Comparison of N2O Inhalation and Ketamine in Pediatric PSA

Phase 4

Completed

• Conditions: Moderate Sedation; Laceration
• Interventions: Drug: N2O gas vs ketamine

• Registration Number: NCT00834730
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-01
• Study First Submitted QC: 2009-02-01
• Study First Posted: 2009-02-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-13
• Last Update Posted: 2011-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Pediatric patients with lacerated wound

Exclusion Criteria

• Contraindication of ketamine or N2O gas
• A wound around eye and mouth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	N2O gas vs ketamine	Ketamine 2mg/kg IV
N2O gas	N2O gas vs ketamine	50%-70% N2O gas inhalation

Primary Outcome Measures

Name	Time	Method
The recovery time (from completion of laceration repair to recovery of mental state)	before discharge

Secondary Outcome Measures

Name	Time	Method
Sedation scale	before discharge
pain scale	before discharge
Side effects	during procedure and bedore discharge and 1day after discharge
Satisfaction of parents and clinicians	before discharge

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of