Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT04224324

Conditions

Emergence Delirium

Temperament

Eligibility Criteria

Sex: All

Age: 2 - 7

Healthy Volunteers: Not accepted

Interventions

Tonsillectomy and Adeniodectomy

Study Details

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.

Conditions

Emergence Delirium

Temperament

Study ID

NCT04224324

Start date

Mar 10, 2020

Status verified date

Mar, 2023

Completion date

Oct 1, 2024

Anticipated

Primary completion date

Feb 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 7

Healthy Volunteers: Not accepted

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

Enrollment

344 participants

Anticipated

Interventions and Outcome Measures

Arms

T & A patients

pediatric patients undergoing tonsillectomy and adenoidectomy

Interventions

Tonsillectomy and Adeniodectomy

pediatric patients undergoing tonsillectomy and adenoidectomy

Primary outcome measure

  • Temperament [ Time Frame: preoperative period ]
  • Pain score [ Time Frame: immediately post operative period ]
  • emergence agitation [ Time Frame: immediately post operative period ]
  • post hospital behavior changes [ Time Frame: up to 4 weeks after surgery ]

Central Contacts and Locations

Central contacts

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Stephen Kelleher, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 30, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2023-03-30.