Pain, AcutePIMPERNELNCT03881982
A Novel Electronic Method of Collecting Pain Scores in the Emergency Department
A study testing PIMPERNEL Novel Electronic Log: Pain display can be seen and PIMPERNEL Novel Electronic Log: Pain display is hidden in people with Pain, Acute, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Can a novel electronic display of pain be successfully used in the emergency department and does it (1) change analgesic prescription and (2) change amount of pain experienced? Pain is a common symptom in emergency care. As patients are seldom reassessed, staff may not be aware of pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- PIMPERNEL Novel Electronic Log: Pain display can be seen and PIMPERNEL Novel Electronic Log: Pain display is hidden
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2017to 31 Jul 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (18 years and over)
- underlying condition giving rise to significant pain (initial VAS pain score of 5 or more)
- likely to be staying in the hospital for at least 2 hours
- willing and able to give informed consent
- able to understand and speak a good level of English
Who cannot join
- children (under 18 years)
- patients not willing to undergo routine care (analgesic treatment)
- patients who do not have capacity to consent
- patients who are unwilling or unable to give informed consent
- prisoners
- patients who cannot understand the study information in English
- currently participating in another clinical trial as far as can be determined from information available at the time of assessment
- patients who have a physical or visual disability which will prevent them from holding or using the pain display
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
About this study
Official title: Patient Input Monitoring of Pain in the Emergency Room: Novel Electronic Log (PIMPERNEL). A Randomised Controlled Trial of an Electronic Pain Score Display in Adults in the Emergency Department
Can a novel electronic display of pain be successfully used in the emergency department and does it (1) change analgesic prescription and (2) change amount of pain experienced? Pain is a common symptom in emergency care. As patients are seldom reassessed, staff may not be aware of pain. Currently, members of nursing or medical staff need to ask patients about their pain and record it manually using a visual analogue scale from 0-10.
The new electronic display uses buttons to represent a pain scale from 0 (no pain) to 10 (worst pain). Patients will select the number that best corresponds to their pain every 15 minutes. In the experimental group, the score will be displayed on a screen. In the control group, the score will not be displayed. The investigators will compare the overall amount of pain in both groups, and will look at their pain management (painkillers prescribed). The investigators will also ask patients and staff for their opinions on the display.
The study will include adult patients in the emergency department at Leicester Royal Infirmary with an initial pain score of 5 or more who are able to make a decision about whether to participate. Participants will also need to be likely to stay in the hospital for more than 2 hours to allow the investigators to gather enough useful data. The study will recruit 200 participants. If the study can demonstrate that the monitor is acceptable to patients and staff and results in improved pain management, it is a low cost intervention which could be widely implemented within the NHS. It also has the potential for being used in other areas such as surgical wards. The investigators have previously found that 300-400 patients per week in the department have moderate to severe pain and might therefore benefit from this monitor.
- Conditions
- Pain, Acute
- Being tested
- PIMPERNEL Novel Electronic Log: Pain display can be seen, PIMPERNEL Novel Electronic Log: Pain display is hidden
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIMPERNEL Novel Electronic Log: Pain display can be seenOther
Pain scores are displayed on the screen when the participant presses the corresponding button
PIMPERNEL Novel Electronic Log: Pain display is hiddenOther
Participants press the buttons to record their pain score but the score is not on display (the screen is turned backwards).
| Study group | Role | What they receive |
|---|---|---|
| PIMPERNEL Novel Electronic Log - intervention | Experimental | The display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level.
The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet). Receives: Other: PIMPERNEL Novel Electronic Log: Pain display can be seen |
| PIMPERNEL Novel Electronic Log - control | Other | The display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level.
The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet). Receives: Other: PIMPERNEL Novel Electronic Log: Pain display is hidden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reported by the patient:11 point numerical pain scale
Data collected from the display using the 11 point numerical pain scale. The area under the curve will be compared between the intervention and control groups. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
Measured: Up to 6 hours
Secondary outcomes (8)
Proportion of possible scores recorded by patients
Measured: Up to 6 hours
Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours
The scores recorded by the participants at 2 and 4 hours into their hospital stay will be compared with the scores recorded by nursing staff in the electronic record. The 11 point numerical rating scale is used for both measurements. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
Measured: Up to 6 hours
Understanding the pattern of pain (shape of the curve of pain scores) over the time of the ED stay
Measured: Up to 6 hours
Recording time to second dose of analgesia and whether there is a pattern to this
Measured: Up to 6 hours
Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name)
The dose, time prescribed, time administered and name of analgesia given pre-hospital and whilst in hospital will be recorded and a comparison made between the groups. This is a feasibility study only so exact outcome depends upon what data can be collected.
