Pharmacokinetics of 0.25% levobupivacaine with adrenaline following caudal epidural administration in childre

Phase 4

• Conditions: Pharmacokinetics in children receiving Levobupivacaine; Other -

• Registration Number: ACTRN12606000428561
• Lead Sponsor: Royal Childrens' Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Children undergoing subumbilical surgery for which caudal analgesia is indicated.

Exclusion Criteria

Allergy to levobupivacaine, refusal, major renal, hepatic or cardiac disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma levobupivacaine levels following single shot caudal epidural anlagesia with levobupivacaine 0.25% and adrenaline 1:200000.[In the six hours following single shot caudal epidural anlagesia with levobupivacaine and adrenaline. Up to three random plasma levobupivacaine levels will be assayed in this time period.]

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of levobupivacaine over six hours following its use in caudal epidural analgesia with Adrenaline 1:200000. Up to three random plasma measurements taken during this six hours will be analysed via NONMEM population pharmacokinetic modelling to give a population plasma concentration versus time profile, volume of distribution and clearance data.[]