The Effect of Pediatric Patient Temperament on Postoperative Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Pediatric Patient Temperament on Postoperative Outcomes

Conditions
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Emergence Delirium, Temperament

Intervention / Treatment
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* Procedure: Tonsillectomy and Adeniodectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T & A patients<br>pediatric patients undergoing tonsillectomy and adenoidectomy | Procedure: Tonsillectomy and Adeniodectomy<br>* pediatric patients undergoing tonsillectomy and adenoidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |