Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

Overview

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

Full Title of Study: “Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using Ketamine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2018

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Sedation scale
    • Time Frame: up to 1 hour
    • The investigators will measure sedation scale with Ramsey Sedation Scale.
  • 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.
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin Hee Lee, Assistant Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jin Hee Lee, Professor, Principal Investigator, Seoul National University Bundang Hospital
    • Jin Hee Lee,, Professor, Principal Investigator, Seoul National University Bundang Hospital
  • Overall Contact(s)
    • Jin Hee Lee, Professor, +82-31-787-7575, gienee@snubh.org

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