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临床试验/NCT03135470
NCT03135470终止不适用

Adequacy and Adverse Effects of Pain Medication After Ambulatory Surgery, Observational Study

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2017年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
146
试验地点
1
主要终点
Medication

研究概览

简要总结

In Finland, there are no guidelines concerning post-operative pain medication of ambulatory surgery patients. There is a wide variety in drug prescription and medication practices of various doctors and clinics. To treat patients' pain safely, type of surgery, unique patient needs, risks, adverse effects and patient's capacity to follow instructions should be assessed during the few hour visit at the clinic. In many clinics, pain is treated after hospital discharge with strong opioid oxycodone, but the amount and dose of prescribed oxycodone varies. In Helsinki Universitys Hospital, Peijas Hospital, investigators have over 2000 ambulatory surgery procedures annually. Investigators have strict policy in oxycodone use after patient discharge compared to some other Finnish ambulatory surgery clinics. The aim of this study is to evaluate, whether the prescribed pain medication is sufficient and whether patients' suffer from adverse effects after discharge from ambulatory surgery (letter interview). The study proceeds in three phases: 1) observation of current medication practice, 2) observation after optimization and standardization of hospitals drug prescription protocol, 3) evaluation of mobile phone app in pain medication follow up.

详细描述

After informed consent, all patients operated as ambulatory surgery patients during the study period are given a letter interview for pain, pain medication and symptom follow up. They are also given a return envelope (with paid postal fee) to return the interview.

Based on the results of the first interview phase, our pain medication practice is reconsidered by anesthetists and surgeons to create a standard operating protocol for pain medication. The standard operating protocol is informed to personnel. Then, patient interview phase is repeated for another 3 months.

Then, investigators continue with a pilot study on using a mobile phone app in evaluating patients pain, sufficient pain medication and adverse effects. All patient with informed consent, suitable mobile phone, and willing to use it for reporting pain for hospital personnel are contacted via the mobile app. Other patients operated during that study period are interviewed by either letter interview or phone interview. Investigators try to estimate whether mobile apps are suitable for pain and medication follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All plenipotentiary patients, operated as ambulatory surgery patients in our clinic during the study period, with informed consent

排除标准

  • We do not accept patients, who are not plenipotentiary (minor, incompetent, prisoners, conscript in military service) or do not understand finnish or swedish written information

结局指标

主要结局

Medication

时间窗: up to two days after surgery

all pain medication used (reported By the patient)

Pain

时间窗: up to two days after surgery

Pain assessed By the patient By numerical rating scale 0-10

Adverse effects

时间窗: up to two days after surgery

Adverse effects of the pain medication, study questions

Sufficiency of pain medication

时间窗: up to two days after surgery

Whether the pain medication used was sufficient or not, study questions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noora Skants

MD/PhD, Specialist in anesthesiology and intensive care

Helsinki University Central Hospital

研究点 (1)

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