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临床试验/NCT07461376
NCT07461376招募中不适用

Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.

Cairo University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年4月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
84
试验地点
1
主要终点
Sedation level

研究概览

简要总结

Aim of the work Is to compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.

详细描述

Surgery and anesthesia induce considerable emotional stress on parents and children. Children are particularly vulnerable to this surgical stress response since their limited energy reserves; larger brain mass, compared to body size; and glucose requirements. Thus, controlling and preventing perioperative stress responses is crucial in modern pediatric anesthesia. Many postoperative negative behavioral changes such as nightmares and separation anxiety. In addition to these behavioral manifestations, preoperative anxiety activates the human stress response. So, a multimodal approach consisting of sedative drugs, parental presence, play therapy, familiar environment and effective pain therapy is necessary to reduce preoperative anxiety. The benzodiazepine midazolam has traditionally been used to relieve preoperative stress and provide sedation in pediatric patients; however, in higher doses, it has an increased risk of respiratory depression.

Alternatively, premedication with clonidine, although less popular, has been shown to reliably produce preoperative sedation and anxiolysis in children; furthermore, it has analgesic properties, decreases volatile anesthetic and opioids requirements and improves perioperative hemodynamic stability.

Clonidine, a selective centrally acting partial a2-agonist, traditionally, it has been used as an antihypertensive agent since the late sixties. Its primary effect is a sympatholytic drug, and it reduces peripheral norepinephrine release by stimulation of the prejunctional inhibitory alpha-2 adrenoceptors. Further uses based on its sedative, anxiolytic and analgesic properties are being developed.

Ketamine is a sedative premedication that is commonly used in children. It is an N-methyl D-aspartate (NMDA) receptor antagonist that produces sedation, immobilization, and analgesia without causing respiratory depression. It has been used in a variety of ways, most recently intranasal in children To the best of our knowledge, no previous studies compared between oral ketamine and oral clonidine as premedication in children undergoing elective lower abdominal day-case surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

盲法说明

● Patients will be randomized using a computer-generated randomization list. Random group assigned will be enclosed in a sealed envelope to ensure concealment of allocation sequence. The sealed envelope will be opened by an anesthesiologist who will not be involved in the study to prepare the drug solution according to randomization. The anesthesiologist administrating the drug and observing the patient will be blinded to the treatment group.

入排标准

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

入选标准

  • Children aged between 3 to 12 years old of both sexes undergoing elective lower abdominal day-case surgery such as: oblique inguinal herniorrhaphy, hypospadias correction and circumcision.
  • ASA I and II

排除标准

  • Parents refusal.
  • ASA risk score >II
  • Heart, lung, neurological, or central nervous system disorders (hypotension, hypovolemia, severe bradyarrhythmia, atrioventricular block II or III, acute cerebrovascular events, impaired consciousness, respiratory disorders with hypoventilation, myasthenia gravis and central sleep apnea syndrome)
  • Allergy from the used drugs.

研究组 & 干预措施

Group Oral Clonidine (OC)

Active Comparator

This group of children will be premedicated with oral clonidine (4 mic/Kg) 60 minutes preoperatively in a sip of water.

干预措施: Oral Clonidine (OC) (Drug)

Group Oral Ketamine (OK)

Active Comparator

This group of children will be premedicated with oral Ketamine (10 mg/Kg) 60 minutes preoperatively in a sip of water.

干预措施: Oral Clonidine (OC) (Drug)

结局指标

主要结局

Sedation level

时间窗: 60 minutes after administration of the drug (at time of separation from the parents).

using Ramsey sedation scale (RSS)

次要结局

  • Fentanyl administration.(at 10, 20, 30, 40, 50 minutes until the end of the surgery)
  • Postoperative emergence delirium(Postoperative at 15, 30, 45 and 60 minutes)

研究者

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

Omnia Yahia El Sayed Kamel

Lecturer of anesthesiology and surgical ICU and pain management

Cairo University

研究点 (1)

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