The Effect of Pediatric Patient Temperament on Postoperative Outcomes

Emergence Delirium Clinical Trial

Official title:

The Effect of Pediatric Patient Temperament on Postoperative Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224324
• Other study ID #: IRB-P00033445
• Status: Recruiting
• Start date: March 10, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2023
• Source: Boston Children's Hospital
• Contact: Stephen Kelleher, MD
• Phone: 617-355-7737
• Email: stephen.kelleher[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 344
• Est. completion date: October 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Delirium
• Temperament

Intervention

Procedure:
• Tonsillectomy and Adeniodectomy
pediatric patients undergoing tonsillectomy and adenoidectomy

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temperament	Patient temperament based on the Children's Behavior Questionnaire. This is a 36 question temperament inventory completed by the caregiver. Items are scored on a scale from 1 to 7, where 1 is "extremely untrue" and 7 is "extremely true". Total scores are linked to temperament constructs of Surgency, Negative Affectivity, and Effortful Control.	preoperative period
Primary	Pain score	Pain behavior to be recorded using numerical rating scale (NRS), FLACC scale or Wong Baker Faces scale as appropriate for age and developmental status. All of these scales are scored from 1-10 where higher scores indicate more pain.	immediately post operative period
Primary	emergence agitation	Measured using the Pediatric Emergence Delirium Scale (PAED). Scored on a scale from 0-4 where total scores of 10 or greater at any time during Post Anesthesia Care Unit (PACU) stay are classified as experiencing agitation.	immediately post operative period
Primary	post hospital behavior changes	Measured using the Post Hospitalization Behavior Questionnaire. Questions are answered on a scale of 1-5, where 1 is less than before and 5 is more than before. Adverse behavioral outcomes to be defined as those patients who experienced behavioral changes at one or more standard deviations above the sample mean.	up to 4 weeks after surgery