Midazolam Microtracer PK study in children up to 2 years old
Research type
Research Study
Full title
Midazolam Paediatric Accelerator Mass Spectrometry Evaluation Research Study (PAMS): a multi-centre clinical study to evaluate the use of a microtrace dose of 14C-labelled midazolam and Accelerator Mass Spectrometry (AMS) bioanalysis as new tools in drug development to determine pharmacokinetics in neonates, infants and toddlers.
IRAS ID
139949
Contact name
M Turner
Contact email
Sponsor organisation
Liverpool Women's NHS Foundation Trust
Research summary
There is an urgent need to ensure that medicines used in children are assessed adequately. A range of methods have been proposed to meet this need. One of these methods has been tested in adults but not in young children. This study examines microtracer dosing with accelerator mass spectrometry (AMS). A microtracer is a very small amount of study drug that has been labelled with a vanishingly small amount of radioactivity. AMS is a very sensitive way of measuring radioactivity. Single atoms can be detected. This allows such small amounts of radioactivity to be used that the radioactivity poses no risks to patients, families or staff. We will use midazolam as a model drug to find out what happens when midazolam is given to babies, infants and toddlers. The data obtained with the new method will be compared with data in the literature that was obtained using standard methods. This could establish a way for AMS studies to be incorporated into the development of new drugs so that new treatments can be given to children more quickly than with current approaches.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0839
Date of REC Opinion
19 Dec 2013
REC opinion
Favourable Opinion