The Effect of Pediatric Patient Temperament on Postoperative Outcomes

NCT04224324 | Unknown

• 1 other identifier: IRB-P00033445
• Study Type: observational
• Target: 344
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

T & A patients

pediatric patients undergoing tonsillectomy and adenoidectomy

Procedure: Tonsillectomy and Adeniodectomy

Interventions

Tonsillectomy and Adeniodectomy PROCEDURE

pediatric patients undergoing tonsillectomy and adenoidectomy

T & A patients

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric patients undergoing tonsillectomy and adenoidectomy at Boston Children's Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Stephen Kelleher, MD

CONTACT

617-355-7737; stephen.kelleher@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: March 10, 2020
• Primary Completion: February 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

US (1)