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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000668202

Enrollment

Registered

2009-08-06

Start date

2009-10-26

Completion date

2010-03-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 anaesthesia. This will be administered as a single shot caudal.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 18 Years

Healthy volunteers

Yes

Inclusion criteria

Inclusion criteria: 1. Children aged under 18 years. 2. Subumbilical surgery planned. 3. 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 criteria

Exclusion criteria: 1. Caudal analgesia refused by parent/guardian. 2. Allergy to levobupivacaine/drug solution excipients. 3. Administration of levobupivacaine, adrenaline or clonidine via any route in 72 hours prior to, or any extra administration during, the study period.

Outcome results