Comparison of intravenous Paracetamol versus intravenous Tramadol for analgesia in labour
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- VISUAL ANALOGUE SCALE score
研究概览
简要总结
INTRODUCTION- Labour analgesia is an essential part of good obstetric care. Though labour pain is not life threatening, it can have neuropshychological consequences.Tramadol inhibits serotonin and norepinephrine uptake and enhance the inhibitory effects of pain transmission in the spinal cord. Tramadol and its metabolites are mainly excreted via the kidneys. Pracetamol is an effective analgesic with tolerable side effects. The use of intravenous formulation during labour for pain relief is advantageous with improved bioavailability and earlier onset of action. Its plasma half life is about 2.7 hours.
AIMS AND OBJECTIVES- To provide labour analgesia in form of intravenous Paracetamol and Tramadol during active stage of labour with following objectives-
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To study the safety and efficacy of intravenous Pararcetamol and Tramadol for labour analgesia
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Comparison of intravenous paracetamol and tramadol for labour analgesia
PROCEDURE TO BE DONE- To 125 women 100ml of Pracetamol will be given intravenously over 15 minutes and to 125 women 100ml of Tramadol will be given intravenously over 15 minutes and grading of labour analgesia will be recorded by Visual analogue scale score (VAS) between 0 and 10 ( 0= no pain and 10= most severe pain) at time of intervention and at 1/2 hour ,1 hour, 2 hour and 4 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primigravid and multigravid women of age ranges from 18 to 35 years with low risk to both mother and fetus (single live fetus in cephalic presentation without any associated obstetric and medical complication)
- •Women with gestational age ranges from 37 to 42 weeks
- •Women in active stage of labour (with cervical dilatation of 3-5 cm and with moderate intensity uterine contractions of 2-3 per 10 minutes each lasting for 30-45 seconds with good inter relaxation period in between), whether spontaneous or induced labour
- •Women with reactive Non Stress Test (NST) before recruitment into study
- •Women seeking labour analgesia.
排除标准
- •Women with high risk pregnancy like severe Intrauterine growth retardation (IUGR), multiple gestation, malpresentation, polyhydroamnios, oligohydroamnios, pre-mature rupture of membranes
- •Women with any medical disorder with pregnancy like severe anaemia, hypertensive disorders, diabetes mellitus, hypothyroidism
- •Women with scarred uterus
- •Women with obstetric indication for Lower Segment Caesarean Section before recruitment to study
- •Women in advanced stage of labour if cervical dilatation more than 5 cm
- •Women with use of any other kind of analgesia before recruitment to study
- •Women with previous history of hypersensitivity to Tramadol or Paracetamol
- •Women with deranged liver function test 9.
结局指标
主要结局
VISUAL ANALOGUE SCALE score
时间窗: At 0, 1/2, 1, 2 and 4 hours
次要结局
- Duration of active phase of labour(After delivery)
- Duration of labour analgesia(At 0, 1/2, 1, 2 and 4 hours)
- Mode of delivery(After delivery)
- Demographic Profile of patients(At 0 hour)
- APGAR SCORE(At 1 and 5 minutes)
- Effect on progress of labour(At 0, 1/2, 1, 2 and 4 hours)
- Effect on fetus during labour(At 0, 1/2, 1, 2 and 4 hours)