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Psychological Influences on Postoperative Recovery (NIH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00581139
First received: December 18, 2007
Last updated: October 27, 2008
Last verified: October 2008
History of Changes

December 18, 2007
October 27, 2008
April 2003
April 2009   (final data collection date for primary outcome measure)
Improved perioperative outcomes [ Time Frame: postop days 1-5, 1 wk, 2 wk, 3mo, 6mo ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581139 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Psychological Influences on Postoperative Recovery
Psychological Influences on Postoperative Recovery

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Care, Postoperative
  • Pain, Postoperative
  • Surgical Procedures, Operative
  • Otorhinolaryngologic Surgical Procedures
  • Tonsillectomy
  • Adenoidectomy
  • Behavioral: Preoperative Preparation Program (Child Life Specialist)
    This group will receive the standard preoperative visit to the hospital with Child Life intervention
  • Drug: Midazolam
    0.5 mg/kg oral midazolam
    Other Name: Versed
  • 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 Name: PPIA Preparation Program
  • Other: PPIA preparation program PLUS Midazolam premedication
    Subjects in this group will receive both interventions 2 and 3.
  • Active Comparator: 1
    Intervention: Behavioral: Preoperative Preparation Program (Child Life Specialist)
  • Active Comparator: 2
    Intervention: Drug: Midazolam
  • Active Comparator: 3
    Intervention: Behavioral: Parental Presence during Induction of Anesthesia
  • Active Comparator: 4
    Intervention: Other: PPIA preparation program PLUS Midazolam premedication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
377
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
3 Years to 12 Years
No
Contact: Megan E Weinberg, MA 737-5920 megan.weinberg@yale.edu
Contact: Kathryn Crofton, BA 785-3190 kathryn.crofton@yale.edu
United States
 
NCT00581139
9801009972, R01HD37007-01
Yes
Zeev N. Kain, MD, Yale University Department of Anesthesiology
Yale University
National Institutes of Health (NIH)
Principal Investigator: Zeev N Kain, MD, MBA Yale University Department of Anesthesiology
Yale University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP