Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04209764 |
| Other study ID # |
1744_OPBG_2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 6, 2022 |
| Est. completion date |
November 6, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Bambino Gesù Hospital and Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
