Head injuries are common among children and adolescents, with many of them assessed in emergency departments each year. Most children recover fast, with full resolution of symptoms as headache, dizziness or fatigue. A few, however, develop life-threatening complications (such as bleedings in/around the brain). It can be difficult to swiftly and accurately identify these patients in the emergency department. To aid in this task, decision support tools has been developed.
The goal of this observational study is to evaluate a Scandinavian tool developed to aid in management of children with head injuries seeking care in an emergency department.
The main research question is:
\- Are the Scandinavian guidelines for management of mild and moderate head trauma in children sensitive for patient-important outcomes?
Patients will be given the same treatment and recommendations for their head injury no matter if they participate or not in the study, as there is no intervention/ treatment group.
The doctor or nurse managing the child will collect information on patient history, signs and symptoms in the emergency department and management in an electronic case report form. Information on how the recovery period is collected both from medical records \>1 month after the emergency department visit, as well as via electronic questionnaires sent to the guardian at 1 month, 3 months and 4 months after the injury via e-mail and/or text message. Long-term outcome will also be examined (\>6 months).
Age <18 years.
Minor and moderate blunt head trauma (GCS 9 - 15) seeking medical assessment in an emergency department at a study hospital in Sweden or Norway.
Within 24 hours of trauma.
Informed oral consent from one guardian, and child if older than 14 years old, after receiving oral and written information about study.
Patient and/or guardian does not wish to participate in the study.
Patient included in other study that may affect the management/treatment in the emergency department.
Penetrating head injury (as those will always receive a CT scan).
Suspected child abuse / non-accidental trauma (NAT) denoted as suspected child abuse where the social services are informed (as they will always receive a CT scan).
Target population is children in Scandinavia with recent minor and moderate head trauma seeking care on emergency departments within participating in study.
Cohort
Prospective
Not listed
Number of participants with "clinically important intracranial injury (CIII)"
Defined as a composite variable of death, neurosurgery, admission to hospital ward two (2) days or more due to head injury or intubation one (1) day or more due to pathological traumatic CT findings.
Number of participants with death due to head injury
Defined as death as consequence of the TBI
Number of participants with neurosurgery due to TBI
Defined as need for any neurosurgical procedure or intervention, including sedation and intubation with controlled ventilation for non-surgical injuries such as diffuse axonal injury.
Number of participants with CT findings
Defined as a possibly trauma-related intracranial finding on CT-scan, such as cranial fractures or acute intracranial haemorrhage.
Number of participants with significant CT findings
Defined as a possibly trauma-related intracranial finding on CT-scan, such as cranial fractures or acute intracranial haemorrhage, but not including undislocated skull fractures
Participant rating on GOS-E PEDS Score
Clinical outcome according to GOS-E PEDS (paediatric Glasgow Outcome Scale extended version), score 1-8 (higher score indicate worse outcome), assessed by parent.
Participant rating on Post Concussion Symptom Inventory - Parent (PCSI-P) assessment
Clinical outcome on PCSI-P assessed by parent on a 20-item scale. Each item assessed on a 7-point scale (0 = not a problem, 6 = severe problem).
Participant rating on Mental Fatigue Scale
Clinical outcome on modified Mental Fatigue Scale assessed by parent. 15 items assessed 0 - 2/3. Higher value indicates a higher degree of severity. One question on variation of symptoms over day. One question on pre-injury status.
Long-term outcome
Assessment of remaining post concussive symptoms at 5 years after TBI. Assessed by GOS-E PEDS, PCSI-P and Mental Fatigue Scale.
Click on the lead sponsor to view all of their trials.
