Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients in the Federal Medical Center, Yenagoa, Bayelsa State, Southern Nigeria: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 166
- 主要终点
- To Evaluate the Number of Participants with Pain After 1 hour of Analgesia Administration
研究概览
简要总结
Labour is a very painful experience and epidural analgesia is considered the gold standard for pain relief in labour. Epidural scarcity, cost and shortage of skilled personnel to administer it is a limitation to it's usage in developing countries. Parenteral opioid analgesics such as pethidine and pentazocine are effective labour analgesia commonly used in developing countries but are limited by their side effects. This limitation in their use call for the need for alternative analgesic with similar or superior analgesic effect but with minimal side effects.The study is aimed at evaluating the efficacy and safety of combined tramadol and paracetamol in reducing labour pain among parturients.
详细描述
There is paucity of data in our environment looking at the efficacy and safety of combined tramadol and paracetamol in relieving labour pain. This study will offer us great opportunity to evaluate their synergistic effect in labour when compared to the commonly used single opioids such as pethidine or pentazocine.
It would be a double blinded randomized controlled trial. One hundred and sixty-six pregnant eligible women in labour would participate in this study. Participants will be randomized equally into two study arms ( Tramadol plus Paracetamol study arm and Pentazocine study arm) after informed consent. The Tramadol plus Paracetamol study arm will receive 100mg of tramadol plus 600mg of paracetamol intramuscularly in a 2ml and 5ml syringe respectively while the pentazocine study arm will receive 30mg of Pentazocine and 2 milliliters of water for injection as placebo intramuscularly in a 2l and 5 ml syringes respectively. Both drugs will be administered to the participants at 4-6cm cervical dilatation during labour. The outcome measures will be evaluated within 5 hours in labour and an hour immediately after delivery. The need for additional rescue analgesia will be assessed as well. Fetal outcome on both arms will be noted too.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The hospital Pharmacist will prepare the drugs in both arms where the first arm will be 2 ml of 100mg tramadol in 5 ml syringe and 2ml of 600mg Paracetamol in 5 ml syringe as well. The second arm will be 2ml of 30mg pentazocine in 5ml syringe plus 2ml of water for injection. Both arms of the medications will be pre-packed in opaque envelopes and labelled by the pharmacist as either A or B who will take no further part in the study. These will be assigned based on the randomized outcome. The randomization list will be on the possession of research assistant who will take no further part in the study after randomly assigning participants to the study arms till the end of the study.
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All pregnant women who presented in spontaneous labour at term, carrying Singleton Live Fetus in Active Phase of Labour with Cervical dilatation of 4-6cm who gave consent to participate in the study
排除标准
- •Women with severe medical conditions such as diabetes mellitus, severe pre-eclampsia, cardiac, liver and renal disease
- •Preterm Labour
- •Intrauterine Fetal Death
- •Fetal presentation other than cephalic
- •Patients with previous caeserean section
- •History of hypersensitivity to paracetamol, tramadol and pentazocine
- •Complications such as antepartum haemarrhage, polyhydramnious, premature rupture of membrane
- •Use of any kind of analgesia before recruitment
- •Multiple gestation
- •All other delivery except spontaneous vertex delivery Labour that was induced or augmented
研究组 & 干预措施
Tramadol plus Paracetamol
2ml of 100mg of intramuscular tramadol plus 2ml of 600mg of intramuscular paracetamol unlabeled
干预措施: Pentazocine plus placebo (Drug)
Pentazocine plus placebo
2ml of 30mg of pentazocine plus 2 ml of water for injection will be administered intramuscularly during labour
干预措施: Pentazocine plus placebo (Drug)
结局指标
主要结局
To Evaluate the Number of Participants with Pain After 1 hour of Analgesia Administration
时间窗: 1 hour post analgesia administration
Pain was Assessed during Labour 1 hour Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
To Evaluate the Number of Participants with Pain After 2 hours of Analgesia Administration
时间窗: 2 hours post analgesia administration
Pain was Assessed during Labour 2 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
Number of Participants with Treatment Related Adverse Events on both arms
时间窗: Time of first analgesia administration to 2 hours Post Delivery
Number of Participants with Treatment Related Adverse Events such as Nausea, Vomiting, Hypersensitivity Reaction, respiratory depression and any other Adverse Effects from the time of first administation to 2 hours post delivery
To Evaluate the Number of Participants with Pain After 3 hours of Analgesia Administration
时间窗: 3 hours post analgesia administration
Pain was Assessed during Labour 3 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
To Evaluate the Number of Participants with Pain 4 hours After Analgesia Administration
时间窗: 4 hours post analgesia administration
Pain was Assessed during Labour 4 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
To Evaluate the Number of Participants with Pain 5 hours After Analgesia Administration
时间窗: 5 hours post analgesia administration
Pain was Assessed during Labour 5 hours Post Analgesia Administration using the Numerical Rating Scale for Pain. The Numerical Rating Scale has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher score means a worse outcome (0=No Pain at all, 5 means Moderate Pain and 10= Worse pain imaginable)
次要结局
- Participants with Good Service Satisfaction(First 5 hours Post Delivery)
- Analgesia Administration to Delivery interval(First 2 hours Post Delivery)
- Apgar Scores of the Neonates(At first and fifth minutes after birth)
- Special Care Baby Unit Admissions(First 2 hours Post Delivery)
研究者
Andrew Orhorho
Principal Investigator
Federal Medical Centre, Yenagoa