Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

Ketamine

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

Intervention / Treatment

  • Lidocaine (DRUG)
    Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.
  • Normal saline (DRUG)
    N/A

Condition or Disease

  • Conscious Sedation Failure During Procedure
  • Analgesia
  • Anesthesia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 12 Months to 10 Years
    Enrollment: 58 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Dec 01, 2013
    Primary Completion: Oct 01, 2018 ESTIMATED
    Completion Date: Oct 01, 2018 ESTIMATED
    Study First Posted: Jul 31, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 06, 2018

    Sponsors / Collaborators

    Lead Sponsor: Seoul National University Hospital
    Responsible Party: N/A

    Location

    South Korea
    Gyeong-gi Do, South Korea

    Participant Groups

    • Proper amount of lidocaine will be injected lacerated wound. * dosage form: fluid * dosage: not exceeding 1mg/kg * frequency: once * duration: n/a

    • Normal saline will be used as a placebo for lidocaine

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 10
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 Outcomes

    • The investigators will measure sedation scale with Ramsey Sedation Scale.

    • The investigators will measure complication with continuous oxygen saturation by pulse oximetry (SpO2) and ECG monitoring and record the monitoring result every 5 minutes.

    • The investigators will measure Drs. and care givers' satisfaction rate using numeric rating scale

    More Details

    NCT Number: NCT02205502
    Other IDs: Lidocaine-01
    Study URL: https://clinicaltrials.gov/study/NCT02205502
    Last updated: Sep 29, 2023