Comparison of N2O Inhalation and Ketamine in Pediatric PSA

Laceration Clinical Trial

— PSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834730
• Other study ID #: N2O
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2009
• Last updated: September 13, 2011
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: September 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Months to 10 Years

Eligibility

Inclusion Criteria:

• Pediatric patients with lacerated wound

Exclusion Criteria:

• Contraindication of ketamine or N2O gas

• A wound around eye and mouth

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

Intervention

Drug:
• N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recovery time (from completion of laceration repair to recovery of mental state)		before discharge	Yes
Secondary	Sedation scale		before discharge	Yes
Secondary	pain scale		before discharge	Yes
Secondary	Side effects		during procedure and bedore discharge and 1day after discharge	Yes
Secondary	Satisfaction of parents and clinicians		before discharge	Yes