Measured: Up to 6 hours
Opinion of patients
Uses a short (4 question) questionnaire designed for this study. Questions on ease of use, whether the monitor is a good idea, whether participants would use it again in the future and whether it improved their experience as a patient, plus a comments box.
Questions: 1) How easy was it to use the pain monitor? (very easy, easy, no opinion, difficult, very difficult) 2) I think that the pain monitor is a good idea (strongly agree, agree, no opinion, disagree, strongly disagree) 3) I would use the monitor again in the future (strongly agree, agree, no opinion, disagree, strongly disagree) 4) The pain monitor improved my experience as a patient (strongly agree, agree, no opinion, disagree, strongly disagree)
Measured: Up to 6 hours
Opinion of staff (including their opinion of whether patients press the button for reasons other than pain)
Short (4 question) questionnaire designed for the study. Questions on whether the display is practical to use in the Emergency Department, whether they think it is a good idea, whether it is likely to improve the patient experience and whether a patient used the display to get their attention for a reason other than pain. Also has a comments box.
Questions: 1) The pain display is practical to use in the Emergency Department (strongly agree, agree, no opinion, disagree, strongly disagree) 2) I think that the pain display is a good idea (strongly agree, agree, no opinion, disagree, strongly disagree) 3) The pain display is likely to improve the patient experience (strongly agree, agree, no opinion, disagree, strongly disagree) 4) A patient used the pain display to get my attention for a reason other than pain (yes, not sure, no)
Measured: Up to 6 hours
Opinion of researchers regarding any likely stratification needs
Subjective opinion of researchers having completed the study on whether stratification would be required in future studies. No specific measurement used.
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start3 Aug 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy J Coats, Prof, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881982
- Sponsor's protocol ID
- 0588
- Other IDs
- IRAS 210798
- Acronym
- PIMPERNEL
- Status last verified
- Jan 2019
- First submitted
- 28 Jan 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are collecting feasibility data only in this trial.
Publications
Johnston CC, Gagnon AJ, Fullerton L, Common C, Ladores M, Forlini S. One-week survey of pain intensity on admission to and discharge from the emergency department: a pilot study. J Emerg Med. 1998 May-Jun;16(3):377-82. doi: 10.1016/s0736-4679(98)00012-2.
PubMed 9610963Cordell WH, Keene KK, Giles BK, Jones JB, Jones JH, Brizendine EJ. The high prevalence of pain in emergency medical care. Am J Emerg Med. 2002 May;20(3):165-9. doi: 10.1053/ajem.2002.32643.
PubMed 11992334Ducharme J, Barber C. A prospective blinded study on emergency pain assessment and therapy. J Emerg Med. 1995 Jul-Aug;13(4):571-5. doi: 10.1016/0736-4679(95)80023-9.
PubMed 7594383Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007 Jun;8(6):460-6. doi: 10.1016/j.jpain.2006.12.005. Epub 2007 Feb 15.
PubMed 17306626Motov SM, Khan AN. Problems and barriers of pain management in the emergency department: Are we ever going to get better? J Pain Res. 2008 Dec 9;2:5-11.
PubMed 21197290Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.
PubMed 15039693Loryman B, Davies F, Chavada G, Coats T. Consigning "brutacaine" to history: a survey of pharmacological techniques to facilitate painful procedures in children in emergency departments in the UK. Emerg Med J. 2006 Nov;23(11):838-40. doi: 10.1136/emj.2006.034140.
PubMed 17057133Brown JC, Klein EJ, Lewis CW, Johnston BD, Cummings P. Emergency department analgesia for fracture pain. Ann Emerg Med. 2003 Aug;42(2):197-205. doi: 10.1067/mem.2003.275.
PubMed 12883507Stahmer SA, Shofer FS, Marino A, Shepherd S, Abbuhl S. Do quantitative changes in pain intensity correlate with pain relief and satisfaction? Acad Emerg Med. 1998 Sep;5(9):851-7. doi: 10.1111/j.1553-2712.1998.tb02811.x.
PubMed 9754496FitzGerald G, Jelinek GA, Scott D, Gerdtz MF. Emergency department triage revisited. Emerg Med J. 2010 Feb;27(2):86-92. doi: 10.1136/emj.2009.077081.
PubMed 20156855Telfer P, Criddle J, Sandell J, Davies F, Morrison I, Challands J. Intranasal diamorphine for acute sickle cell pain. Arch Dis Child. 2009 Dec;94(12):979-80. doi: 10.1136/adc.2008.138875. Epub 2009 Mar 25.
PubMed 19321506France J, Smith S, Smith L. The College of Emergency Medicine Best Practice Guideline: Management of Pain in Adults. 2014.
Menendez ME, Bot AG, Hageman MG, Neuhaus V, Mudgal CS, Ring D. Computerized adaptive testing of psychological factors: relation to upper-extremity disability. J Bone Joint Surg Am. 2013 Oct 16;95(20):e149. doi: 10.2106/JBJS.L.01614.
PubMed 24132364Smith JE, Rockett M, Squire R, Hayward CJ, Creanor S, Ewings P, Barton A, Pritchard C, Benger JR. PAin SoluTions In the Emergency Setting (PASTIES); a protocol for two open-label randomised trials of patient-controlled analgesia (PCA) versus routine care in the emergency department. BMJ Open. 2013 Feb 14;3(2):e002577. doi: 10.1136/bmjopen-2013-002577. Print 2013.
PubMed 23418302
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Input Monitoring of Pain in the Emergency Room: Novel Electronic Log (PIMPERNEL). A Randomised Controlled Trial of an Electronic Pain Score Display in Adults in the Emergency Department
- ClinicalTrials.gov ID
- NCT03881982
- Acronym / sponsor ID
- PIMPERNEL / 0588
- Conditions
- Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 20 Mar 2019 (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.
Can a novel electronic display of pain be successfully used in the emergency department and does it (1) change analgesic prescription and (2) change amount of pain experienced? Pain is a common symptom in emergency care. As patients are seldom reassessed, staff may not be aware of pain. Currently, members of nursing or medical staff need to ask patients about their pain and record it manually using a visual analogue scale from 0-10.
The new electronic display uses buttons to represent a pain scale from 0 (no pain) to 10 (worst pain). Patients will select the number that best corresponds to their pain every 15 minutes. In the experimental group, the score will be displayed on a screen. In the control group, the score will not be displayed. The investigators will compare the overall amount of pain in both groups, and will look at their pain management (painkillers prescribed). The investigators will also ask patients and staff for their opinions on the display.
The study will include adult patients in the emergency department at Leicester Royal Infirmary with an initial pain score of 5 or more who are able to make a decision about whether to participate. Participants will also need to be likely to stay in the hospital for more than 2 hours to allow the investigators to gather enough useful data. The study will recruit 200 participants. If the study can demonstrate that the monitor is acceptable to patients and staff and results in improved pain management, it is a low cost intervention which could be widely implemented within the NHS. It also has the potential for being used in other areas such as surgical wards. The investigators have previously found that 300-400 patients per week in the department have moderate to severe pain and might therefore benefit from this monitor.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIMPERNEL Novel Electronic Log - intervention | Experimental | Other: PIMPERNEL Novel Electronic Log: Pain display can be seenThe display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level. The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet). |
| PIMPERNEL Novel Electronic Log - control | Other | Other: PIMPERNEL Novel Electronic Log: Pain display is hiddenThe display is an electronic version of the 11 point NRS. An audible 'beep' every 15 minutes prompts the patient to record their pain level. The display measures 122mm x 30mm x 15mm. Through a wireless connection, the data from the display are transmitted to a display unit (a Nexus tablet). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult (18 years and over)
- underlying condition giving rise to significant pain (initial VAS pain score of 5 or more)
- likely to be staying in the hospital for at least 2 hours
- willing and able to give informed consent
- able to understand and speak a good level of English
Key exclusion criteria (8 listed)
- children (under 18 years)
- patients not willing to undergo routine care (analgesic treatment)
- patients who do not have capacity to consent
- patients who are unwilling or unable to give informed consent
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIMPERNEL Novel Electronic Log: Pain display can be seenPain scores are displayed on the screen when the participant presses the corresponding button | Other | PIMPERNEL Novel Electronic Log - intervention |
| PIMPERNEL Novel Electronic Log: Pain display is hiddenParticipants press the buttons to record their pain score but the score is not on display (the screen is turned backwards). | Other | PIMPERNEL Novel Electronic Log - control |
Primary outcome
Pain reported by the patient:11 point numerical pain scale
Time frame: Up to 6 hours
Data collected from the display using the 11 point numerical pain scale. The area under the curve will be compared between the intervention and control groups. The Numerical Rating Scale is a scale from 0-10 (whole numbers only, where 0 represents 'no pain' and 10 represents 'worst pain ever').
