CompletedPhase 3ACTRN12609000845235

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

A non-randomised single group study on the pharmokinetics of 0.25% levobupivacaine with adrenaline administered caudally in children undergoing elective sub-umbilical surgical procedures for which caudal epidural analgesia is indicated


Sponsor

Royal Children's Hospital

Enrollment

60 participants

Start Date

Dec 8, 2009

Study Type

Interventional

Conditions

Summary

The aim of this study is to determine how adrenaline affects the absorption of levobupivacaine in children having caudal anaesthesia for sub-umbilical surgery. Our study hypothesis is that the absorption of levobupivacaine will be affected when administered in conjunction with adrenaline via the caudal route.


Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 18 Yearss

Inclusion Criteria3

  • Children aged under 18 years.
  • Subumbilical surgery planned.
  • Caudal analgesia with levobupivacaine and adrenaline regarded as acceptable standard of care by treating anaesthetist (or by independent anaesthetist where conflict of interest arises between research and treating anaesthetist)

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Interventions

Participants will receive 0.25% levobupivacaine in a volume to be determined by the attending anaesthetist with adrenaline 5 mcg/mL via the caudal route, under general anaesthesia. This will be admini

Participants will receive 0.25% levobupivacaine in a volume to be determined by the attending anaesthetist with adrenaline 5 mcg/mL via the caudal route, under general anaesthesia. This will be administered as a single shot caudal.


Locations(1)

Australia

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ACTRN12609000845235