Yale School of Medicine

Research Studies at Yale

Research Studies at Yale

Psychological Influences on Postoperative Recovery

For Patients For Researchers

Conditions: Adenoidectomy; Care, Postoperative; Otorhinolaryngologic Surgical Procedures; Pain, Postoperative; Surgical Procedures, Operative; Tonsillectomy

What is the purpose of this trial?

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.


Dates: April 2003 -
Study Status: Recruiting

Who can participate?

Ages Eligible: 3 Years - 12 Years
Gender Eligible: Both

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

Sponsors: National Institutes of Health (NIH), Yale University
Phase: Phase 2

First Received: December 18, 2007 
Last Updated: Jan 28, 2009
Clinicaltrials.gov ID: NCT00581139
Study HIC # 09801009972

Conditions: Adenoidectomy; Care, Postoperative; Otorhinolaryngologic Surgical Procedures; Pain, Postoperative; Surgical Procedures, Operative; Tonsillectomy

Interventions: Behavioral: Preoperative Preparation Program (Child Life Specialist);
Drug: Midazolam;
Behavioral: Parental Presence during Induction of Anesthesia;
Other: PPIA preparation program PLUS Midazolam premedication

What is the purpose of this trial?

The primary hypothesis tested in this project is that the preoperative behavioral stress response predicts postoperative behavioral and clinical recovery of children undergoing surgery.


Dates: April 2003 -
Study Status: Recruiting

Who can participate?

Ages Eligible: 3 Years - 12 Years
Gender Eligible: Both

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

Sponsors: National Institutes of Health (NIH), Yale University
Phase: Phase 2

First Received: December 18, 2007 
Last Updated: Jan 28, 2009
Clinicaltrials.gov ID: NCT00581139
Study HIC # 09801009972

Participate in this trial

For more information about this trial, contact:

Kathryn Crofton, BA
785-3190
kathryn.crofton@yale.edu

Megan E Weinberg, MA
203-737-5920
megan.weinberg@yale.edu


Yale Researcher

Kain, Zeev
Principal Investigator  

HIC # 0805003779