4Ms Study Version 6, Date 29 October 2014
Research type
Research Study
Full title
Midazolam Measurement and Modelling using Matrix Samplers (The 4Ms Study)
IRAS ID
140935
Contact name
Hitesh Pandya
Contact email
Sponsor organisation
University of Leicester
Eudract number
2014-004958-34
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Midazolam is a sedative drug. In children, it is commonly used to reduce stress and discomfort associated with clinical procedures for example surgery. It is also used to alleviate discomfort in critically-ill children attached to ventilators in intensive care.
Midazolam treatment is known to cause side effects such as respiratory depression and drug withdrawal particularly when it is given for prolonged periods intravenously (IV). This indicates that recommended doses for IV midazolam may be too high for some children. Personalising midazolam doses for children could reduce the incidence of adverse events and so improve outcomes.
Midazolam dosing recommendations for children have been developed through a series of studies which have identified factors e.g. liver failure that clinicians should take into account when dosing individuals. Presently, IV midazolam doses for children are determined using the child’s weight only and not personalised to their individual characteristics.
The aim of this study is to determine whether an established computer software package, called SPS, predicts blood midazolam levels in two different groups of children. Group 1 comprises of well children receiving IV midazolam in surgical theatre and Group 2 comprises of critically-ill children receiving IV midazolam in intensive care. Actual blood midazolam levels will be compared with SPS-predicted values in these two patient groups. The comparisons will then be used to determine whether critical-illness has a major effect on midazolam levels and so whether blood midazolam dosing should be altered in critically-ill children. This is a ‘proof of concept’, observational study. The data generated from this study will not be used to change the children dosing regimen for Midazolam.
Children involved in this study will receive IV midazolam as part of their routine clinical care. They will have no more than 1 ml of extra blood taken for the purposes of the study.REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/1261
Date of REC Opinion
16 Dec 2014
REC opinion
Further Information Favourable Opinion