NCT00834730

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

11 months

First QC Date

February 1, 2009

Last Update Submit

September 13, 2011

Conditions

Moderate SedationLaceration

Outcome Measures

Primary Outcomes (1)

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

    before discharge

Secondary Outcomes (4)

  • 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

Study Arms (2)

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

N2O gas vs ketamineDRUG

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

KetamineN2O gas

Eligibility Criteria

Age36 Months - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients with lacerated wound

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 23187987DERIVED

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jin Hee Lee, Professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2009

First Posted

February 3, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations

KR(1)