NCT00834730

Comparison of N2O Inhalation and Ketamine in Pediatric PSA

Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 36 Months – 10 Years
• Healthy volunteers: Not accepted

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

Conditions

• Moderate Sedation
• Laceration

Interventions

Type	Name	Description
DRUG	N2O gas vs ketamine	Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-02-03
• Last updated: 2011-09-15

Locations

1 site across 1 country: South Korea