Impact of topical lignocaine on the incidence of perioperative respiratory complications in children undergoing laryngo-tracheo-bronchoscopies – a double blind randomised controlled pilot study

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000235000

Enrollment

200

Registered

2010-03-22

Start date

2009-11-18

Completion date

2013-09-20

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 purpose of this study is to characterize the modification induced by lignocaine on the incidence of intraoperative and postoperative respiratory complications in children undergoing laryngo tracheo bronchoscopies.

Interventions

Topical lignocaine vs. placebo onto vocal cords for a laryngo-tracheo-bronchoscopy. The lignocaine is applied directly following induction of anaesthesia. It is only applied once which takes one spray of lignocaine of 5-10 seconds duration. The lignocaine dose used will be a maximum of 4 mg/kg as topical spray (under vision) onto the vocal cords. For this trial, lignocaine 4% will be used in all children. In children > 30 kg 3 ml of lignocaine 4% will be applied.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

0 to 16 Years

Healthy volunteers

Inclusion criteria

Children, aged 0 to 16 years, male or female undergoing an laryngo-tracheo-bronchoscopy (LTB).

Exclusion criteria

Hypersensitivity to lignocaine, airway reconstruction surgery

Outcome results