Pharmacokinetics of ketamine in infants MedDRA version: 9.1 Level: LLT Classification code 10021723 Term: Induction and maintenance of anaesthesia
Conditions
Interventions
Trade Name: Ketalar (TM)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: KETAMINE HYDROCHLORIDE
CAS Number: 1867669
Con
Sponsors
Belfast Health and Social Care Trust
Queen's University Belfast
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Clinicians have identified an infant who requires a procedure requiring sedation. (2) The clinicians have decided it is clinically appropriate to pursue a sedation procedure using ketamine. (3) The infant is less than 6 months old (post-natal age). Are the trial subjects under 18? yes Number of subjects for this age range: 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: (1) Ketamine is contraindicated for the patient, as per the Summary of Product Characteristics (SmPC), section 4.3. (2) The clinician’s plan to depart from sedation using ketamine. (3) The patient has participated in this study on a previous occasion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To apply this modelling to help optimise the dosing regimen in infants.;Primary end point(s): Population pharmacokinetic model for ketamine in infants;Main Objective: To define the pharmacokinetic parameters of ketamine and its metabolites in infants and to determine the factors which lead to inter- and intra-patient variability | — |
Countries
United Kingdom
Outcome results
None listed