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https://hdl.handle.net/11055/930
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DC Field | Value | Language |
---|---|---|
dc.contributor.author | Salman S | en_US |
dc.contributor.author | Tang EKY | en_US |
dc.contributor.author | Cheung LC | en_US |
dc.contributor.author | Nguyen MN | en_US |
dc.contributor.author | Sommerfield D | en_US |
dc.contributor.author | Slevin L | en_US |
dc.contributor.author | Lim LY | en_US |
dc.contributor.author | von Ungern Sternberg BS | en_US |
dc.date | 2018-07-09 | - |
dc.date.accessioned | 2020-07-01T04:09:24Z | - |
dc.date.available | 2020-07-01T04:09:24Z | - |
dc.identifier.citation | 73(12):1469-1477 | en_US |
dc.identifier.uri | http://hdl.handle.net/11055/930 | - |
dc.description.abstract | Midazolam 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.subject | Midazolam | en_US |
dc.subject | Paediatrics | en_US |
dc.subject | Drug Compounding | en_US |
dc.subject | Taste | en_US |
dc.title | A novel, palatable paediatric oral formulation of midazolam: pharmacokinetics, tolerability, efficacy and safety. | en_US |
dc.type | Journal Article | en_US |
dc.type.content | Text | en_US |
dc.identifier.journaltitle | Anaesthesia | en_US |
dc.identifier.doi | 10.1111/anae.14318 | en_US |
dc.description.affiliates | University of Western Australia | en_US |
dc.description.affiliates | Curtin University | en_US |
dc.description.affiliates | Princess Margaret Hospital for Children | en_US |
dc.description.pubmeduri | https://www.ncbi.nlm.nih.gov/pubmed/29984832 | en_US |
dc.type.studyortrial | Randomized Controlled Clinical Trial/Controlled Clinical Trial | en_US |
dc.ispartof.anzcaresearchfoundation | Yes | en_US |
item.grantfulltext | none | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.fulltext | No Fulltext | - |
item.openairetype | Journal Article | - |
item.cerifentitytype | Publications | - |
Appears in Collections: | Scholarly and Clinical |
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