PainPainNCT01386307
Prevalence of Pain in Inpatient at the Hospital Italiano de Buenos Aires
An observational study of Pain, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The purpose of this study is to determine the prevalence of patients with acute and chronic pain in the area of inpatient at the Hospital Italiano de Buenos Aires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 800 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2011to Apr 2012
- 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: Patients older than 18 years, hospitalized at the Hospital Italiano de Buenos Aires and admitted 24 to 72 hours before the evaluation.
Who may be able to join
- Adult patients over 18 years.
- Evaluated at 48 hours after hospital admission in areas general hospitalization, coronary care unit, adult intensive care, intermediate care and day hospital of the Hospital Italiano Central
Who cannot join
- Refusal to participate in the study or the informed consent process.
- Inability to understand or express pain (aphasia, dementia).
- Alteration ef the sensory.
- Language other than Spanish.
- Inpatient at the emergency room.
- Presence of acute confusion or delirium.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires, 1181
About this study
Official title: ¿Cuál es la Prevalencia de Dolor en internación en el Hospital Italiano?
The purpose of this study is to determine the prevalence of patients with acute and chronic pain in the area of inpatient at the Hospital Italiano de Buenos Aires.
Read the detailed description
The diagnosis and treatment of pain during hospitalization are becoming increasingly important. In recent decades there have been articles that explain that pain is underdiagnosed, that there are patients who do not receive treatment or that it fails to decrease pain intensity. It has now been shown that pain is a common problem during hospitalization, showing a prevalence of 38 to 91% depending on the population studied.
Published studies show that there are three types of pain during hospitalization: acute or chronic pain that motivates the admission and continues during hospitalization, pain that appears during hospitalization but was not the cause of the admission or associated with health care, and,pain that appears during the hospitalization associated with health care. To complete the description of patients with pain during hospitalization it has been suggested the existence of a fourth group of patients presenting with chronic pain that does not motivate the admission but persists and does not interfere during hospitalization. In a study evaluating the Italian population shows that the prevalence of pain is modified by marital status and age, and the intensity of pain increases with time evolution of pain and days of hospital stay. Some studies, mainly in Europe, show that the use of analgesics is high but the adherence to guideline recommendations for treatment of pain is low, or that the presence of pain is not recorded in the medical chart compared to the indication of analgesic treatment.
These results demonstrate the need to determine the prevalence of pain in hospitalization at each institution, distinguishing the case of pain prior to admission or appearing during the same (or motivation), evaluating the indication of pain at each hospital, in order to learn about the current situation and design and implement actions to improve pain management in this institution.
- Conditions
- Pain
- Keywords
- Pain, Hospitalization
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pain
Presence of pain in the last 24 hours of hospitalization
Measured: within 48 to 72 hours after admission to hospital
Secondary outcomes (8)
Response to analgesic treatment
Measured: within 48 to 72 hours after admission to hospital
The cause of pain during hospitalization
Measured: within 48 to 72 hours after admission to hospital
Number of patients reporting pain to heath care personnel
Measured: within 48 to 72 hours after admission to hospital
Proportion of physicians who know the patient is in pain according to the evolution in medical chart
Measured: within 48 to 72 hours after admission to hospital
Number of nurses who know that the patient has pain according to medical chart
Measured: within 48 to 72 hours after admission to hospital
Proportion of hospitalized patients treated for pain
Measured: within 48 to 72 hours after admission to hospital
Type of analgesic treatment received
Measured: within 48 to 72 hours after admission to hospital
Number of patients with pain evaluated by a pain specialist
Measured: within 48 to 72 hours after admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionApr 2012
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.
- 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
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Diego Giunta, MD, Study director, Hospital Italiano de Buenos AiresMaria L Bechelli, MD, Principal investigator, Hospital Italiano de Buenos AiresJimena Vicens, MD, Study chair, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386307
- Sponsor's protocol ID
- 1670
- Acronym
- Pain
- Status last verified
- Aug 2019
- First submitted
- 27 May 2011
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ¿Cuál es la Prevalencia de Dolor en internación en el Hospital Italiano?
