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临床试验/NCT05124067
NCT05124067已完成1 期

Effect Of Dexmedetomidine, Dexamethasone And Ondansetron On Postoperative Nausea And Vomiting In Children Undergoing Dental Rehabilitation

Tanta University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2021年10月27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
入组人数
4
试验地点
1
主要终点
Number of participants who will develop postoperative nausea and vomiting and rate of development

研究概览

简要总结

this study will aim to evaluate the effects of dexmedetomidine, dexamethasone and Ondansetron on the prevention of postoperative nausea and vomiting in children undergoing dental rehabilitation surgery.

详细描述

Postoperative nausea and vomiting (PONV) is one of the most common and unpleasant postoperative complications, which is a major concern in surgical patients. PONV affects about 20-40% of surgical patients, with certain high-risk patients experiencing rates of up to 80%.

It has a high incidence in children, especially for tonsillectomy and dental surgery. PONV could lead to several adverse consequences, including dehydration, electrolyte imbalance, and wound dehiscence. it has also been reported PONV is associated with delayed hospital discharge, unplanned hospital admission, and increased financial costs required for patient care.

Several anti-emetic drugs have been described for the prophylactic control of PONV. Dexamethasone is common practice in surgery, as part of a multimodal pain and antiemetic strategy.

Ondansetron is a selective 5-HT3 receptor antagonist that exhibits an anti-emetic action by antagonizing vomiting signals in the afferent pathway from the stomach or small intestine and solitary tract nucleus and is effective at preventing PONV, however, the high cost of this drug has prevented it from being widely used.

Dexmedetomidine is a highly selective α2-adrenoreceptor agonist which has been widely used in clinical practice and has been explored extensively in the pediatric population due to its beneficial effects on perioperative morbidities. In the past few years, many studies in paediatrics have been published showing that dexmedetomidine lowered postoperative pain scores and opioid consumption, decreased the incidence of emergence agitation (EA), and improved the quality of recovery in pediatric patients undergoing different surgical procedures. In addition, a small selection of studies reported that dexmedetomidine could lower the incidence of nausea or vomiting after surgery and during the use of patient-controlled analgesia (PCA) in paediatrics. However, the effect of dexmedetomidine on PONV remains poorly understood.

研究设计

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

入排标准

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

入选标准

  • Pediatric patients 6-12 years.
  • Pediatric patients (ASA physical status I, II).
  • Scheduled for dental rehabilitation surgery

排除标准

  • Parental refusal
  • Allergy or contraindication to studied medication or anaesthetic agents.
  • Children with known gastroesophageal reflux disease.
  • Intake of antiemetic medication within 24 hours before surgery.
  • Past history or family history of previous postoperative nausea and vomiting.

研究组 & 干预措施

Group A (DEXA)

Experimental

patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)

干预措施: Dexamethasone (Drug)

Group B (ONDAN)

Experimental

patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)

干预措施: Ondansetron (Drug)

Group C (DEXMED)

Experimental

Patients will receive dexmedetomidine (0.3 μg/kg)

干预措施: Dexmedetomidine (Drug)

Group D (CONTROL)

Placebo Comparator

patients will receive normal saline

干预措施: normal Saline (Drug)

结局指标

主要结局

Number of participants who will develop postoperative nausea and vomiting and rate of development

时间窗: 24 hours

Postoperative vomiting will be recorded by a nurse who will be blinded to study conditions. It will be treated if vomiting occurred more than twice in 2 minutes with granisetron (0.1mg/kg and repeated if necessary but not in less than 12 hours).

次要结局

  • Postoperative pain(24 hours)
  • Emergence delirium(15 minutes)

研究者

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

AHMED ABDELAZIZ SHAMA

LECTURER OF ANESTHESIA AND SURGICAL ICU

Tanta University

研究点 (1)

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