Efficacy of Intravenous Tenoxicam as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale
研究概览
简要总结
The aim of this study is to assess whether tenoxicam is as effective as pethidine for analgesia during the first stage of labor.
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)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparity
- •Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
- •Maternal age between 20-30 years
- •Singleton term pregnancy (37-42 weeks of gestation)
- •Vertex-presenting fetus
排除标准
- •Clinical evidence of cephalopelvic disproportion
- •Scarred uterus; previous cesarean section, hysterotomy or myomectomy
- •Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment
- •Fetal distress
- •Receiving any regional or parenteral analgesia before recruitment in the study
- •Known hypersensitivity to the drug family
研究组 & 干预措施
Tenoxicam
Intravenous administration of tenoxicam, a lyophilisate with 20 mg to be dissolved and diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.
干预措施: Tenoxicam (Drug)
Pethidine
Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.
干预措施: Pethidine (Drug)
结局指标
主要结局
The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale
时间窗: 4 hours
Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 \[no pain\] to 10 \[worst possible pain\].
次要结局
未报告次要终点
研究者
Hamdy Bakry Mohye Soliman El Kinawy
TA
Ain Shams Maternity Hospital