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临床试验/NCT01912807
NCT01912807已完成不适用

Intravenous Dextrose Versus Ondansetron for Prevention of Postoperative Vomiting in Children: a Randomized Non-inferiority Trial

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年12月最近更新:
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
入组人数
300
试验地点
1
主要终点
Number of Participants With Postoperative Vomiting Between 0 to 2 Hours

研究概览

简要总结

The aim of this study was to investigate the efficacy of intraoperative intravenous dextrose in preventing POV in pediatric population undergoing dental day surgery.

Post-operative vomiting (POV) in children is a frequent complication. Studies using intravenous (IV) fluids containing dextrose in the perioperative period have shown improvement of POV in adults. Similar studies have not been done in children.

Knowing that Intravenous (IV) fluids containing dextrose are safe and commonly used in the paediatric population, this intervention could potentially reduce the amount of rescue antiemetic medications and improve recovery in same-day surgery paediatric patients.

详细描述

A non-inferiority randomized control trial of healthy children (3-9 years old) undergoing ambulatory dental surgery was conducted to investigate the efficacy of intraoperative IV fluids containing dextrose for antiemetic prophylaxis.

The control group (146 participants) received dexamethasone (0.15 mg/kg IV) and ondansetron (0.05 mg/kg IV); the intervention group (144) received dexamethasone (0.15 mg/kg IV) and intravenous 5% dextrose in 0.9% normal saline (D5NS) as per a weight based maintenance rate.

Patients underwent a general anesthetic maintained with a volatile anesthetic. There was not a standardized protocol for anesthetic induction and maintenance, and all types and doses of anesthetic medications were chosen and administered at the discretion of the anesthesiologist. Intraoperative administration of any other antiemetic medications constituted protocol violation and excluded the patient from analysis. There were no modifications to the planned dental procedure.

Once IV access was established and the patient was intubated, the maintenance study solution was connected and infused throughout the operative period. Additional fluid (Ringer's Lactate) was available to the anesthesiologists to administer as per their preference.

The study drug was administered to the patient by the anesthesiologist at the end of the procedure, when the throat packing was removed and the IV maintenance study solution was stopped. Before emergence from anesthesia, the researcher measured and recorded the patient's blood sugar via a chemstrip (AccuCheck aviva ®). Ringer's Lactate IV fluid, not part of study protocol, was continued in recovery based on the anesthesiologist's preference.

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
3 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 3 to 9 Years of age
  • Male and Female
  • ASA I and II
  • Paediatric patients undergoing same-day dental procedures at the Prairieview Surgical Centre.

排除标准

  • Age <3 or >9
  • Underlying pro-emetic disease
  • Positive history of POV in the patient, parent or sibling
  • Currently on antiemetic medications
  • Parent refusal to sign consent
  • History of juvenile diabetes

研究组 & 干预措施

Dextrose (D5NS)

Experimental

The participants received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis and Dextrose 5% in 0.9 % Normal Saline (D5NS) was used as a second antiemetic, at an intravenous rate calculated based on their weight and determined for the purpose of the study.

干预措施: Dextrose (D5NS) (Drug)

Ondansetron (Control)

Active Comparator

The control group received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis. Ondansetron (dose 0,05 mg/Kg) was used as a second prophylactic antiemetic.

干预措施: Ondansetron (Control) (Drug)

结局指标

主要结局

Number of Participants With Postoperative Vomiting Between 0 to 2 Hours

时间窗: 0 to 2 hr after the procedure (in PACU)

In the Post Anesthetic Care Unit (PACU) the proper data (intraoperative and recovery period) was recorded at immediate postoperative period, at 2 hours after the procedure and prior to discharge. Parents were informed during the consent process that postoperative 24 hour follow up was going to be done over the phone by researcher.

次要结局

  • Number of Participants Receiving Rescue Antiemetic Medications(2 to 24 hr after procedure)

研究者

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

Andrea Vasquez

Clinical Assistant Professor - University of Saskatchewan, Department of Academic Family Medicine

University of Saskatchewan

研究点 (1)

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