Clinical trial NCT03157882: Pediatric Pain Assessment in the Emergency Department
Official title: Pediatric Pain Assessment in the Emergency Department
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain
Acute Pain
Keywords: pediatric
children
Faces Pain Scale Revised
Wong Baker FACES
pain scales
BRIGANCE
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 46
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients presenting to the emergency department with complaint of pain

Brief summary: To examine pediatric pain assessment in the Emergency Department

Detailed description: Phase 1 is a qualitative assessment of how pain is currently evaluated in the pediatric Emergency Department (ED). Initial triage encounters will be observed and audio recorded. In addition to determining how often the Wong Baker FACES Pain Rating Scale (WBF) is administered with the intended script, the investigators will determine if there are common variations from the recommended script. The investigators will also evaluate how often a caregiver's perception of the child's pain is considered when completing the WBF.

Phase 2 is a quantitative assessment to determine if neurocognitive development impacts the responsivity of the WBF and the Faces Pain Scale - Revised (FPS-R) as well as the cognitive age equivalent required to use these scales accurately. Patients presenting with acute pain will report their level of pain before and after analgesic intervention using both the WBF and the FPS-R. They will also subjectively report their change in pain following analgesic intervention. Once the patient's pain has improved, he/she will complete the BRIGANCE Early Childhood Screens III to determine his/her cognitive age equivalent. He/she will also complete a series of tasks aimed to assess ability to successfully use the WBF and FPS-R (matching, grouping, classification, and seriation skills). The results of the child's self-report of pain will also be compared to the caregiver's estimate of the child's pain.

Eligibility criteria: Inclusion Criteria:

* verbal patients
* pain score ≥ 6/10
* caregiver speaks English or Spanish

Exclusion Criteria:

* altered mental status
* history of traumatic brain injury (TBI)
* history of developmental delay
* history of Autism
* history of chronic pain, defined as persistent or recurrent pain in children with chronic health conditions
* non-verbal patients

Primary outcomes:
measure: Qualitative Assessment (Phase 1 - Primary Aim)
timeFrame: One day
measure: Wong-Baker FACES ® Pain Rating Scale (WBF)
timeFrame: One day
measure: Faces Pain Scale - Revised (FPS-R)
timeFrame: One day
Secondary outcomes:
measure: Convergent reliability between WBF and FPS-R (Phase 2 Secondary Aim #1)
timeFrame: One day
measure: Pre and Post Analgesia Pain Scores Using WBF and FPS-R as Reported by Patients and Caregivers
timeFrame: One day
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Simone Lorraine Lawson
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Simone L Lawson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Melanie Hogg
role: STUDY_DIRECTOR
References: