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Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I

Primary Purpose

Post Concussion Symptoms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Concussion Questionnaire
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Post Concussion Symptoms

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients aged 5-21 years of age presenting for repair of orthopedic traumatic injury. Orthopedic traumatic injury will be defined as any traumatic injury resulting from a fall, collision (struck by or struck against), vehicle accident, assault or bike-related injury or fracture.

Exclusion Criteria:

Patients who do not speak English as their first language, or who are unable to respond to the survey's questions on their own will be excluded from study participation.

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Concussion Questionnaire

Arm Description

The questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a, which asks "At the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair.

Outcomes

Primary Outcome Measures

Estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2014
Last Updated
December 2, 2016
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02118220
Brief Title
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
Official Title
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to determine the number of children who have symptoms of a concussion at the time they are scheduled for orthopedic surgery at Boston Children's Hospital. It is currently unknown if anesthesia affects a child with a previously diagnosed concussion. This study is the first phase of a two-part study looking at the effects of anesthesia in children undergoing orthopedic surgery with a previous concussion. Currently, the decision to continue with surgery in patients with a diagnosed concussion is based on clinical judgment by the patients.
Detailed Description
Phase I's specific aim is to estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population. The first phase of this study requires a member of the research team to administer a paper questionnaire to all eligible, consented orthopedic surgery patients in either the Pre-operative Clinic or in the Day Surgery Unit over a period of four months. The research member will only approach adolescents that are scheduled for repair of orthopedic traumatic injury as defined in the inclusion criteria. The questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a, which asks "At the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair. If the participant scores higher than a 0 on the SCAT3 the results will be conveyed to the surgeon prior to the start of the scheduled surgical procedure. A copy of the completed SCAT3 will also be placed in the medical record. The decision to continue with surgery and need to possibly refer the patient to the Boston Children's Hospital Sports Concussion Clinic after the SCAT3 will remain at the surgeon's discretion. Information will be gathered from the questionnaire and the SCAT3, then entered into the REDcap database under a de-identified subject number.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Concussion Symptoms

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Concussion Questionnaire
Arm Type
Other
Arm Description
The questionnaire is specifically designed to elicit occurrence and symptoms of a concussion. If the patient answers yes to question 2a, which asks "At the time of the injury do you recall a blow to the head, neck, face or body that resulted in sustained symptoms of concussion (e.g., headache, dizziness, confusion, nausea, vomiting, etc.)?", the research team will administer the 22 item self-reporting symptom scale in the above mentioned SCAT3. The responses obtained from the questionnaire will be used to determine the incidence of symptomatic concussions, either known or unrecognized, in pediatric patients sustaining an orthopedic injury requiring surgical repair.
Intervention Type
Other
Intervention Name(s)
Concussion Questionnaire
Primary Outcome Measure Information:
Title
Estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients aged 5-21 years of age presenting for repair of orthopedic traumatic injury. Orthopedic traumatic injury will be defined as any traumatic injury resulting from a fall, collision (struck by or struck against), vehicle accident, assault or bike-related injury or fracture. Exclusion Criteria: Patients who do not speak English as their first language, or who are unable to respond to the survey's questions on their own will be excluded from study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Ferrari, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16983222
Citation
Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
Results Reference
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PubMed Identifier
18174937
Citation
Gessel LM, Fields SK, Collins CL, Dick RW, Comstock RD. Concussions among United States high school and collegiate athletes. J Athl Train. 2007 Oct-Dec;42(4):495-503.
Results Reference
background
PubMed Identifier
23479480
Citation
SCAT3. Br J Sports Med. 2013 Apr;47(5):259. No abstract available.
Results Reference
background
PubMed Identifier
23479481
Citation
Child SCAT3. Br J Sports Med. 2013 Apr;47(5):263. No abstract available.
Results Reference
background
PubMed Identifier
14712161
Citation
McCrea M, Hammeke T, Olsen G, Leo P, Guskiewicz K. Unreported concussion in high school football players: implications for prevention. Clin J Sport Med. 2004 Jan;14(1):13-7. doi: 10.1097/00042752-200401000-00003.
Results Reference
background
PubMed Identifier
19117869
Citation
Meehan WP 3rd, Bachur RG. Sport-related concussion. Pediatrics. 2009 Jan;123(1):114-23. doi: 10.1542/peds.2008-0309.
Results Reference
background
PubMed Identifier
23481161
Citation
Zhou Y, Kierans A, Kenul D, Ge Y, Rath J, Reaume J, Grossman RI, Lui YW. Mild traumatic brain injury: longitudinal regional brain volume changes. Radiology. 2013 Jun;267(3):880-90. doi: 10.1148/radiol.13122542. Epub 2013 Mar 12.
Results Reference
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Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I

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