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The Effect of Pediatric Patient Temperament on Postoperative Outcomes

The Effect of Pediatric Patient Temperament on Postoperative Outcomes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04224324
Enrollment
344
Registered
2020-01-13
Start date
2020-03-10
Completion date
2024-10-01
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Temperament

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.

Interventions

PROCEDURETonsillectomy and Adeniodectomy

pediatric patients undergoing tonsillectomy and adenoidectomy

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Temperamentpreoperative periodPatient 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 scoreimmediately post operative periodPain 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 agitationimmediately post operative periodMeasured 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 changesup to 4 weeks after surgeryMeasured 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.

Countries

United States

Contacts

Primary ContactStephen Kelleher, MD
stephen.kelleher@childrens.harvard.edu617-355-7737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026