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临床试验/NCT04209764
NCT04209764已完成不适用

Prevalenza Del Dolore Nei Dipartimenti di Chirurgia ed Oncoematologia

Giuliano Marchetti1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2022年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Pain in Children: Numbers of patients at the time of interview and twenty four hours before

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All the patients in the Ward

排除标准

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

结局指标

主要结局

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

时间窗: Forty minutes

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

次要结局

未报告次要终点

研究者

发起方
Giuliano Marchetti
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Giuliano Marchetti

Principal Investigator

Bambino Gesù Hospital and Research Institute

研究点 (1)

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