Comparative Study Of Safety And Efficacy Of Intravenous Paracetamol Versus Intramuscular Tramadol As Labour Analgesic
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To check the efficacy of intravenous paracetamol with intramuscular tramadol when used as labor analgesics
研究概览
简要总结
All women in early/active labor after admission will be explained about the study and the type of drugs being used. Consenting pregnant women will be divided into two groups by alternate methods. When the enrolled woman goes into active phase of labor with cervical dilatation ≥ 4cm,with cervical effacement of 60% ,she will be administered Visual Analogue Scale for pain scoring, then she will be given either one of the following study drugs:
• 100 ml of 1 gram inj paracetamol single dose given over 10 minutes
•100mg of inj tramadol hydrochloride single dose IM given over 15 mins.
•Visual Analogue scale (VAS) will be used to assess pain intensity and will be recorded in register.
•Pain in both groups will be analyzed at 10 mins, 30 mins and then hourly after drug administration. If VAS >6 at any time, additional analgesic will be added .
Labor will be monitored using a WHO modified partograph and termination of pregnancy will be as per standard. Fetal monitoring will be done using a electronic fetal monitor.
Mothers will monitored for 24 hours after delivery for any side-effects and Neonatal conditions will be assessed by the use of APGAR scoring system and the need for admission into the NICU
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Consenting women in early/active phase of labour at ≥37weeks gestation Singleton pregnancy with cephalic presentation.
排除标准
- •Multiple Pregnancy and mal-presentation Intrauterine fetal death Women who do not consent for the study.
- •<37 weeks period of gestation History of allergy to any of the study drugs.
结局指标
主要结局
To check the efficacy of intravenous paracetamol with intramuscular tramadol when used as labor analgesics
时间窗: 10 mins | 30mins | 1 hourly after the administration of drug
次要结局
- To check the safety of injection paracetamol with injection tramadol when used as labor analgesics(0hrs to 24 hrs after delivery)