Pain, PostoperativeNCT01413724
Survey of Postoperative Pain and Pain Management in Norwegian Hospitals
An observational study of Pain, Postoperative, run by Norwegian University of Science and Technology.
Trial summary
The study is a national survey of pain and pain management to surgical patients in Norwegian Hospitals. Data on pain management are gathered from patient records and data on pain and patient satisfaction are gathered as patients' self report. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had surgery the previous day and still are hospitalized. Patients must give informed consent to participate.
Who may be able to join
- Surgery previous day
Who cannot join
- Declined participation
- Unable to communicate (delirious, sedated, intubated)
- Does not read and speak Norwegian
- Patient not available (for instance having physiotherapy og examinations during data collection)
About this study
The study is a national survey of pain and pain management to surgical patients in Norwegian Hospitals. Data on pain management are gathered from patient records and data on pain and patient satisfaction are gathered as patients' self report.
- Conditions
- Pain, Postoperative
- Keywords
- Administered analgesic therapy
- Medical subject headings
- Pain, Postoperative
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 |
|---|---|---|
| Surgical patients | PAtients who had surgery the previous day and are still hospitalized |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Proportion of patients who report average pain intensity >3 on 11 point pain Numerical Rating scale for the first 24 hours after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Pain Association
- Responsible party
- Sponsor
- Investigators
- Olav M Fredheim, MD, PhD, MBA, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413724
- Sponsor's protocol ID
- 2010/747a
- Status last verified
- Aug 2016
- First submitted
- 22 Jul 2010
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fredheim OM, Kvarstein G, Undall E, Stubhaug A, Rustoen T, Borchgrevink PC. [Postoperative pain in patients admitted to Norwegian hospitals]. Tidsskr Nor Laegeforen. 2011 Sep 20;131(18):1763-7. doi: 10.4045/tidsskr.10.1129. Norwegian.
PubMed 21946593Fredheim OM, Borchgrevink PC, Kvarstein G. [Post-operative pain management in hospitals]. Tidsskr Nor Laegeforen. 2011 Sep 20;131(18):1772-6. doi: 10.4045/tidsskr.10.1184. Norwegian.
PubMed 21946595
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Postoperative Pain and Pain Management in Norwegian Hospitals
- ClinicalTrials.gov ID
- NCT01413724
- Acronym / sponsor ID
- 2010/747a
- Conditions
- Pain, Postoperative
- Keywords
- Administered analgesic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Pain Association
- Study start
- Jun 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Aug 2011 (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.
The study is a national survey of pain and pain management to surgical patients in Norwegian Hospitals. Data on pain management are gathered from patient records and data on pain and patient satisfaction are gathered as patients' self report.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | –PAtients who had surgery the previous day and are still hospitalized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had surgery the previous day and still are hospitalized. Patients must give informed consent to participate.
Key inclusion criteria (1 listed)
- Surgery previous day
Key exclusion criteria (4 listed)
- Declined participation
- Unable to communicate (delirious, sedated, intubated)
- Does not read and speak Norwegian
- Patient not available (for instance having physiotherapy og examinations during data collection)
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
pain
Time frame: 24 hours
Proportion of patients who report average pain intensity >3 on 11 point pain Numerical Rating scale for the first 24 hours after surgery
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 3 Aug 2016.
- Results publication: PubMed 21946593Fredheim OM, Kvarstein G, Undall E, Stubhaug A, Rustoen T, Borchgrevink PC. [Postoperative pain in patients admitted to Norwegian hospitals]. Tidsskr Nor Laegeforen. 2011 Sep 20;131(18):1763-7. doi: 10.4045/tidsskr.10.1129. Norwegian.
- Results publication: PubMed 21946595Fredheim OM, Borchgrevink PC, Kvarstein G. [Post-operative pain management in hospitals]. Tidsskr Nor Laegeforen. 2011 Sep 20;131(18):1772-6. doi: 10.4045/tidsskr.10.1184. Norwegian.
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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.
Olav M Fredheim, MD, PhD, MBA principal investigator
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Norwegian University of Science and Technology.
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 1 inclusion and 4 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 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: 24 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 NCT01413724, which also lists 2 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 3 Aug 2016.