Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

January 6, 2018 updated by: Jin Hee Lee, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lidocaine

Proper amount of lidocaine will be injected lacerated wound.

  • dosage form: fluid
  • dosage: not exceeding 1mg/kg
  • frequency: once
  • duration: n/a
Drug: Lidocaine
Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.
PLACEBO_COMPARATOR: Normal saline
Normal saline will be used as a placebo for lidocaine
Drug: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS
Time Frame: 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.
up to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation scale
Time Frame: up to 1 hour
The investigators will measure sedation scale with Ramsey Sedation Scale.
up to 1 hour
Complication
Time Frame: 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.
up to 1 hour
Satisfaction of parents and clinicians
Time Frame: up to 1 hour
The investigators will measure Drs. and care givers' satisfaction rate using numeric rating scale
up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin Hee Lee,, Professor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

October 1, 2018

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (ESTIMATE)

July 31, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 6, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lidocaine-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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