Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02205502

Enrollment

Registered

2014-07-31

Start date

2013-12-31

Completion date

2018-10-31

Last updated

2018-01-09

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

Conditions

Analgesia, Anesthesia, Conscious Sedation Failure During Procedure

Brief summary

Ketamine seems an obvious choice in the setting of an emergency department in laceration repair. Lidocaine is the local anesthetics widespread used. Ketamine leads to dissociative amnesia. Theoretically , lidocaine is not useful in laceration repair using ketamine. However, lidocaine is used with ketamine in many emergency department. The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure

Interventions

DRUGLidocaine

Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.

DRUGNormal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Months to 10 Years

Healthy volunteers

Inclusion criteria

* patients who need suturing for laceration under procedural anesthesia using ketamine

Exclusion criteria

* contraindication to ketamine and lidocaine * patients involved to other studies * more or equal to American Society of Anesthesiologist (ASA) class III * not alert

Design outcomes

Primary

Measure	Time frame	Description
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS	up to 1 hour	The investigators will measure pain scale of sedated children with the CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) during suturing of lacerated wound.

Secondary

Measure	Time frame	Description
Sedation scale	up to 1 hour	The investigators will measure sedation scale with Ramsey Sedation Scale.
Complication	up to 1 hour	The investigators will measure complication with continuous oxygen saturation by pulse oximetry (SpO2) and ECG monitoring and record the monitoring result every 5 minutes.
Satisfaction of parents and clinicians	up to 1 hour	The investigators will measure Drs. and care givers' satisfaction rate using numeric rating scale

Countries

South Korea

Contacts

Primary ContactJin Hee Lee, Professor

gienee@snubh.org+82-31-787-7575

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026