Comparison of N2O Inhalation and Ketamine in Pediatric PSA — PSA  

Laceration Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laceration
• Lacerations
• Moderate Sedation

• NCT number: NCT00834730
• Study type: Interventional
• Source: Seoul National University Hospital
• Status: Completed
• Phase: Phase 4
• Start date: January 2009
• Completion date: December 2009