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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
National Institutes of Health (NIH) |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00581139 |
Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
|---|---|
| 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 Name: 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 Name: PPIA Preparation Program
|
| Active Comparator: 4 |
Other: PPIA preparation program PLUS Midazolam premedication
Subjects in this group will receive both interventions 2 and 3.
|
Eligibility| Ages Eligible for Study: | 3 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| Principal Investigator: | Zeev N Kain, MD, MBA | Yale University Department of Anesthesiology |
More Information
| Responsible Party: | Zeev N. Kain, MD, Yale University Department of Anesthesiology |
| ClinicalTrials.gov Identifier: | NCT00581139 History of Changes |
| Other Study ID Numbers: | 9801009972, R01HD37007-01 |
| Study First Received: | December 18, 2007 |
| Last Updated: | October 27, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Anesthetics Midazolam Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
