Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Intra-operative pain assessment was based on changes in each five minutes interval in heart rate
研究概览
简要总结
Objective of study:
To compare the efficacy of intravenous paracetamol and fentanyl for intra-operative and post-operative pain relief in patients undergoing diagnostic and therapeutic hysteroscopy.
Hypothesis of study:
There is no difference in pain control between intravenous fentanyl and paracetamol in patients undergoing hysteroscopy.
详细描述
Intraoperative pain assessment will be based on:
Hemodynamic vital (SBP, DBP. MAP and HR) increase 20% from the baseline will be observed and assumed pain.
Postoperative pain assessment will be based on:
Mean Pain score :Visual analogue pain scale (VAS) of 0-10 cms will be used to assess the pain at the end of the procedure.
Diagnostic hysteroscopy:
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective surgery
- •American Society of Anaesthesiologists (ASA) grade I & II
排除标准
- •Patients with anticipated difficult airway
- •Gastro-oesophageal reflux disorder
- •Body mass index (BMI) >30kg/m2
- •Known Hepatic disorder
- •Known ischemic heart disease
- •History of hypersensitivity reactions to paracetamol and fentanyl or already taking paracetamol and fentanyl
- •Patient experiencing the iatrogenic intra-operative uterine perforation
研究组 & 干预措施
Paracetamol group-P
Paracetamol 15mg/Kg was dministered 30 minutes before the start of surgery
干预措施: paracetamol, the group P (Drug)
Fentanyl group-F
Fentanyl 2mcg/kg was administered at the time induction of anaesthesia
干预措施: fentanyl, group-F administered as an active comparator (Drug)
结局指标
主要结局
Intra-operative pain assessment was based on changes in each five minutes interval in heart rate
时间窗: Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure
To assess the intra-operative pain by changes in hemodynamic parameters such as heart rate rising from the 20 percent of the baseline value were considered that the patient is experiencing pain
Post-operative pain assessed by using the visual analogue pain scale (VAS): 15 minutes after anaesthesia
时间窗: 15 minutes post-anaesthesia
To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit. Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10
Intra-operative pain assessment was based on the changes at each five minutes interval in systolic and diastolic blood pressure
时间窗: Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure
To assess the intra-operative pain by changes in hemodynamic parameters such as systolic blood pressure, diastolic blood pressure rising from the 20 percent of baseline value were considered that the patient is experiencing pain
Intra-operative pain assessment was based on changes in each five minutes interval in mean arterial blood pressure
时间窗: Time frame was zero to 2 hours and data recordings were at 5 minutes interval from start from the surgical stimulation till the completion of the surgical procedure
To assess the intra-operative pain by changes in hemodynamic parameters such as mean arterial blood pressure rising from the 20 percent of baseline value were considered that the patient is experiencing pain
Post-operative pain assessed by using the visual analogue pain scale (VAS): 30 minutes after anaesthesia
时间窗: 30 minutes post-anaesthesia
To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit. Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10
Post-operative pain assessed by using the visual analogue pain scale (VAS): Immediately after anaesthesia
时间窗: Immediately post-anaesthesia
To assess the postoperative pain by using the visual analogue pain scale (VAS) by using the scale in numbers from 0-10 cm in post anesthesia care unit. Note: Mild pain was considered score from 0 to 3, Moderate pain was labelled the score from 4 to 6 and Severe pain was considered the score from 7 to 10
次要结局
未报告次要终点
研究者
Dileep Kumar
Assistant Professor
Aga Khan University