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

Phase 1

Completed

• Conditions: Post Concussion Symptoms
• Interventions: Other: Concussion Questionnaire

• Registration Number: NCT02118220
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Study Start: 2014-05
• Primary Completion: 2015-04
• Study Completion: 2015-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Concussion Questionnaire	Concussion Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Estimate the incidence of symptomatic concussion in the pediatric orthopedic surgical population.	4 months

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States