Pediatric Pain Assessment in the Emergency Department

Pain Clinical Trial

Official title:

Pediatric Pain Assessment in the Emergency Department

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03157882
• Other study ID #: 09-16-31E
• Status: Terminated
• Start date: August 13, 2016
• Est. completion date: April 11, 2019

Study information

• Verified date: August 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To examine pediatric pain assessment in the Emergency Department

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: April 11, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies
• Pain

Locations

Country	Name	City	State
United States	Simone Lorraine Lawson	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative Assessment (Phase 1 - Primary Aim)	Adherence to a validated script for pain scale administration (dichotomous value - yes/no)	One day
Primary	Wong-Baker FACES ® Pain Rating Scale (WBF)	The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Change in pain scale response before and after analgesic intervention that correlates with a subjective description of change in pain (better or worse).	One day
Primary	Faces Pain Scale - Revised (FPS-R)	The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Change in pain scale response before and after analgesic intervention that correlates with a subjective description of change in pain (better or worse).	One day
Secondary	Convergent reliability between WBF and FPS-R (Phase 2 Secondary Aim #1)	Convergent reliability between WBF and FPS-R - determined by pre and post analgesia reports of pain using the FPS-R and WBF by the patient. Both scales show a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".	One day
Secondary	Pre and Post Analgesia Pain Scores Using WBF and FPS-R as Reported by Patients and Caregivers	Inter-rater reliability between children and caregivers when using WBF and FPS-R, determined by pre and post analgesia reports of pain using the FPS-R and WBF by both the patient and caregiver. Both scales show a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable".	One day