PainNCT03157882
Pediatric Pain Assessment in the Emergency Department
An observational study of Pain and Acute Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To examine pediatric pain assessment in the Emergency Department Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute Pain
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2016to 11 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients presenting to the emergency department with complaint of pain
Who may be able to join
- verbal patients
- pain score ≥ 6/10
- caregiver speaks English or Spanish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Simone Lorraine Lawson
Charlotte, North Carolina, 28277
About this study
To examine pediatric pain assessment in the Emergency Department
Read the 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.
- Conditions
- Pain, Acute Pain
- Keywords
- pediatric, children, Faces Pain Scale Revised, Wong Baker FACES, pain scales, BRIGANCE
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Pediatric patients presenting to the emergency department with acute painful conditions (please see inclusion and exclusion criteria) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Assessment (Phase 1 - Primary Aim)
Adherence to a validated script for pain scale administration (dichotomous value - yes/no)
Measured: One day
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).
Measured: One day
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).
Measured: One day
Secondary outcomes (2)
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".
Measured: One day
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".
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start13 Aug 2016
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Why it stopped: loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone L Lawson, MD, Principal investigator, Wake Forest University Health SciencesMelanie Hogg, Study director, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157882
- Sponsor's protocol ID
- 09-16-31E
- Status last verified
- Aug 2019
- First submitted
- 11 May 2017
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Pain Assessment in the Emergency Department
- ClinicalTrials.gov ID
- NCT03157882
- Acronym / sponsor ID
- 09-16-31E
- Conditions
- Pain, Acute Pain
- Keywords
- pediatric, children, Faces Pain Scale Revised, Wong Baker FACES, pain scales, BRIGANCE
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: loss of funding
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 13 Aug 2016 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –Pediatric patients presenting to the emergency department with acute painful conditions (please see inclusion and exclusion criteria) |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients presenting to the emergency department with complaint of pain
Key inclusion criteria (3 listed)
- verbal patients
- pain score ≥ 6/10
- caregiver speaks English or Spanish
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative Assessment (Phase 1 - Primary Aim)
Time frame: One day
Adherence to a validated script for pain scale administration (dichotomous value - yes/no)
Wong-Baker FACES ® Pain Rating Scale (WBF)
Time frame: One day
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).
Faces Pain Scale - Revised (FPS-R)
Time frame: One day
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).
2 secondary outcomes
Convergent reliability between WBF and FPS-R (Phase 2 Secondary Aim #1)
Time frame: One day
Pre and Post Analgesia Pain Scores Using WBF and FPS-R as Reported by Patients and Caregivers
Time frame: One day
Results and safety
The study was stopped early (reason given: loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone L Lawson, MD principal investigator
Wake Forest University Health Sciences
Melanie Hogg study director
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Acute Pain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: loss of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Assessment (Phase 1 - Primary Aim) (time frame: One day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.