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临床试验/NCT05194904
NCT05194904Unknown2 期

Intrtavenous Ketorolac Versus Intravenous Dexmedetomidine for Postoperative Analgesia After Hypospadius Repair

Assiut University0 个研究点目标入组 60 人开始时间: 2022年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
60
主要终点
Total analgesic consumption in the first 24 hours after surgery

研究概览

简要总结

This study aimed to evaluate the efficacy of intravenous ketorolac versus dexmedetomidine as analgesia after Hypospadias repair surgery to determine the optimal procedure for pain control and postoperative reduction of analgesic use

详细描述

The guidelines of the American Society of Anesthesiologists (ASA) for the treatment of pain in the perioperative period define postoperative acute pain as pain present in surgical patients following the procedure.1 Almost 80% of patients undergoing surgery experience postoperative pain, and 80% of them reported moderate to severe pain intensity.2 Inadequate management of postoperative pain may lead to development of complications and prolonged recovery time with increased morbidity and mortality rates in adults.3,4 Although equivalent data for children are not available, this evidence warrants caution in pediatric population too. Appropriate treatment of postoperative pain contributes to shorter time of hospitalization, lower hospital costs, and increased level of patient satisfaction. There is enough evidence that an ineffective treatment of postoperative pain is in positive correlation with delayed wound healing, and the negative development of pain perception and chronic pain in the future.5,6 Hypospadias repair surgery is an invasive procedure whose postoperative phase is very painful.7 Pain management can be counted as an important step in all surgeries, especially in pediatric and neonatal surgical procedures. It has been reported that up to 40% of the children undergoing surgeries suffer from moderate to severe post-operative pain.8 In addition to the significance of post-operative pain management in the quality of life and satisfaction of the patients, it plays a great role in minimizing the complications and improving the surgery outcome in certain types of surgeries. In hypospadias surgery, post-operative pain results in manipulation of wounds and consequent infection, hemorrhage, and wound dehiscence.9 These complications cause significant preventable morbidities. Post-operative pain management also alleviates the local and systemic inflammation resulting in more favorable outcomes.10

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that has an analgesic efficacy similar to commonly used opioids, and that recently has found wide acceptance in the treatment of postoperative pain in a variety of surgical procedures. Ketorolac is used for moderate pain relief; it may be used to treat severe pain when associated with opioids, reducing the opioid dose. The advantage of this association is the reduction of opioid side effects such as respiratory depression, pruritus, urinary retention, sedation and nausea . 11,12,13 Dexmedetomidine is a highly selective α2-adrenergic receptor agonist commonly used in neurosurgery . The advantages of dexmedetomidine include reducing perioperative catecholamine to maintain intraoperative hemodynamic stability and exerting the unique neuroprotective effects by inhibiting the release of glutamate, pro-apoptotic proteins, and pro-inflammatory cytokines. In addition, previous studies have shown that it can reduce sedative and opioid consumption and provide better analgesic effects with lesser concern for side effects than opioids

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I & II.
  • Age between 2 years & 6 years old.
  • Body weight below 30 Kg.

排除标准

  • Any contraindications to any drug used
  • patients refusal
  • recurrent surgery

研究组 & 干预措施

group 1

Active Comparator

ketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg

干预措施: Dexmedetomidine (Drug)

group 2

Active Comparator

Dexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Total analgesic consumption in the first 24 hours after surgery

时间窗: first 24 hours

Total analgesic consumption in the first 24 hours after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Samir Ghitany

resident

Assiut University

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