Not Yet RecruitingPhase 3ACTRN12609000126213

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

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


Sponsor

Royal Children's Hospital

Enrollment

50 participants

Start Date

Jan 12, 2009

Study Type

Interventional

Conditions

Summary

The aim of this study is to determine how clonidine 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 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)

Exclusion Criteria3

  • Caudal analgesia refused by parent/guardian.
  • Allergy to levobupivacaine/drug solution excipients.
  • Administration of levobupivacaine or clonidine via any route in 72 hours prior to, or any extra administration during, the study period.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants will recieve 0.25% levobupivacaine in a volume to be determined by the attending anaesthetist with clonidine 2mcg/mL, via the caudal route, under general anaesthesia

Participants will recieve 0.25% levobupivacaine in a volume to be determined by the attending anaesthetist with clonidine 2mcg/mL, via the caudal route, under general anaesthesia


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12609000126213