PCA Ketamine-Morphine Versus PCA Morphine as Post-Operative Analgesia in Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of PCA ketamine-morphine versus conventional PCA morphine in postoperative patients undergoing elective laparotomy colorectal surgery under general anaesthesia. The specific objectives are:
- To compare the post-operative analgesic requirement with PCA ketamine-morphine in comparison with PCA morphine.
- To compare the postoperative pain scores between PCA ketamine-morphine and PCA morphine.
- To assess patients' overall satisfaction with PCA ketamine-morphine in comparison with PCA morphine.
- To study the incidence of side effects of PCA ketamine-morphine in comparison with PCA morphine.
Participants will be screened and recruited at pre-anaesthetic clinic (PAC). Those who consented will be taught to use PCA machine and the potential side effects of the study drugs. They will be randomly allocated into either Group A or Group B by computer generated randomization a day before planned surgery.
Researchers will compare Group A and Group B to see post-operative pain scores, patients' overall satisfaction and any incidence of side effects.
详细描述
INTRODUCTION
Patient-controlled analgesia (PCA) is an established, efficient and safe technique for providing postoperative analgesia and has been associated with better pain relief and patient satisfaction with less postoperative complications and side effects [1]. Despite years of advances in pain management, opioids have been the mainstay for treatment of postoperative pain particularly in moderate to severe pain. Of all opioids, morphine is the most studied drug and remains the drug of choice for PCA, especially in Malaysian hospitals. However, morphine usage is also associated with known side effects such as sedation, nausea and vomiting, pruritus, urinary retention and respiratory depression [2]. A review of 32 studies involving opioids-based PCA-22 of which were PCA morphine-reported an incidence of 19% nausea, 18.1% vomiting, 30.9 % of nausea and/or vomiting, 25.7% sedation, 17.9% urinary retention, 17.9% pruritus and 15.2% hypoxia and 1.6% respiratory depression that may be life-threatening associated with PCA opioids use [3, 4]. The concept of multimodal analgesia hence was introduced to reduce opioid-related side effects. Adjuvants such as acetaminophen and non-steroidal anti-inflammatory drugs are commonly used nowadays in combination with opioids as opioid-sparing agents to reduce opioid usage [5].
Ketamine, an N-methyl-D-aspartate (NMDA) antagonist, has undergone a recent resurgence of interest among acute care providers as an adjunct in acute pain management [6, 7]. Ketamine at a sub-anesthetic dose (0.2-0.5 mg kg-1) produces intense analgesia [5, 8]. Since its development in 1962, various studies have been conducted to prove the efficacy of ketamine as post-operative analgesia and as an opioid-sparing agent [8-10]. A review by Laskowski and colleagues described that IV ketamine improved the quality of pain control, in addition to decreased opioid consumption with the particular benefit being observed in painful procedures, such as upper abdominal, thoracic, and major orthopedic surgeries [11]. While Carstensen and co-workers in a qualitative review comparing PCA ketamine-morphine with PCA morphine alone also described the superior efficacy of ketamine-morphine in providing pain control with a significantly higher incidence of opioid-related side effects in the morphine group [12]. In comparison to opioids, ketamine's lack of respiratory depressant effects also favors its use as an opioid adjunct in patients with airway and respiratory compromise, especially in morbid obesity and post-thoracotomy patients [13, 14].
Despite the potential efficacy with published evidence of PCA ketamine-morphine in postoperative pain management, its use is not well established in most Malaysian hospitals including the current study site. Hence, the aim of this study was to evaluate the effectiveness of PCA ketamine-morphine in comparison to conventional PCA morphine alone as postoperative analgesia in colorectal surgery patients in the current study site.
METHODS
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The patients, nurses who cared for the patients, the anesthetist who performed the anesthesia and the investigators who gathered the data were blinded to patients' group allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective American Society of Anaesthesiologists (ASA) I or II patients scheduled for lower midline laparotomy colorectal surgery aged between 18-70 years old
排除标准
- •Patients with a known allergy to morphine or ketamine, uncontrolled hypertension, past history of chronic pain on regular analgesics, psychiatric illness on psychiatric drugs, BMI more than 35 and creatine clearance less than 30.
研究组 & 干预措施
Group A
PCA ketamine (Ketamine HCl, Pfizer Inc., US) 0.5 mg plus morphine 0.5 mg ml-1 (ratio 1:1) as postoperative analgesia.
干预措施: Ketamine-Morphine (Drug)
Group B
PCA morphine (Pfizer Inc., US) 1 mg ml-1 as postoperative analgesia.
干预措施: Morphine (Drug)
结局指标
主要结局
Pain score
时间窗: 30 minutes after commencement of PCA until 48 hours
Pain score at rest and on movement with NRS Numerical Rating Scale (NRS) for pain score assessment A numerical pain assessment tool from 0 to 10, where 0 denotes no pain, 5 denotes moderate pain and 10 denotes worst possible pain.
Incidence of side effects
时间窗: 30 minutes after commencement of PCA until 48 hours
* Opiod related side effects : nausea and vomiting, pruritus, dizziness, respiratory depression and treatment on PRN basis if indicated * Ketamine related side effects : delirium, hallucinations, hypertension, tachycardia
PCA drugs demanded and delivered
时间窗: 30 minutes after commencement of PCA until 48 hours
Total PCA drugs demanded and delivered
Patients' overall satisfaction
时间窗: At 48 hours post oeprative
Assessment of patients' overall satisfaction with a 5-points scales at 48 hours. A 5-point scale from 1 to 5, where: 1. = very unsatisfied 2. = unsatisfied 3. = neutral 4. = satisfied 5. = very satisfied
次要结局
未报告次要终点
