Intravenous butorphanol versus intravenous tramadol in patients operated for breast cancer- a randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To compare the incidence of PONV in patients operated for breast surgery receiving either Butorphanol or Tramadol in the immediate post-operative period
研究概览
简要总结
Tramadol is oft used analgesic in our setup to provide analgesia for patients in the perioperative period, but the incidence of nausea and vomiting is high. Butorphanol is an agonist-antagonist, which has shown to provide effective analgesia in the operative period with lesser incidences of nausea and vomiting when used epidurally. However, literature is limited regarding intravenous use of butorphanol. Hence, we propose to compare equianalgesic doses of Intravenous Butorphanol and intravenous tramadol in patients operated for breast cancer with respect to adverse effects like nausea, vomiting and sedation and analgesic efficacy by noting the time taken for the first rescue analgesic dose.
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 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age greater than 18 years and less than 65 years.
- •ASA status I and II 3)Elective unilateral breast surgeries [simple mastectomy with axillary clearance (SMAC),Modified radical mastectomy (MRM), breast conserving therapy (BCT) and oncoplasty].
排除标准
- •Patients taking opioids on a regular basis/ opioid abuser.
- •Patients allergic to any of the following drugs- tramadol, butorphanol, paracetamol, diclofenac.
- •Patients on anti-epileptics, anti-depressants, anti-psychotics, and warfarin.
- •Patient complaining of nausea/vomiting prior to surgery. (PONV score 1 or more)
- •History of motion sickness/ vertigo/ Inner ear disease
- •BMI > 30 or Weight < 45kgs
- •Patient or patient’s relatives unable to understand the language employed for counselling
- •Non-consenting patient.
- •pregnant/nursing mothers. Immediate post-operative exclusion criteria a)Patients having severe pain [numerical rating scale (NRS)>7] in the immediate post-operative period in recovery room (RR) and requiring immediate dose of fentanyl and patients having no pain[numerical rating scale.
- •0]. b)Patients with vomiting post extubation or in the recovery before administration of the study drug. c)Intra operative complications which might warrant the patient to remain intubated in the immediate post-operative period.
结局指标
主要结局
To compare the incidence of PONV in patients operated for breast surgery receiving either Butorphanol or Tramadol in the immediate post-operative period
时间窗: 1 , 1.5, 2, 4 to 6 and 12 to 20 hours after giving butorphanol or tramadol
次要结局
- 1)to compare analgesic efficacy of butorphanol and tramadol with respect to reduction in pain scores and time to first rescue analgesic.(2) to compare incidence of other adverse effects including number of episodes of vomiting, sedation, respiratory depression, psychomimetic effects.)