Evaluation of Paracetamol as Post-operative Analgetic Modality Compared With Ketorolac
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Pain change
研究概览
简要总结
Post-operative analgetic modalities vary between center to center, especially in Indonesia. Considerations include potency/effectivity of the analgetics to achieve adequate pain control as soon as possible, reducing the total opioid dose intake and overall reducing potential opioid adverse effects. NSAID have been known to have more adverse effects than acetaminophen (paracetamol) but offers a higher potency for analgetic effects. Here the investigators compare whether paracetamol is adequate as a post-operative analgetics and confers fewer overall adverse effects when compared with ketorolac (NSAID)
详细描述
OBJECTIVE: The purpose of this study was to compare the efficacy of Ketorolac versus Paracetamol as an adjunct to Nalbuphine in the management of post-operative pain following elective cardiac surgery.
STUDY DESIGN: Randomized (single-blind) control trial.
SAMPLING TECHNIQUE: Computer generated, randomized selection of patients with 50% probability of assignment into either group.
PLACE AND STUDY DURATION: (single center) PICU and Neurosurgery HCU at the Cipto Mangunkusumo National Referral Center Hospital, Jakarat, Indonesia, over a period of 6 months, from March to August 2022.
METHODS: Eighty-five patients (46 in paracetamol group and 39 in ketorolac group) were randomly assigned to receive either Paracetamol (treatment) or Ketorolac (control), along with the usual pre and intraoperative sedative/analgetics, and opioid as indicated over the first 48 hours postoperatively. The treatment group received injection Paracetamol 15mg/kg six hourly, whereas control group received injection Ketorolac 0.5mg/kg eight hourly.
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
- Double (Participant, Investigator)
盲法说明
Patient does not know what analgetics are given, investigator also do not evaluate pain therefore is masked from the intervention given
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postoperative patients admitted to Neurosurgery HCU or PICU
- •Parents/guardian signed informed consent forms
排除标准
- •History of allergy to paracetamol and ketorolac
- •Administration of opioid 24 hours before surgery
- •Liver dysfunction
- •Renal failure
研究组 & 干预措施
Paracetamol
Paracetamol 15mg/kg 6 hourly for 48 hours post-operatively
干预措施: Paracetamol (Drug)
Ketorolac
Ketorolac 0.5mg/kg 8 hourly for 48 hours post-operatively
干预措施: Ketorolac (Drug)
结局指标
主要结局
Pain change
时间窗: Total 48 hours (0, 8, 12, 24 and 48 hours) post operation
Post operative analgesic assessment using rFLACC: a pain scoring used primarily for unconscious or disabled children. 0 no pain at all, 10: worst pain (range 0 - 10) Grading is based on the clinical and subjective signs defined in the scoring. For the purposes of this study "adequate pain relief" was defined as achieving a pain score of four or less.
次要结局
- Change in Opioid usage(48 hours post operatively)
- Adverse effects(48 hours post operatively)
研究者
Radhian Amandito
Pediatrics Resident, Principal Investigator
Indonesia University