Pharmacokinetics of ketamine in infants - Pharmacokinetics of ketamine in infants. Version 3

Phase 1

• Conditions: Pharmacokinetics of ketamine in infants; MedDRA version: 9.1 Level: LLT Classification code 10021723 Term: Induction and maintenance of anaesthesia

• Registration Number: EUCTR2008-003293-18-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-22
• Study Completion: 2012-05-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

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

(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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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