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临床试验/NCT00202722
NCT00202722已完成4 期

Remifentanil as Analgesia for Labour Pain

Sorlandet Hospital HF1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)

研究概览

简要总结

Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.

详细描述

Primary and secondary outcome measures presented under "results"

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

性别
Female
接受健康志愿者

入选标准

  • Healthy women (ASA I-II), in active labour, one fetus with no suspected pathology, expecting normal childbirth, informed consent.

排除标准

  • Failure to obtain informed consent, received opioids within last 8 hours before study start, serious side-effects mother and abnormal fetal heart rate.

研究组 & 干预措施

Remifentanil IVPCA

Active Comparator

Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time

干预措施: Remifentanil (Drug)

结局指标

主要结局

Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)

时间窗: From start with remifentanil treatment until delivery, up to 8 hours.

Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints.

次要结局

  • Patient Satisfaction(From start of remifentanil treatment until delivery)

研究者

发起方
Sorlandet Hospital HF
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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