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Comparison of N2O Inhalation and Ketamine in Pediatric PSA (PSA)

Primary Purpose

Moderate Sedation, Laceration

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
N2O gas vs ketamine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Sedation

Eligibility Criteria

36 Months - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric patients with lacerated wound

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ketamine

N2O gas

Arm Description

Ketamine 2mg/kg IV

50%-70% N2O gas inhalation

Outcomes

Primary Outcome Measures

The recovery time (from completion of laceration repair to recovery of mental state)

Secondary Outcome Measures

Sedation scale
pain scale
Side effects
Satisfaction of parents and clinicians

Full Information

First Posted
February 1, 2009
Last Updated
September 13, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00834730
Brief Title
Comparison of N2O Inhalation and Ketamine in Pediatric PSA
Acronym
PSA
Official Title
Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Sedation, Laceration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Active Comparator
Arm Description
Ketamine 2mg/kg IV
Arm Title
N2O gas
Arm Type
Experimental
Arm Description
50%-70% N2O gas inhalation
Intervention Type
Drug
Intervention Name(s)
N2O gas vs ketamine
Intervention Description
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
Primary Outcome Measure Information:
Title
The recovery time (from completion of laceration repair to recovery of mental state)
Time Frame
before discharge
Secondary Outcome Measure Information:
Title
Sedation scale
Time Frame
before discharge
Title
pain scale
Time Frame
before discharge
Title
Side effects
Time Frame
during procedure and bedore discharge and 1day after discharge
Title
Satisfaction of parents and clinicians
Time Frame
before discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric patients with lacerated wound Exclusion Criteria: Contraindication of ketamine or N2O gas A wound around eye and mouth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Hee Lee, Professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23187987
Citation
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.
Results Reference
derived

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Comparison of N2O Inhalation and Ketamine in Pediatric PSA

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