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临床试验/NCT05500599
NCT05500599进行中(未招募)不适用

Effects on Recovery of Children Undergoing Elective Surgery: Comparison of Intravenous Formulation of Fentanyl Citrate and Midazolam Administered Orally for Premedication

Alexandria University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3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
进行中(未招募)
入组人数
60
试验地点
1
主要终点
effect of both premedicants on recovery

研究概览

简要总结

To study and compare the efficacy of intravenous formula of fentanyl citrate and midazolam administered orally for premedication in paediatric surgical patients. Primary objectives will be the effect of both premedicants on recovery. The secondary outcomes will be time of onset and level of sedation, acceptance of premedication, and adverse effects. Sixty paediatric patients of either sex, in the age group of 2-8 years, with the American Society of Anaesthesiologists (ASA) Physical status I, posted for elective Genito-urological surgeries under general anaesthesia (GA) will be studied after clearance from the Institutional Ethics Committee and after obtaining written informed consent from a parent or a legal guardian

详细描述

Effects on Recovery of Children Undergoing Elective Surgery: Comparison of Intravenous Formulation of Fentanyl Citrate and Midazolam Administered Orally for Premedication

Introduction Paediatric preoperative anxiety has been a concerning matter for the past decades with a high prevalence and several adverse outcomes branching into social, developmental, behavioural, and perioperative fields. The anticipation of pain, separation from family, and fear of surgery are few of the factors that trigger perioperative anxiety in children. However, the routine use of anxiolytic premedication before anaesthetic induction is debated. Furthermore, premedication may significantly affect recovery from anaesthesia.

Premedication causes sedation and reduction of anxiety during separation from parents. It also provides a calm and cooperative child for smooth induction of anaesthesia. The oral route of administration of the drugs is the most acceptable and a nontraumatic route, especially in children. The total volume of the oral premedication can be kept at 0.2 ml/kg which is far below the gastric fluid volume of 0.4 ml/kg above which the risk of aspiration increases. Lipid-soluble drugs that can be supplied as water-soluble salts provide the opportunity to use it through oral route of administration for premedication.

The salt fentanyl citrate is soluble in water. These properties suggest that fentanyl citrate can be incorporated for use as a premedicant. This lipid-soluble opioid when placed in normal conditions of the mouth is 80% nonionized, making it the only opioid suitable for transmucosal absorption. However, bioavailability depends on the fraction of the dose that is absorbed through the oral mucosa (~25%) and the fraction that is swallowed (~75%, swallowed dose is only partially bioavailable).

Midazolam, a benzodiazepine, has been routinely used orally for premedication in children scheduled for surgery. Bioavailability of oral midazolam varies from 15% to 27% in children. It has a rapid onset and short duration of action. It is reliable in achieving sedation and anxiolysis. However, search for a better alternative continues due to concerns such as bitter taste, cognitive impairment, long-term behavioural disturbances, paradoxical reactions, hiccups, and respiratory depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double blinded

入排标准

年龄范围
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • (ASA) Physical status I,
  • posted for elective Genito-urological surgeries under general anaesthesia (GA)

排除标准

  • known allergy to fentanyl or midazolam,
  • intellectual and developmental disabilities,
  • psychosomatic disorders,
  • history of any sedative or analgesic intake,
  • ASA physical status ≥ 2,
  • upper respiratory tract infection,
  • history of previous surgery,
  • being accompanied by a non-family member

研究组 & 干预措施

fentanyl (Group F)

Active Comparator

receive 10 μg/kg fentanyl orally approximately 30 min before the induction of anaesthesia

干预措施: Fentanyl Citrate (Drug)

结局指标

主要结局

effect of both premedicants on recovery

时间窗: immediately after the surgery average 2 hours postoperative

1. The quality of recovery will be evaluated using the three objective components in the modified pain/discomfort scale. Each variable scoring 0-2 points (best to worst). If the total score on the pain/discomfort scale at any evaluation point exceeded 3, the child will be regarded as suffering from postanaesthetic excitement. score 0 1 2 Crying Not crying Responding to pain Not responding to comforting Moving None Restless Thrashing Agitation Asleep/calm Mild agitation Sever agitation/Hysterical

次要结局

  • Time to recovery(immediately after the surgery average 2 hours postoperative)
  • time of onset and level of sedation,(Before the surgery starts)
  • acceptance of premedication(after ingestion of the premedication and before the surgery starts)

研究者

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

Ahmed Shehab, MD

lecturer Of Anaesthesia and Surgical intensive care

Alexandria University

研究点 (1)

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