Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02205502
• Other study ID #: Lidocaine-01
• Status: Recruiting
• Phase: Phase 4
• First received: June 16, 2014
• Last updated: January 6, 2018
• Start date: December 2013
• Est. completion date: October 2018

Study information

• Verified date: January 2018
• Source: Seoul National University Hospital
• Contact: Jin Hee Lee, Professor
• Phone: +82-31-787-7575
• Email: gienee[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Conscious Sedation Failure During Procedure

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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