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临床试验/NCT03420911
NCT03420911已完成不适用

Determination of the Effects of Change in Anxiety Level on Pain Perception in Patients Who Present to Emergency Department Due to Acute Pain: a Double Blind, Randomized, Controlled Trial

Derince Training and Research Hospital0 个研究点目标入组 180 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
主要终点
the change in pain levels

研究概览

简要总结

The aim of this study is to determine the level of pain and anxiety in patients who present to the emergency department with acute pain, and to investigate the effect of the standard analgesic treatment and an additional anxiolytic treatment on pain and anxiety.

详细描述

After triage, each acute pain patient who qualified for the study was asked for consent. Written informed consent was obtained from all patients who were eligible for the study. After obtaining written informed consent, demographic and clinical data were collected and recorded by the attending physician. Our study consisted of two parallel groups. Participants were randomly assigned into two groups with a 1:1 allocation following simple randomization procedures by a program generating an online random number. The control group was given only the analgesic drug dexketoprofen trometamol and the study group was given analgesic plus anxiolytic, the same dose of dexketoprofen trometamol plus midazolam . Both groups received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg, and the midazolam dose was 1 mg. The study was double-blind. Sequenced study medications were prepared by a nurse, and another nurse administered the medications. In patients with an insufficient improvement of pain after 60 minutes, fentanyl 1 mcg/kg ı.v. was administered as a rescue medication.

Pain and anxiety in patients was measured at 0, 30, 60 and 120 minutes using the standard 100 mm horizontal visual analogue scale (VAS). The patient's general anxiety states were measured with the Turkish adopted version of the Hospital Anxiety and Depression Scale (HADS). Patients who have greater than 10 points are assumed anxious (9). The HADS and VAS scores were measured and recorded to the database by the researcher. At the time of discharge, patient satisfaction with treatment was evaluated by asking two questions with the 5-step Likert scale. The questions were, "I am satisfied with the applied treatment", and "I would like the same treatment applied again". Patient answers were, "1-I strongly disagree", "2-I disagree", "3-I am not sure", "4-I agree", and "5-I strongly agree".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Sequenced study medications were prepared by a nurse, and another nurse administered the medications.

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

  • The patients who presented to the emergency department with acute pain
  • Who accepted to include the study
  • Who were older than 18 years old

排除标准

  • Patients who refused to participate to the study
  • History of allergy to any of the study drugs
  • Pregnancy
  • Younger than 18 years old
  • Chronic pain
  • Antidepressant or anxiolytic drug use
  • Advanced kidney or liver failure
  • Use of analgesics within 6 hours before presentation

研究组 & 干预措施

dexketoprofen trometamol group

Active Comparator

Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg

干预措施: dexketoprofen trometamol (Drug)

dexketoprofen trometamol plus midazolam group

Active Comparator

Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg and the midazolam dose was 1 mg.

干预措施: dexketoprofen trometamol (Drug)

dexketoprofen trometamol plus midazolam group

Active Comparator

Received the study drugs in 100 mL of normal saline within 5 minutes. The dexketoprofen trometamol dose was 50 mg and the midazolam dose was 1 mg.

干预措施: Midazolam (Drug)

结局指标

主要结局

the change in pain levels

时间窗: 30 minutes

the change in pain levels between groups on the 100mm visual analogue scale at 0-30th minutes

the change in anxiety levels

时间窗: 30 minutes

the change in anxiety levels between groups on the 100mm visual analogue scale at 0-30th minutes

次要结局

  • the need for rescue treatment(120 minutes)
  • the rate of the request for the same treatment(120 minutes)
  • the comparison of the pain and anxiety change on the visual analogue scale(120 minutes)

研究者

发起方
Derince Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ASIM ENES ÖZBEK

Principal Investigator

Derince Training and Research Hospital

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