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NIH: Psychological Influences on Postoperative Recovery

Sponsor
Yale University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00581139
Collaborator
National Institutes of Health (NIH) (NIH)
377
Enrollment
1
Location
4
Arms
72
Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Preoperative Preparation Program (Child Life Specialist)
  • Drug: Midazolam
  • Behavioral: Parental Presence during Induction of Anesthesia
  • Other: PPIA preparation program PLUS Midazolam premedication
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
377 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Psychological Influences on Postoperative Recovery
Study Start Date :
Apr 1, 2003
Anticipated Primary Completion Date :
Apr 1, 2009
Anticipated Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Behavioral: Preoperative Preparation Program (Child Life Specialist)
This group will receive the standard preoperative visit to the hospital with Child Life intervention
Active Comparator: 2

Drug: Midazolam
0.5 mg/kg oral midazolam
Other Names:
  • Versed

    		•
    Active Comparator: 3

    Behavioral: 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.
    Other Names:
  • PPIA Preparation Program

    		•
    Active Comparator: 4

    Other: PPIA preparation program PLUS Midazolam premedication
    Subjects in this group will receive both interventions 2 and 3.

    Outcome Measures

    Primary Outcome Measures

    1. Improved perioperative outcomes [postop days 1-5, 1 wk, 2 wk, 3mo, 6mo]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Outpatient tonsillectomy or tonsils/adenoids

    • ASA I, II

    Exclusion Criteria:

    • Developmental delay

    • ASA III-IV

    • Psychotropic medication

    • Meds which interfere with metabolism of midazolam

    • 36 weeks gestation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale University Department of Anesthesiology New Haven Connecticut United States 06510

    Sponsors and Collaborators

    • Yale University
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Zeev N Kain, MD, MBA, Yale University Department of Anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00581139
    Other Study ID Numbers:
    • 9801009972
    • R01HD037007-01
    First Posted:
    Dec 27, 2007
    Last Update Posted:
    Oct 28, 2008
    Last Verified:
    Oct 1, 2008
    Additional relevant MeSH terms:
    Pain, Postoperative
    Midazolam

    Study Results

    No Results Posted as of Oct 28, 2008