Not applicable
Conditions
Interventions
Product Name: Midazolam
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: MIDAZOLAM
CAS Number: 59467-96-8
Conce
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children aged between 1 month (corrected gestational age) and less than 16 years admitted to University Hospitals of Leicester either to Paediatric Intensive Care or for planned surgical procedures requiring general anaesthesia. • Children commenced on intravenous (IV) midazolam therapy by the direct care team. • Parents or legal guardians of children willing to provide written consent for their child to take part in the study. • Where appropriate, children provide written assent to take part in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 130 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Children who refuse assent and children whose parents or legal guardian refuse consent will be excluded from the study. • Any significant disease or disorder which, in the opinion of the direct care team, may either put the participant at risk because of study participation or adversely affect the participant’s ability to participate in the study. • Any significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of study participation, or, influence the result of the study, or, adversely affect the participant’s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Midazolam is a drug with sedative properties. In children, it is used to reduce stress, anxiety and discomfort associated with clinical procedures for example surgery. It is also used to reduce stress and discomfort in critically ill children attached to mechanical ventilators in intensive care. Our long term aim is to develop personalised dosing schedules for children receiving midazolam intravenously. The principal objective of this study is to determine whether criticallyill children metabolise midazolam differently to otherwise healthy children undergoing routine surgery. ; Secondary Objective: The study has two secondary objectives. The first is to determine how well a computer program called ‘Simcyp Paediatric Simulator’ predicts midazolam metabolism in critically ill children and in otherwise healthy children undergoing surgery. The second is to determine whether blood midazolam level measurements made from microvolume samples of dried blood are equivalent to blood midazolam measurements made using wet blood samples. ;Primary end point(s): The primary outcome measure is determination of midazolam pharmacokinetic (PK) parameters (clearance, volume of distribution and half life) in critically ill children and in otherwise healthy children undergoing surgery. The PK parameters modelled on study data will be used to test whether midazolam pharmacokinetics are significantly different in these two populations.;Timepoint(s) of evaluation of this end point: Evaluation of PK parameters will be done at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (a) Whether measurement of midazolam levels using microvolume samples of dried blood is equivalent to midazolam measurements made using wet blood samples. (b) How well ‘Symcyp Paediatric Simulator’ (SPS) predicts midazolam pharmacokinetic(PK) parameters (clearance, volume of distribution and half life) in critically ill children and in otherwise healthy children undergoing surgery. Symcyp Paediatric Simulator predictions of midazolam PK parameters will be classed on how close they are to PK parameter estimates modelled using study data. Predictions that fall between 0.8 and 1.25 fold of the modelled PK parameters will be classed as very good; predictions that fall between 1.25 and 2 fold will be classed as fair and predictions greater than 2 fold will be classed as poor. ;Timepoint(s) of evaluation of this end point: Evaluation of secondary end points will be done at the end of the trial. | — |
Countries
United Kingdom
Contacts
Public ContactHitesh Pandya
University of Leicester
Outcome results
None listed