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Sponsors and Collaborators: |
Yale University National Institutes of Health (NIH) |
Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00581139 |
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 | Intervention | Phase |
Care, Postoperative Pain, Postoperative Surgical Procedures, Operative Otorhinolaryngologic Surgical Procedures Tonsillectomy Adenoidectomy |
Behavioral: Preoperative Preparation Program (Child Life Specialist) Drug: Midazolam Behavioral: Parental Presence during Induction of Anesthesia Other: PPIA preparation program PLUS Midazolam premedication |
Phase II |
MedlinePlus related topics: | Anesthesia Tonsils and Adenoids |
ChemIDplus related topics: | Midazolam Midazolam hydrochloride Midazolam maleate |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Factorial Assignment |
Official Title: | Psychological Influences on Postoperative Recovery |
Estimated Enrollment: | 377 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator |
Behavioral: Preoperative Preparation Program (Child Life Specialist)
This group will receive the standard preoperative visit to the hospital with Child Life intervention
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2: Active Comparator |
Drug: Midazolam
0.5 mg/kg oral midazolam
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3: Active Comparator |
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.
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4: Active Comparator |
Other: PPIA preparation program PLUS Midazolam premedication
Subjects in this group will receive both interventions 2 and 3.
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Ages Eligible for Study: | 3 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Megan E Weinberg, MA | 737-5920 | megan.weinberg@yale.edu |
Contact: Kathryn Crofton, BA | 785-3190 | kathryn.crofton@yale.edu |
United States, Connecticut | |||||
Yale University Department of Anesthesiology | Recruiting | ||||
New Haven, Connecticut, United States, 06510 | |||||
Contact: Megan E Weinberg, MA 203-737-5920 megan.weinberg@yale.edu |
Yale University |
National Institutes of Health (NIH) |
Principal Investigator: | Zeev N Kain, MD, MBA | Yale University Department of Anesthesiology |
Responsible Party: | Yale University Department of Anesthesiology ( Zeev N. Kain, MD ) |
Study ID Numbers: | 9801009972, R01HD37007-01 |
First Received: | December 18, 2007 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00581139 |
Health Authority: | United States: Institutional Review Board |
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