- ClinicalTrials.gov ID
- NCT01386307
- Acronym / sponsor ID
- Pain / 1670
- Conditions
- Pain
- Keywords
- Pain, Hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 Jul 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 purpose of this study is to determine the prevalence of patients with acute and chronic pain in the area of inpatient at the Hospital Italiano de Buenos Aires.
Detailed description
The diagnosis and treatment of pain during hospitalization are becoming increasingly important. In recent decades there have been articles that explain that pain is underdiagnosed, that there are patients who do not receive treatment or that it fails to decrease pain intensity. It has now been shown that pain is a common problem during hospitalization, showing a prevalence of 38 to 91% depending on the population studied.
Published studies show that there are three types of pain during hospitalization: acute or chronic pain that motivates the admission and continues during hospitalization, pain that appears during hospitalization but was not the cause of the admission or associated with health care, and,pain that appears during the hospitalization associated with health care. To complete the description of patients with pain during hospitalization it has been suggested the existence of a fourth group of patients presenting with chronic pain that does not motivate the admission but persists and does not interfere during hospitalization. In a study evaluating the Italian population shows that the prevalence of pain is modified by marital status and age, and the intensity of pain increases with time evolution of pain and days of hospital stay. Some studies, mainly in Europe, show that the use of analgesics is high but the adherence to guideline recommendations for treatment of pain is low, or that the presence of pain is not recorded in the medical chart compared to the indication of analgesic treatment.
These results demonstrate the need to determine the prevalence of pain in hospitalization at each institution, distinguishing the case of pain prior to admission or appearing during the same (or motivation), evaluating the indication of pain at each hospital, in order to learn about the current situation and design and implement actions to improve pain management in this institution.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years, hospitalized at the Hospital Italiano de Buenos Aires and admitted 24 to 72 hours before the evaluation.
Key inclusion criteria (2 listed)
- Adult patients over 18 years.
- Evaluated at 48 hours after hospital admission in areas general hospitalization, coronary care unit, adult intensive care, intermediate care and day hospital of the Hospital Italiano Central
Key exclusion criteria (6 listed)
- Refusal to participate in the study or the informed consent process.
- Inability to understand or express pain (aphasia, dementia).
- Alteration ef the sensory.
- Language other than Spanish.
- Inpatient at the emergency room.
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
Prevalence of pain
Time frame: within 48 to 72 hours after admission to hospital
Presence of pain in the last 24 hours of hospitalization
8 secondary outcomes
Response to analgesic treatment
Time frame: within 48 to 72 hours after admission to hospital
The cause of pain during hospitalization
Time frame: within 48 to 72 hours after admission to hospital
Number of patients reporting pain to heath care personnel
Time frame: within 48 to 72 hours after admission to hospital
Proportion of physicians who know the patient is in pain according to the evolution in medical chart
Time frame: within 48 to 72 hours after admission to hospital
Number of nurses who know that the patient has pain according to medical chart
Time frame: within 48 to 72 hours after admission to hospital
Proportion of hospitalized patients treated for pain
Time frame: within 48 to 72 hours after admission to hospital
Type of analgesic treatment received
Time frame: within 48 to 72 hours after admission to hospital
Number of patients with pain evaluated by a pain specialist
Time frame: within 48 to 72 hours after admission to hospital
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 13 Aug 2019.
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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.
Diego Giunta, MD study director
Hospital Italiano de Buenos Aires
Maria L Bechelli, MD principal investigator
Hospital Italiano de Buenos Aires
Jimena Vicens, MD study chair
Hospital Italiano de Buenos Aires
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, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 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: finished, as of the sponsor's last update on 13 Aug 2019. 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 Argentina. 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?
Prevalence of pain (time frame: within 48 to 72 hours after admission to hospital). 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 13 Aug 2019.