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

Sponsor
Giuliano Marchetti (Other)
Overall Status
Recruiting
CT.gov ID
NCT04209764
Collaborator
Bambino Gesù Hospital and Research Institute (Other)
90
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1
88.4

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalenza Del Dolore Nei Dipartimenti di Chirurgia ed Oncoematologia
    Anticipated Study Start Date :
    Oct 30, 2021
    Anticipated Primary Completion Date :
    Nov 29, 2021
    Anticipated Study Completion Date :
    Nov 30, 2021

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    All the patients in the Ward

    Exclusion Criteria:

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BambinoGHRI Roma Lazio Italy 00165

    Sponsors and Collaborators

    • Giuliano Marchetti
    • Bambino Gesù Hospital and Research Institute

    Investigators

    • Principal Investigator: Giuliano MD Marchetti, Staff, Bambino Gesù Hospital and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Giuliano Marchetti, Principal Investigator, Bambino Gesù Hospital and Research Institute
    ClinicalTrials.gov Identifier:
    NCT04209764
    Other Study ID Numbers:
    • 1744_OPBG_2019
    First Posted:
    Dec 24, 2019
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2021