Clinical trial NCT04209764: Prevalence of Pain in the Departments of Surgery and Oncoematology of a Children's Hospital
Official title: Prevalenza Del Dolore Nei Dipartimenti di Chirurgia ed Oncoematologia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Chronic Pain Syndrome
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Bambino Gesù Hospital and Research Institute
First posted: 2019-12-24
Enrollment: 63
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children

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.

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.

Eligibility criteria: Inclusion Criteria:

All the patients in the Ward

Exclusion Criteria:

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

Primary outcomes:
measure: Pain in Children: Numbers of patients at the time of interview and twenty four hours before
timeFrame: Forty minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: BambinoGHRI
state: Lazio
Study officials:
affiliation: Bambino Gesù Hospital and Research Institute
name: Giuliano MD Marchetti, Staff
role: PRINCIPAL_INVESTIGATOR
References: