Pain, AcuteNCT02980172
Pain Evaluation and Treatment in the Emergency Department
An observational study of Pain, Acute and Emergencies, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pain, Acute, Emergencies
- What is being tested?
- Pain evaluation
- How many people
- 31,942 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2016to Jun 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted during one year at GUH ED.
Who may be able to join
- adult (>= 16y) patients admitted at GUH ED during one year
- presenting complaint requiring pain evaluation accordingly to the SETS criteria
Who cannot join
- < 16 y
- presenting complaint that does not require a pain evaluation accordingly to the SETS criteria
Trial locations and contacts
1 site in 1 country.
About this study
All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale. At the end of the triage process the triage nurse has to choose an emergency level and a main presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain evaluation for 44 out of the SETS 98 presenting complaint.
The primary objective of the study is to determine whether pain is correctly evaluated when required by the SETS criteria. The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered when pain is present, and (2) to identify predictors of pain evaluation and treatment.
Read the detailed description
All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale. At the end of the triage process the triage nurse has to choose an emergency level and a main presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain evaluation for 44 out of the SETS 98 presenting complaint.
After this evaluation, a protocol standardize administration of analgesia for patients presenting pain.
The primary objective of the study is to determine whether pain is correctly evaluated when required by the SETS criteria for the 44 presenting complaints.
The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered when pain is present, and (2) to identify predictors of pain evaluation and treatment.
- Conditions
- Pain, Acute, Emergencies
- Being tested
- Pain evaluation
- Keywords
- triage
- Medical subject headings
- Acute Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain evaluationOther
Evaluation of pain using a numerical scale (1 to 10)
| Study group | Role | What they receive |
|---|---|---|
| Pain triage complaint | Patients admitted at GUH ED triaged with a main complaint requiring a pain evaluation. Receives: Other: Pain evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with appropriate pain evaluation
Percentage of patients with a documented assessement of pain using a numerical scale (0 to 10)
Measured: Within 24 hours after ED admission
Secondary outcomes (1)
Proportion of patients with appropriate pain treatment
Percentage of patients who received an appropriate treatment accordingly to the ED recommendations.
Measured: Within 24 hours after ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31,942 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier T. Rutschmann, University Hospital, Geneva
- Investigators
- Olivier T Rutschmann, MD, MPH, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980172
- Sponsor's protocol ID
- CCER 2016-00205
- Status last verified
- Jul 2017
- First submitted
- 24 Nov 2016
- Last updated
- 27 Jul 2017
- 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 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Evaluation and Treatment in the Emergency Department
- ClinicalTrials.gov ID
- NCT02980172
- Acronym / sponsor ID
- CCER 2016-00205
- Conditions
- Pain, Acute, Emergencies
- Keywords
- triage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31,942 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- 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.
All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale. At the end of the triage process the triage nurse has to choose an emergency level and a main presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain evaluation for 44 out of the SETS 98 presenting complaint.
The primary objective of the study is to determine whether pain is correctly evaluated when required by the SETS criteria. The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered when pain is present, and (2) to identify predictors of pain evaluation and treatment.
Detailed description
All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale. At the end of the triage process the triage nurse has to choose an emergency level and a main presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain evaluation for 44 out of the SETS 98 presenting complaint.
After this evaluation, a protocol standardize administration of analgesia for patients presenting pain.
The primary objective of the study is to determine whether pain is correctly evaluated when required by the SETS criteria for the 44 presenting complaints.
The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered when pain is present, and (2) to identify predictors of pain evaluation and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain triage complaint | – | Other: Pain evaluationPatients admitted at GUH ED triaged with a main complaint requiring a pain evaluation. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted during one year at GUH ED.
Key inclusion criteria (2 listed)
- adult (>= 16y) patients admitted at GUH ED during one year
- presenting complaint requiring pain evaluation accordingly to the SETS criteria
Key exclusion criteria (2 listed)
- < 16 y
- presenting complaint that does not require a pain evaluation accordingly to the SETS criteria
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 |
|---|---|---|
| Pain evaluationEvaluation of pain using a numerical scale (1 to 10) | Other | Pain triage complaint |
Primary outcome
Proportion of patients with appropriate pain evaluation
Time frame: Within 24 hours after ED admission
Percentage of patients with a documented assessement of pain using a numerical scale (0 to 10)
1 secondary outcome
Proportion of patients with appropriate pain treatment
Time frame: Within 24 hours after ED admission
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 27 Jul 2017.
- 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.
Olivier T Rutschmann, MD, MPH principal investigator
University Hospital, Geneva
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, Acute and Emergencies, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 inclusion and 2 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 27 Jul 2017. 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 Switzerland. 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?
Proportion of patients with appropriate pain evaluation (time frame: Within 24 hours after ED admission). 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 27 Jul 2017.