The Effect of Pediatric Patient Temperament on Postoperative Outcomes

Recruiting

• Conditions: Temperament; Emergence Delirium
• Interventions: Procedure: Tonsillectomy and Adeniodectomy

• Registration Number: NCT04224324
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Study Start: 2020-03-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30
• Primary Completion: 2024-02-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 344

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T & A patients	Tonsillectomy and Adeniodectomy	pediatric patients undergoing tonsillectomy and adenoidectomy

Primary Outcome Measures

Name	Time	Method
Temperament	preoperative period	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.
Pain score	immediately post operative period	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.
emergence agitation	immediately post operative period	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.
post hospital behavior changes	up to 4 weeks after surgery	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States