the time to onset of sedation. Blood samples for midazolam and 1-hydroxymidazolam levels were analysed using high-performance liquid chromatography. Population pharmacokinetics were evaluated using non-linear mixed effects modelling. The novel formulation had significantly improved tolerability scores from children, parents and nurses (all p < 0.001). Time to effect was not different between the groups (p = 0.140). The pharmacokinetics of midazolam and 1-hydroxymidazolam were able to be modelled simultaneously. The novel formulation was subject to a higher estimated first-pass metabolism compared with the intravenous solution (8.6% vs. 5.0%) and a significantly lower relative bioavailability of 82.1% (p = 0.013), with no other significant differences. Exposure relative to dose was in the range previously reported for midazolam syrup. We conclude that the novel chocolate-based formulation of midazolam provides improved tolerability while remaining efficacious with suitable pharmacokinetics when used as a premedicant for children.en_US
dc.subjectMidazolamen_US
dc.subjectPaediatricsen_US
dc.subjectDrug Compoundingen_US
dc.subjectTasteen_US
dc.titleA novel, palatable paediatric oral formulation of midazolam: pharmacokinetics, tolerability, efficacy and safety.en_US
dc.typeJournal Articleen_US
dc.type.contentTexten_US
dc.identifier.journaltitleAnaesthesiaen_US
dc.identifier.doi10.1111/anae.14318en_US
dc.description.affiliatesUniversity of Western Australiaen_US
dc.description.affiliatesCurtin Universityen_US
dc.description.affiliatesPrincess Margaret Hospital for Childrenen_US
dc.description.pubmedurihttps://www.ncbi.nlm.nih.gov/pubmed/29984832en_US
dc.type.studyortrialRandomized Controlled Clinical Trial/Controlled Clinical Trialen_US
dc.ispartof.anzcaresearchfoundationYesen_US
item.grantfulltextnone-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.cerifentitytypePublications-
Appears in Collections:Scholarly and Clinical
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