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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04224324
Other study ID # IRB-P00033445
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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