跳至主要内容
临床试验/NCT05817474
NCT05817474已完成不适用

Efficacy of Local Infiltration of Tranexamic Acid and Lidocaine in Tonsillar Bed on Postoperative Bleeding and Pain During Tonsillectomy Surgery.

mohamed1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
1
主要终点
Postoperative bleeding, pain and postoperative opioid consumption

研究概览

简要总结

All anesthetic techniques aim to lessen intra-operative surgical site bleeding because it is a major problem and does not help with precision, surgery time, or postoperative wound healing. The main reason for reoperation and mortality in children who have had tonsillectomies is post-tonsillectomy hemorrhage. Pre-emptive analgesia reduces surgical pain blocking of central sensitization by topical or systemic medications.

详细描述

The control of postoperative pain in children after tonsillectomy is a crucial issue. After a tonsillectomy, it is crucial to receive enough postoperative analgesia since discomfort limits swallowing, increases the risk of dehydration, infection, and subsequent bleeding, and can impede a quick recovery and painless convalescence. Immediately following surgery and during the first 24th hours, this pain is at its most intense (1).

The main reason for reoperation and mortality in children who have had tonsillectomy is post-tonsillectomy hemorrhage (PTH). These two categories of PTH as primary bleeding in the first 24 hours and secondary bleeding (after 24th hours). Most PTH cases are secondary, with incidence reaching its peak between days 5 and 7 after surgery when the fibrin clot breaks from the tonsillar fossa. PTH requiring surgical intervention will be an emergency that most anesthesiologists will encounter in their clinical practice (2).

In numerous surgical procedures, bleeding has been observed to be reduced by antifibrinolytic transexamic acid (3). It has been demonstrated that transexamic acid can reduce blood loss during tonsillectomy but has no impact on whether PTH develops in tonsillectomy patients. When administered by nebulization in the emergency room to a patient who was 3 years old, tranexamic acid has been found to reduce secondary PTH (4).

Plasminogen activation is competitively inhibited by tranexamic acid. As a result of inhibition of the fibrinolysis, it prevents the clots from being broken down thereby significantly reducing surgical hemorrhage. After surgical stress, fibrinolysis occurs more frequently, especially in complex surgeries like total knee arthroplasty. Fibrinolysis reaches its peak six hours after surgery and continues to occur at a high rate for up to 18 hours. When administered during this time, tranexamic acid can significantly less blood loss (5). In those who are predisposed, thrombosis risk from tranexamic acid exists. Orthostatic difficulties, vision abnormalities, headaches, myoclonus, and rash are among other uncommon adverse effects.

The safety and efficacy of tranexamic acid (TXA) have been well studied by surgical services including cardiac, orthopedic, dental, trauma, critical care, and dermatologic surgery. However, except for craniofacial surgery (6). The most serious problems following a tonsillectomy include hemorrhage and respiratory obstruction from edema. The most frequent complaint in the initial post-operative phase is pain. With individual differences, the pain increases anxiety and the fear of swallowing, predisposes to delayed food intake, reduces respiratory effort, increases the risk of pulmonary problems, and lengthens hospital stays (7).

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
Single (Participant)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group T

Experimental

Group T: received lidocaine (2 %) 2 ml and tranexamic acid 2 ml in each tonsillar bed;

干预措施: lidocaine (2 %) 2 ml and tranexamic acid (Drug)

Group N

Placebo Comparator

Group N (Control group): received 4 ml of normal saline in each tonsillar bed.

干预措施: lidocaine (2 %) 2 ml and tranexamic acid (Drug)

结局指标

主要结局

Postoperative bleeding, pain and postoperative opioid consumption

时间窗: 12 month

Postoperative bleeding, pain and postoperative opioid consumption

次要结局

未报告次要终点

研究者

发起方
mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

mohamed

assissant professor of anesthesia

Azhar University

研究点 (1)

Loading locations...

相似试验