Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT02118220
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Effects of Anesthesia on Pediatric Surgical Patients With a History of Concussion - Phase I
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: