Pain and Medical Abortion - Predicting Factors of Pain and Optimal Pain Management Among Teenaged Women Compared to Adult Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Patients are less painful using patient controlled analgesia (PCA)
研究概览
简要总结
In this two-parted study the need and sufficiency of analgesics and experienced pain is compared between teen-aged and adult women undergoing medical termination of pregnancy (MToP)in early pregnancy (under 9weeks of gestation). During MToP at pregnancy weeks 9-20 on-demand administration of opiates and patient-controlled analgesia (PCA) are compared in randomized clinical trial.
详细描述
Adequate pain control is crucial in medical abortion. Experience of painful and traumatic abortion can affect patients future plans on pregnancy and childbirth. Study's purpose is to investigate only pain experience and pain management. Otherwise the care of abortion is according to present Finnish national guideline.
Study's goal is to evaluate experienced pain and the need and adequacy of analgesics and to obtain more efficient analgesics during MToP. In addition investigators hope to recognize predicting factors of severe pain.
Study is done in cooperation with Helsinki university and Helsinki university central hospital and is accomplished in Womens hospital and Kätilöopisto hospital in which care of abortions is centralized in HUS area.
Altogether 340 women, who are primigravid, aged between 15-19 or 25-35 years and tolerate used analgesics, are recruited in the study. MToP is done with the combination on mifepristone 200mg and misoprostol 800ug according to Finnish national guidelines. Baseline analgesics are Ibuprofein 600mg ja Paracetamol 1000mg, both three times a day and first dose is taken simultaneously with Misoprostol.
First part is a prospective study in which we compare pain experience and sufficiency of analgesics during MToP in early pregnancy (under 9 weeks of pregnancy). Pain is measured by VAS, which is reported in a diary every time analgesics are needed.
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
- None
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who choose medical method of abortion
- •First pregnancy
- •Age between 15 and 19 years or 25 and 35 years
- •Patients volunteer in the study
- •Exclusion criteria for inquiry part are
- •Patient's serious illness
- •Known allergy to one of the trial medications
- •Abortion is done based on foetal abnormality or threat of patient's own health
- •Exclusion criteria for intervention part are
- •Abortion is done based on foetal abnormality or threat of patient's own health
- •Minor patient does not want to inform guardian
- •More than one foetus
- •Patient's serious illness (ASA-class 3 or 4)
- •Massive obesity (BMI >35 kg/m2)
- •Known allergy to one of the trial medications
- •History of opioid abuse
- •Problems of understanding (Inability of use PCA or to understand VAS)
- •Active bleeding before intake of first Misoprostol dose
- •One of next medications: ketokonatsol, erythromycin, claritromycin, verapamil or diltiazem or medication against HIV (CYP3A4-transmitted interaction with oxycodon)
排除标准
- 未提供
研究组 & 干预措施
Patient controlled analgesia (PCA)
Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day.
Patients get pain medication (Oxynorm) via PCA
干预措施: Oxynorm via PCA (Drug)
Oxynorm on-demand
Pregnancy weeks 9-20. All patients get baselineanalgesics: Ibuprofein 600mg and Paracetamol 1000mg both x3 a day.
Patients get extra pain medication (Oxynorm) on-demad from the nurse.
干预措施: Oxynorm on-demand (Drug)
结局指标
主要结局
Patients are less painful using patient controlled analgesia (PCA)
时间窗: During drug-induced abortion, in hospital care (1-2days)
Measured in visual analog scale (VAS, 0-100mm). VAS is lower.
次要结局
- Patient satisfaction is higher(just after the abortion and 2-3 weeks after in follow-up visit)
研究者
Venla Kemppainen
MD
Helsinki University Central Hospital