Emergence DeliriumNCT04224324
The Effect of Pediatric Patient Temperament on Postoperative Outcomes
An observational study of Emergence Delirium and Temperament, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Emergence Delirium, Temperament
- What is being tested?
- Tonsillectomy and Adeniodectomy
- Type of treatment
- Surgery or procedure
- How many people
- 344 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: pediatric patients undergoing tonsillectomy and adenoidectomy at Boston Children's Hospital
Who may be able to join
- ASA I or II
- undergoing Tonsil and/or Adenoid Removal at Boston Children's Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Stephen Kelleher, MD, 617-355-7737, stephen.kelleher@childrens.harvard.edu
Stephen Kelleher, MD
About this study
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
- Being tested
- Tonsillectomy and Adeniodectomy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonsillectomy and AdeniodectomyProcedure or surgery
pediatric patients undergoing tonsillectomy and adenoidectomy
| Study group | Role | What they receive |
|---|---|---|
| T & A patients | pediatric patients undergoing tonsillectomy and adenoidectomy Receives: Procedure: Tonsillectomy and Adeniodectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start10 Mar 2020
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Kelleher, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224324
- Sponsor's protocol ID
- IRB-P00033445
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pediatric Patient Temperament on Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT04224324
- Acronym / sponsor ID
- IRB-P00033445
- Conditions
- Emergence Delirium, Temperament
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T & A patients | – | Procedure: Tonsillectomy and Adeniodectomypediatric patients undergoing tonsillectomy and adenoidectomy |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric patients undergoing tonsillectomy and adenoidectomy at Boston Children's Hospital
Key inclusion criteria (2 listed)
- ASA I or II
- undergoing Tonsil and/or Adenoid Removal at Boston Children's Hospital
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tonsillectomy and Adeniodectomypediatric patients undergoing tonsillectomy and adenoidectomy | Procedure or surgery | T & A patients |
Primary outcome
Temperament
Time frame: preoperative period
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.
Pain score
Time frame: immediately post operative period
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.
emergence agitation
Time frame: immediately post operative period
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.
post hospital behavior changes
Time frame: up to 4 weeks after surgery
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium and Temperament, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Kelleher, MD (617-355-7737, stephen.kelleher@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperament (time frame: preoperative period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.