Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

Phase 4

• Conditions: Conscious Sedation Failure During Procedure; Analgesia; Anesthesia
• Interventions: Drug: Normal saline; Drug: Lidocaine

• Registration Number: NCT02205502
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-06
• Last Update Posted: 2018-01-09
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	Normal saline will be used as a placebo for lidocaine
Lidocaine	Lidocaine	Proper amount of lidocaine will be injected lacerated wound. * dosage form: fluid * dosage: not exceeding 1mg/kg * frequency: once * duration: n/a

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of