The Effect of Pediatric Patient Temperament on Postoperative Outcomes

NCT ID: NCT04224324

Last Updated: 2023-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2024-10-01

Brief Summary

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The goal of this study is to determine if preoperative temperament is associated with postoperative pain, emergence agitation, emotional and behavioral changes, and overall parent satisfaction. This is a prospective observational study to assess preoperative temperament in pediatric patients undergoing tonsillectomy and adenoidectomy, gather demographic data, intraoperative data regarding surgical and anesthetic technique, and collect immediate postoperative data to assess pain, emergence agitation (EA), parental satisfaction as well as remote postoperative data to assess emotional and behavior changes. These data will be used to determine if patients with a specific temperament profile are more likely to experience increased pain, emergence agitation, emotional changes, and behavioral disturbances postoperatively.

Detailed Description

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Conditions

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Emergence Delirium Temperament

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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T & A patients

pediatric patients undergoing tonsillectomy and adenoidectomy

Tonsillectomy and Adeniodectomy

Intervention Type PROCEDURE

pediatric patients undergoing tonsillectomy and adenoidectomy

Interventions

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Tonsillectomy and Adeniodectomy

pediatric patients undergoing tonsillectomy and adenoidectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA I or II
* undergoing Tonsil and/or Adenoid Removal at Boston Children's Hospital

Exclusion Criteria

* history of prematurity
* major chronic medical conditions
* neurological impairment or developmental delay
* parents/guardians who do not speak English or are unable to understand the questionnaires
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stephen Kelleher

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stephen Kelleher, MD

Role: CONTACT

617-355-7737

Facility Contacts

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Stephen Kelleher, MD

Role: primary

617-355-7737

Other Identifiers

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IRB-P00033445

Identifier Type: -

Identifier Source: org_study_id

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