CompletedPhase 3ACTRN12609000668202

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

A non-randomised single group study on the pharmokinetics of 0.25% levobupivacaine with adrenaline and clonidine 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

Oct 26, 2009

Study Type

Interventional

Conditions

Summary

The aim of this study is to determine how adrenaline and clonidine affect 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 and clonidine 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 clonidine 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 and clonidine 2mcg/mL, via the caudal route, under general anaesthes

Participants will receive 0.25% levobupivacaine in a volume to be determined by the attending anaesthetist with adrenaline 5 mcg/mL and clonidine 2mcg/mL, via the caudal route, under general anaesthesia. This will be administered as a single shot caudal.


Locations(1)

Australia

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ACTRN12609000668202