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临床试验/NCT05109416
NCT05109416已完成1 期

Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children

Minia University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年10月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
210
试验地点
1
主要终点
The first call for analgesia

研究概览

简要总结

Tonsillectomy is one of most common performed surgical procedure in children . tonsillectomy or adenotonsillectomy have high incidence of Post operative pain , it is very important and significant problem because it can lead to decrease oral intake and dehydration

详细描述

Tonsillectomy is one of the most common performed surgical procedure in children. Tonsillectomy or adenotonsillectomy have high incidence of Post operative pain incidence . There is still debate about the optimal analgesia for this common procedure , different methods have been described including intraoperative anesthetic pain regimens , adjustment of surgical technique , intraoperative local anesthetic injection and use of pharmacotherapy post operative .

The main goal of the preventive analgesia is the pain releif with minimum side effect . The objective of this study is to investigate and compare the effect of Glossopharyngeal nerve block for relief of pain on children following adenotonsillectomy .

This is prospective , double blinded , randomized study

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, Care Provider)

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • average weight is 10_50 kg
  • patient is generally stable
  • indication of tonsillectomy is recurrent tonsillitis
  • Ability to self report pain

排除标准

  • Hypersensitivity to bupivacaine
  • Obstructive sleep apnea syndrome
  • Pulmonary or cardic diseases

研究组 & 干预措施

Group B

Placebo Comparator

Children will receive sterile saline 0.9 , 5 cm in each side , by infiltration through anterior and posterior approaches

干预措施: Saline 0.9% (Drug)

Group A

Active Comparator

Children will receive bupivacaine 0.5% ( 1 mg / kg ) ,divided in each side , by infiltration through anterior and posterior approaches to block glossopharyngeal nerve

干预措施: Bupivacaine Hydrochloride 0.5% Injection Solution (Drug)

结局指标

主要结局

The first call for analgesia

时间窗: In 24 hours

Pain assessment using VAS scale

次要结局

  • The analgesic consumption(In 24 hours)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

basem saed abdalla

Resident

Minia University

研究点 (1)

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