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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00834730

Acronym

PSA

Enrollment

Registered

2009-02-03

Start date

2009-01-31

Completion date

2009-12-31

Last updated

2011-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laceration, Moderate Sedation

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

Interventions

DRUGN2O gas vs ketamine

Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

36 Months to 10 Years

Healthy volunteers

Inclusion criteria

* Pediatric patients with lacerated wound

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026