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

September 13, 2011 updated by: Seoul National University Hospital

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

  • 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patients with lacerated wound

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ketamine
Ketamine 2mg/kg IV
Drug: N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
Experimental: N2O gas
50%-70% N2O gas inhalation
Drug: N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Satisfaction of parents and clinicians
Time Frame: before discharge
before discharge
Sedation scale
Time Frame: before discharge
before discharge
pain scale
Time Frame: before discharge
before discharge
Side effects
Time Frame: during procedure and bedore discharge and 1day after discharge
during procedure and bedore discharge and 1day after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 1, 2009

First Submitted That Met QC Criteria

February 1, 2009

First Posted (Estimate)

February 3, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2011

Last Update Submitted That Met QC Criteria

September 13, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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