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Comparison of N2O Inhalation and Ketamine in Pediatric PSA (PSA)

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ClinicalTrials.gov Identifier: NCT00834730
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : September 15, 2011
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE February 1, 2009
First Posted Date  ICMJE February 3, 2009
Last Update Posted Date September 15, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2009)
The recovery time (from completion of laceration repair to recovery of mental state) [ Time Frame: before discharge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2009)
  • Sedation scale [ Time Frame: before discharge ]
  • pain scale [ Time Frame: before discharge ]
  • Side effects [ Time Frame: during procedure and bedore discharge and 1day after discharge ]
  • Satisfaction of parents and clinicians [ Time Frame: before discharge ]
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 Comparison of N2O Inhalation and Ketamine in Pediatric PSA
Official Title  ICMJE Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.
Brief Summary
  • Ketamine provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients
  • However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies
  • We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and anxiolysis during primary repair of lacerated pediatric patients
Detailed Description
  • There were 32 children who were randomly assigned
  • Recovery times were markedly shorter in the N2O group compared with those in the ketamine group (median, 0.0 min (interquartile range [IQR], 0.0-4.0 min) vs. median, 21.5 min (IQR, 12.5-37.5 min), N2O vs. ketamine, respectively, p < 0.05)
  • Sedation levels were deeper in the ketamine group than in the N2O group, but pain scales were comparable between groups
  • No difference was observed in the satisfaction scores by physicians, parents, or nurses.
  • N2O inhalation was preferable to injectable ketamine for pediatric patients because it is safe, allows for a faster recovery, maintains sufficient sedation time, and does not induce unnecessarily deep sedation
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Moderate Sedation
  • Laceration
Intervention  ICMJE Drug: N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Ketamine 2mg/kg IV
    Intervention: Drug: N2O gas vs ketamine
  • Experimental: N2O gas
    50%-70% N2O gas inhalation
    Intervention: Drug: N2O gas vs ketamine
Publications * Lee JH, Kim K, Kim TY, Jo YH, Kim SH, Rhee JE, Heo CY, Eun SC. A randomized comparison of nitrous oxide versus intravenous ketamine for laceration repair in children. Pediatr Emerg Care. 2012 Dec;28(12):1297-301. doi: 10.1097/PEC.0b013e3182768a86.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2011)
32
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2009)
72
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pediatric patients with lacerated wound

Exclusion Criteria:

  • Contraindication of ketamine or N2O gas
  • A wound around eye and mouth
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 36 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 NCT00834730
Other Study ID Numbers  ICMJE N2O
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 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
PRS Account Seoul National University Hospital
Verification Date September 2011

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