8 secondary outcomes
Proportion of possible scores recorded by patients
Time frame: Up to 6 hours
Comparison of pain recorded on the display (closest minute) with verbal pain assessment at 2 and 4 hours
Time frame: Up to 6 hours
Understanding the pattern of pain (shape of the curve of pain scores) over the time of the ED stay
Time frame: Up to 6 hours
Recording time to second dose of analgesia and whether there is a pattern to this
Time frame: Up to 6 hours
Use of analgesia in intervention and control groups (dose, time prescribed, time administered and name)
Time frame: Up to 6 hours
Opinion of patients
Time frame: Up to 6 hours
Opinion of staff (including their opinion of whether patients press the button for reasons other than pain)
Time frame: Up to 6 hours
Opinion of researchers regarding any likely stratification needs
Time frame: Up to 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Background: PubMed 9610963Johnston CC, Gagnon AJ, Fullerton L, Common C, Ladores M, Forlini S. One-week survey of pain intensity on admission to and discharge from the emergency department: a pilot study. J Emerg Med. 1998 May-Jun;16(3):377-82. doi: 10.1016/s0736-4679(98)00012-2.
- Background: PubMed 11992334Cordell WH, Keene KK, Giles BK, Jones JB, Jones JH, Brizendine EJ. The high prevalence of pain in emergency medical care. Am J Emerg Med. 2002 May;20(3):165-9. doi: 10.1053/ajem.2002.32643.
- Background: PubMed 7594383Ducharme J, Barber C. A prospective blinded study on emergency pain assessment and therapy. J Emerg Med. 1995 Jul-Aug;13(4):571-5. doi: 10.1016/0736-4679(95)80023-9.
- Background: PubMed 17306626Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007 Jun;8(6):460-6. doi: 10.1016/j.jpain.2006.12.005. Epub 2007 Feb 15.
- Background: PubMed 21197290Motov SM, Khan AN. Problems and barriers of pain management in the emergency department: Are we ever going to get better? J Pain Res. 2008 Dec 9;2:5-11.
- Background: PubMed 15039693Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.
- Background: PubMed 17057133Loryman B, Davies F, Chavada G, Coats T. Consigning "brutacaine" to history: a survey of pharmacological techniques to facilitate painful procedures in children in emergency departments in the UK. Emerg Med J. 2006 Nov;23(11):838-40. doi: 10.1136/emj.2006.034140.
- Background: PubMed 12883507Brown JC, Klein EJ, Lewis CW, Johnston BD, Cummings P. Emergency department analgesia for fracture pain. Ann Emerg Med. 2003 Aug;42(2):197-205. doi: 10.1067/mem.2003.275.
- Background: PubMed 9754496Stahmer SA, Shofer FS, Marino A, Shepherd S, Abbuhl S. Do quantitative changes in pain intensity correlate with pain relief and satisfaction? Acad Emerg Med. 1998 Sep;5(9):851-7. doi: 10.1111/j.1553-2712.1998.tb02811.x.
- Background: PubMed 20156855FitzGerald G, Jelinek GA, Scott D, Gerdtz MF. Emergency department triage revisited. Emerg Med J. 2010 Feb;27(2):86-92. doi: 10.1136/emj.2009.077081.
- Background: PubMed 19321506Telfer P, Criddle J, Sandell J, Davies F, Morrison I, Challands J. Intranasal diamorphine for acute sickle cell pain. Arch Dis Child. 2009 Dec;94(12):979-80. doi: 10.1136/adc.2008.138875. Epub 2009 Mar 25.
- BackgroundFrance J, Smith S, Smith L. The College of Emergency Medicine Best Practice Guideline: Management of Pain in Adults. 2014.
- Individual participant dataSharing planned: No. We are collecting feasibility data only in this trial.
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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.
Timothy J Coats, Prof principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIMPERNEL Novel Electronic Log: Pain display can be seen and PIMPERNEL Novel Electronic Log: Pain display is hidden in people with Pain, Acute, run by University of Leicester at 1 site in United Kingdom.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 30 Jan 2020. 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain reported by the patient:11 point numerical pain scale (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881982, which also lists 14 linked publications.
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 30 Jan 2020.