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Pain, PostoperativeNCT04209764

Prevalence of Pain in the Departments of Surgery and Oncoematology of a Children's Hospital

An observational study of Pain, Postoperative and Chronic Pain Syndrome, run by Giuliano Marchetti at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Six years after, the authors will conduct the same analysis to check if there have been any improvements in the management of analgesic therapy after the measures taken according to the results of the previous study conducted in the same departments. Read more about this study

Who is it for?
Ages 1 day to 18 years
Conditions the study is for
Pain, Postoperative, Chronic Pain Syndrome
How many people
63 participants
Where
1 siteItaly
Study dates
6 Nov 2022to 6 Nov 2022
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 1 day to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Children

Who may be able to join

  • All the patients in the Ward

Who cannot join

  • Patient that are not in the ward at the time of the study

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • BambinoGHRI

    Rome, Lazio, 00165

Other trials in Italy

About this study

Official title: Prevalenza Del Dolore Nei Dipartimenti di Chirurgia ed Oncoematologia

Six years after, the authors will conduct the same analysis to check if there have been any improvements in the management of analgesic therapy after the measures taken according to the results of the previous study conducted in the same departments.

During a single day work three committees, administering a questionnaire to patients or parents, will evaluate the adherence to international recommendations (JCI and WHO) in the management of analgesic therapy.

Read the detailed description

Thi is a cross sectional study selecting a specific interval (from 8:30 to 17:30) within a single working day of the week, to have a snapshot of the pain experience in a typical working day of the involved departments. The survey will carried out by two pairs of investigators made up of a doctor (possibly Anesthesiologist) and a nurse, not involved in the care of the patient, assigned to hand out a questionnaire-data collection to hospitalized patients or to their parents. Prior informed consent will be obtained by the doctor from parents or from patients more than six years old with the permission of their parents. They will sign a pre-printed paper form specifically formulated for individual ages. For patients and families with inability to understand Italian an interpreter will be used. Only the patients present in the two departments at the time of visit will be included in the study. The two committees will evaluate the adherence to international recommendations (JCI, WHO) in the management of pain treatment, pointing out the prevalence of pain, its intensity and pain therapy prescribed. When necessary, medical records will be consulted in order to verify the "pain history" in the hospital for individual patient and the appropriateness of analgesic administration respecting the intensity of pain experienced. Recorded data will be: 1) patient demographics (age sex, weight, presence of language barriers or cognitive deficits); 2) prevalence and intensity of moderate and/or severe pain during hospitalization, 24 hours before the interview, and at the time of the interview; 3) the type of analgesic administered, the way, the duration and frequency of administration of drugs; 4) the Pain Management Index (PMI) as suggested by Strohbuecker et al and modified for use in children. PMI compares the analgesic drug with the level of pain reported by the patient and is computed by subtracting pain scores from analgesic scores. The analgesics will be scored as follows: no analgesic: 0 points, WHO I: 1 point, WHO II: 2 points, WHO III: 3 points. We defined and scored pain levels of NRS and FLACC 0: no pain (0 points) NRS and FLACC 1-3: mild pain (1 point),.NRS and FLACC 4-6: moderate pain (2 points) and NRS and FLACC 7-10: severe pain (3 points). The PMI ranges from -3 (patients with severe pain receiving no drug at all) to +3 (patients receiving strong opioids and reporting complete pain relief), negative scores indicate undertreatment. For statistical analysis will be used a descriptive analysis using the minimum values, maximum values, averages and standard deviations.

Medical subject headings
Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain in Children: Numbers of patients at the time of interview and twenty four hours before

    Numbers of patients at the time of interview and twenty four hours before

    Measured: Forty minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2019
  2. Study start6 Nov 2022
  3. Primary completion6 Nov 2022
  4. Study completion6 Nov 2022

Resources

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04209764
Sponsor's protocol ID
1744_OPBG_2019
Status last verified
Nov 2022
First submitted
16 Dec 2019
Last updated
8 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Marchetti G, Vittori A, Cascella M, Mascilini I, Piga S, Petrucci E, Castellano A, Caruso R, Francia E, Stocchi F, Marinangeli F, Inserra A, Picardo SG. Pain prevalence and pain management in children and adolescents in an italian third level pediatric hospital: a cross-sectional study. Ital J Pediatr. 2023 Mar 29;49(1):41. doi: 10.1186/s13052-023-01439-2.

    PubMed 36978099

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, Postoperative and Chronic Pain Syndrome, run by Giuliano Marchetti at 1 site in Italy.

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 1 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 8 Nov 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 Italy. 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 in Children: Numbers of patients at the time of interview and twenty four hours before (time frame: Forty minutes). 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 NCT04209764, which also lists 1 linked publication.

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 8 Nov 2022.

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Clinical Trial NCT04209764 | AzTrials