NCT00834470

Brief Summary

  • Ketamine seems an obvious choice in the setting of an emergency department
  • Ketamine leads to increased production of salivary and tracheal secretions
  • Antisialagogues(atropine)therefore have been recommended as a routine adjunct
  • We compare atropine with placebo as an adjunct to ketamine sedation in children undergoing primary closure of lacerated wound

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2008

Typical duration 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

August 1, 2008

Completed
6 months 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
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 6, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

February 1, 2009

Last Update Submit

August 3, 2012

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (1)

  • Hypersalivation(VAS)

    During procedure

Secondary Outcomes (4)

  • Sedation scale

    before, during procedure, before discharge

  • Pain scale

    before, during procedure, before discharge

  • Complication

    during procedure and bedore discharge and 1day after discharge

  • Satisfaction of parents and clinicians

    before discharge

Study Arms (2)

Atropine

EXPERIMENTAL

Atropine 0.01mg/kg IV

Drug: Atropine

Normal saline

PLACEBO COMPARATOR

Same volume of atropine

Drug: Atropine

Interventions

AtropineDRUG

Ketamine 2mg/kg IV + Atropine 0.01mg/kg or Same volume of Normal saline

AtropineNormal saline

Eligibility Criteria

Age12 Months - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric lacerated patients

You may not qualify if:

  • Contraindication of ketamine or atropine

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)

  • Kye YC, Rhee JE, Kim K, Kim T, Jo YH, Jeong JH, Lee JH. Clinical effects of adjunctive atropine during ketamine sedation in pediatric emergency patients. Am J Emerg Med. 2012 Nov;30(9):1981-5. doi: 10.1016/j.ajem.2012.04.030. Epub 2012 Jun 28.

    PMID: 22748697DERIVED

MeSH Terms

Interventions

Atropine

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Jin Hee Lee, Professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 1, 2009

First Posted

February 3, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 6, 2012

Record last verified: 2012-08

Locations

KR(1)