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:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00581139
First received: December 18, 2007
Last updated: October 27, 2008
Last verified: October 2008
  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: 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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Zeev N Kain, MD, MBA Yale University Department of Anesthesiology
  More Information

No publications provided

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

Additional relevant MeSH terms:
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
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

ClinicalTrials.gov processed this record on August 18, 2014