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临床试验/NCT03105830
NCT03105830Unknown不适用

Pain Management Efficiency at Latent Period of Labour

Western Galilee Hospital-Nahariya0 个研究点目标入组 150 人开始时间: 2017年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
主要终点
pain score

研究概览

简要总结

Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor.

Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug in blood

详细描述

Maternity are latent or first stage of labor and complained of pain at the level of 4 or higher on a scale VAS, and are not in risk (HIGH RISK). And did not receive analgesics within 4 hours.

The sample will consist of at least 100 women in labor.

  1. women, will be identified in the reception room of a delivery room by midwives.
  2. The research team will ask for consent after receiving an explanation and confirmation of understanding.
  3. The midwife will perform and will record pain assessment by visual analog scores .
  4. Maternity reported pain level 4 and above will be asked four questions out of data collection and offered them treatment I.V. PARACETAMOL 1gr as directed by the physician.
  5. After giving I.V. PARACETAMOL 1g, carried out and documented estimate of the pain returns (by visual analog scores) after an hour wait at any time to wait four hours and two hours after birth.

In cases of an outbreak of pain can give one of the following:

Option A:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • latent phase of labour

排除标准

  • high risk
  • allergy to paracetamol
  • liver insufficiency

研究组 & 干预措施

intervention and data collection

Experimental

pain management by iv paracetamol

干预措施: iv paracetamol (Drug)

结局指标

主要结局

pain score

时间窗: pain assessmant by vas scale during the latent phase of labor at delivery room. the data will be presented through study completion, an average of 1 year

vas

次要结局

  • level of paracetamol(at the end of labor , blood samples from the mother and from the umbelical cord. the data will be presented through study completion, an average of 1 year)
  • pain experience(72 hours after labor , the data will be presented through study completion, an average of 1 year)
  • pain influences(72 hours after labor, the data will be presented through study completion, an average of 1 year)
  • pain experience and analgesia(72 hours after labor, the data will be presented through study completion, an average of 1 year)

研究者

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

Oleg Shnaider

head of delivery room

Western Galilee Hospital-Nahariya

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