Comparison of N2O Inhalation and Ketamine in Pediatric PSA | NCT00834730

Studies
Comparison of N2O Inhalation and Ketamine in Pediatric PSA

NCT00834730

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Sep 15, 2011Estimated

Enrollment

32Actual

Phase

Phase 4

Conditions

Moderate Sedation
Laceration

Interventions

N2O gas vs ketamine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Feb 1, 2009

First Submission Date that Met QC Criteria

Feb 1, 2009

First Posted Date

Feb 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2011

Last Update Posted Date

Sep 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketamine	Active Comparator	Ketamine 2mg/kg IV	Drug: N2O gas vs ketamine
N2O gas	Experimental	50%-70% N2O gas inhalation	Drug: N2O gas vs ketamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N2O gas vs ketamine	Drug	Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas	Ketamine N2O gas

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Sedation scale		before discharge
pain scale		before discharge
Side effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients with lacerated wound

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

36 Months

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin Hee Lee, Professor	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Gyeonggi-do		463-707	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23187987	Derived	Lee JH, Kim K, Kim TY, Jo YH, Kim SH, Rhee JE, Heo CY, Eun SC. A randomized comparison of nitrous oxide versus intravenous ketamine for laceration repair in children. Pediatr Emerg Care. 2012 Dec;28(12):1297-301. doi: 10.1097/PEC.0b013e3182768a86.