Trial record 3 of 11 for:    Open Studies | "Adenoidectomy"

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
National Institutes of Health (NIH)
Information provided by:
Yale University Identifier:
First received: December 18, 2007
Last updated: October 27, 2008
Last verified: October 2008
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
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: 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 ] [ Designated as safety issue: No ]

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.


Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Outpatient tonsillectomy or tonsils/adenoids
  • ASA I, II

Exclusion Criteria:

  • Developmental delay
  • Psychotropic medication
  • Meds which interfere with metabolism of midazolam
  • 36 weeks gestation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00581139

Contact: Megan E Weinberg, MA 737-5920
Contact: Kathryn Crofton, BA 785-3190

United States, Connecticut
Yale University Department of Anesthesiology Recruiting
New Haven, Connecticut, United States, 06510
Contact: Megan E Weinberg, MA    203-737-5920   
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
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 Identifier: NCT00581139     History of Changes
Other Study ID Numbers: 9801009972  R01HD037007-01 
Study First Received: December 18, 2007
Last Updated: October 27, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on May 03, 2016