Study of local anaesthetic blood levels during airway examination in children

Observational study of lidocaine levels in children after airway topicalisation during direct laryngotracheobronchosopy (DLTB). - Lidocaine levels In DLTBs Study (LID Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005207-25-GB

Enrollment

Registered

2015-12-09

Start date

2016-03-03

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Children requiring airway examination under anaesthesia MedDRA version: 20.0 Level: PT Classification code 10024758 Term: Local anaesthesia System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Lidocaine Hydrochloride Injection BP 2% w/v Product Name: Lidocaine Hydrochloride Injection BP 2% w/v, clear, colourless sterile injection Pharmaceutical Fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All children 0 to 8 years undergoing elective diagnostic or therapeutic DLTB, whose parents/guardians consent for inclusion in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Pre-op exposure to lidocaine (e.g. EMLA) Inability to insert a second iv cannula for sampling; no more than 3 sites to be attempted

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify the peak blood levels of lidocaine in children undergoing an endoscopic examination of their airways under anaesthesia. The local anaesthetic lidocaine, is routinely applied to the airway during this procedure as part of the anaesthetic technique. ;Secondary Objective: To determine the time taken for the peak levels of lidocaine to occur after drug administration. To determine any adverse events during these procedures.;Primary end point(s): Plasma peak concentration of lidocaine during DLTB; Timepoint(s) of evaluation of this end point: Initial 1ml venous blood sample to be taken at 5 min post lidocaine application. Further samples 1ml samples o be taken at 10, 15 and 20 min.	—

Measure

Time frame

Main Objective: To identify the peak blood levels of lidocaine in children undergoing an endoscopic examination of their airways under anaesthesia. The local anaesthetic lidocaine, is routinely applied to the airway during this procedure as part of the anaesthetic technique. ;Secondary Objective: To determine the time taken for the peak levels of lidocaine to occur after drug administration. To determine any adverse events during these procedures.;Primary end point(s): Plasma peak concentration of lidocaine during DLTB; Timepoint(s) of evaluation of this end point: Initial 1ml venous blood sample to be taken at 5 min post lidocaine application. Further samples 1ml samples o be taken at 10, 15 and 20 min.

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Secondary

Measure	Time frame
Secondary end point(s): Time to peak plasma levels Signs of lidocaine toxicity (restricted to ECG changes or seizures when under anaesthesia) Episodes of laryngospasm, coughing, desaturation during the procedure ;Timepoint(s) of evaluation of this end point: Duration of procedure	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026