Comparison of N2O Inhalation and Ketamine in Pediatric PSA
NCT ID: NCT00834730
Last Updated: 2011-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2009-01-31
2009-12-31
Brief Summary
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* 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
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ketamine
Ketamine 2mg/kg IV
N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
N2O gas
50%-70% N2O gas inhalation
N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
Interventions
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N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* A wound around eye and mouth
36 Months
10 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jin Hee Lee, Professor
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Countries
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References
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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.
Other Identifiers
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N2O
Identifier Type: -
Identifier Source: org_study_id
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