Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
241 participants
INTERVENTIONAL
2003-04-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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1
Preoperative Preparation Program (Child Life Specialist)
This group will receive the standard preoperative visit to the hospital with Child Life intervention
2
Midazolam
0.5 mg/kg oral midazolam
3
Parental Presence during Induction of Anesthesia
One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.
4
PPIA preparation program PLUS Midazolam premedication
Subjects in this group will receive both interventions 2 and 3.
Interventions
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Preoperative Preparation Program (Child Life Specialist)
This group will receive the standard preoperative visit to the hospital with Child Life intervention
Midazolam
0.5 mg/kg oral midazolam
Parental Presence during Induction of Anesthesia
One parent will be present during induction of anesthesia of the child. The parent will be accompanied out of the OR by a nurse once the induction is completed. These parents will have completed a parent preparation program.
PPIA preparation program PLUS Midazolam premedication
Subjects in this group will receive both interventions 2 and 3.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I, II
Exclusion Criteria
* ASA III-IV
* Psychotropic medication
* Meds which interfere with metabolism of midazolam
* 36 weeks gestation
3 Years
12 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of California, Irvine
OTHER
Responsible Party
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Zeev Kain
Professor
Principal Investigators
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Zeev N Kain, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Yale University Department of Anesthesiology
Locations
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Yale University Department of Anesthesiology
New Haven, Connecticut, United States
Countries
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Other Identifiers
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9801009972 [2008-6723]
Identifier Type: -
Identifier Source: org_study_id
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