Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain in a Low Resource Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- change of the intensity of perceived labor pain.
研究概览
简要总结
to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains
详细描述
investigators conducted a randomized clinical study included including 96 primiparous women admitted to Obstetrics and Gynecology Department, Menoufia University Hospitals, starting the study from May 2019 to March 2020 to assess the use of paracetamol intravenously versus Pethidine HCL intravenously in management of intrapartum pain. After obtaining approval from the local ethics committee, women who agreed to participate gave their signed informed consent after explanation of the trial benefits and hazards
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
- Single (Participant)
盲法说明
Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous
- •aged 18-35 years,
- •Term live singleton pregnancy,
- •Vertex presentation,
- •Spontaneous onset of labor at term 37-42 weeks gestation,
- •In active phase of of 1st stage of labour (cervix dilatation 3- 4 cm).
排除标准
- •Clinical evidence of cephalopelvic disproportion
- •Use of any kind of analgesia prior to study
- •Any medical disorder during pregnancy (liver or kidney impairment)
- •Induction of labor, Intrauterine fetal death
- •Evidence of fetal distress
- •Antenatal diagnosis of congenital malformation
- •Previous history of hypersensitivity to either drug
- •Extremes of age (i.e. below 18 or above 35)
- •Multiple pregnancies
- •Cervical dilatation more than 6 cm.
研究组 & 干预措施
paracetamol group
Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%].
干预措施: paracetamol-pethidine (Drug)
pethidine group
Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%].
干预措施: paracetamol-pethidine (Drug)
结局指标
主要结局
change of the intensity of perceived labor pain.
时间窗: immediately after the intervention and up to 3 hours after the intervension
Labour pain was semi-objectively assessed using the visual analogue scale (VAS). In this technique, the patient is shown a ten cm line which represent at one end no pain and the other worst pain, and the patient is asked to point on the line where her pain lies. This scale has the added advantage that the pain can be given a numerical value.
次要结局
- duration of the active phase of the 1st stage of labor(immediately from start of active phase of the 1st stage of labor till the end of first stage)
- maternal dizziness, nausea and/or vomiting(immediately after the intervention till the end of first stage)
- mode of delivery (vaginal or by caesarian(immediately after the intervention)
- Neonatal respiratory distress .(immediately after delivery of the fetus)
- duration of the 2nd stage of labor(immediately from start of second stage till deliver of fetus)
- need for further analgesia(immediately after the intervention till the end of first stage of labour)
- need for neonatal resuscitation(immediately after delivery of the fetus)
- need for NICU admission(immediately after delivery of the fetus)
- 1- and 5-minutes Apgar scores.(immediately after delivery of the fetus)
研究者
Mohamed Elsibai Anter
lecturer of obstetrics and gynecology
Menoufia University