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Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

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ClinicalTrials.gov Identifier: NCT02205502
Recruitment Status : Unknown
Verified January 2018 by Jin Hee Lee, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : July 31, 2014
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Hee Lee, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE June 16, 2014
First Posted Date  ICMJE July 31, 2014
Last Update Posted Date January 9, 2018
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine as Local Anesthetics in Children Under Ketamine Sedation
Official Title  ICMJE Efficacy of Lidocaine as Local Anesthetics in Children Under Procedural Sedation and Analgesia Using 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Conscious Sedation Failure During Procedure
  • Analgesia
  • Anesthesia
Intervention  ICMJE
  • Drug: Lidocaine
    Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.
  • Drug: Normal saline
Study Arms  ICMJE
  • Experimental: Lidocaine

    Proper amount of lidocaine will be injected lacerated wound.

    • dosage form: fluid
    • dosage: not exceeding 1mg/kg
    • frequency: once
    • duration: n/a
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Normal saline
    Normal saline will be used as a placebo for lidocaine
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 29, 2014)
58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02205502
Other Study ID Numbers  ICMJE Lidocaine-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin Hee Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin Hee Lee, Professor Seoul National University Bundang Hospital
Principal Investigator: Jin Hee Lee,, Professor Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP