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Psychological Influences on Postoperative Recovery (NIH)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Yale University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581139
First Posted: December 27, 2007
Last Update Posted: October 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Yale University
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Psychological Influences on Postoperative Recovery

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Improved perioperative outcomes [ Time Frame: postop days 1-5, 1 wk, 2 wk, 3mo, 6mo ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581139


Contacts
Contact: Megan E Weinberg, MA 737-5920 megan.weinberg@yale.edu
Contact: Kathryn Crofton, BA 785-3190 kathryn.crofton@yale.edu

Locations
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   
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Investigators
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
R01HD037007-01 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2007
First Posted: December 27, 2007
Last Update Posted: October 28, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Midazolam
Central Nervous System Depressants
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action