NCT02118220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

April 16, 2014

Last Update Submit

December 2, 2016

Conditions

Post Concussion Symptoms

Outcome Measures

Primary Outcomes (1)

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

    4 months

Study Arms (1)

Concussion Questionnaire

OTHER

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.

Other: Concussion Questionnaire

Interventions

Concussion QuestionnaireOTHER
Concussion Questionnaire

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (7)

  • 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.

    PMID: 16983222BACKGROUND

  • 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.

    PMID: 18174937BACKGROUND

  • SCAT3. Br J Sports Med. 2013 Apr;47(5):259. No abstract available.

    PMID: 23479480BACKGROUND

  • Child SCAT3. Br J Sports Med. 2013 Apr;47(5):263. No abstract available.

    PMID: 23479481BACKGROUND

  • 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.

    PMID: 14712161BACKGROUND

  • Meehan WP 3rd, Bachur RG. Sport-related concussion. Pediatrics. 2009 Jan;123(1):114-23. doi: 10.1542/peds.2008-0309.

    PMID: 19117869BACKGROUND

  • 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.

    PMID: 23481161BACKGROUND

MeSH Terms

Conditions

Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain ConcussionHead Injuries, ClosedCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Lynne Ferrari, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Perioperative Anesthesia

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

December 1, 2015

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

US(1)