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临床试验/NCT00380497
NCT00380497已完成4 期

Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in children-a Single Blinded Randomized Controlled Trial

The Hospital for Sick Children1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
83
试验地点
1
主要终点
Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents

研究概览

简要总结

The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before colonoscopy in children, and to compare effectiveness.

详细描述

Good bowel cleanout before colonoscopy is commonly associated with significant discomfort that children do not tolerate well. Many pediatric centers in North America use Poly-Ethylene Glycol and electrolyte solution (PEG-ELS, Golytely®) for bowel lavage administered in a large volume, often causing nausea, vomiting and bloating. This is often poorly tolerated by children who usually require the insertion of a nasogastric tube and a day admission. Recently, Pico-Salax was approved in Canada for bowel cleanout in children. It is administered in two divided doses, each in one cup of water; it is palatable and does not have to be given in hospital. However, no controlled study in children compared it with the current standard of care. Our preliminary experience and previous literature suggest that it is effective and well tolerated. We propose to study whether colon cleanout for colonoscopy with Pico-Salax is better tolerated than Golytely in children, by a single blinded randomized controlled trial. Positive results of this study will facilitate a better tolerated regimen for bowel clean out in children.

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
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children between 4 and 18 years of age
  • Undergoing full elective ambulatory colonoscopy

排除标准

  • Evidence of bowel obstruction, prior partial or total colectomy and significant renal failure (GFR<50 mls/min/1.73 m2)
  • Second dose of Pico-Salax will not be given to children with blood pressure less than the tenth percentile or pulse rate >90th% of normal reference value for age, or in children with a clinical need for bolus IV fluids decided by the clinical fellow

研究组 & 干预措施

Pico-Salax

Experimental

干预措施: Pico-Salax® (Drug)

PEGlyte

Active Comparator

干预措施: PEG-Lyte® (Drug)

结局指标

主要结局

Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents

次要结局

  • Cleanout effectiveness (measured by: rating of a blinded gastroenterologist, the need for enema supplement, procedure length and whether the planned destination was reached
  • Side effects (measured by: dehydration assessment, questionnaires completed by the nurse and the patient, and blood tests)

研究者

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

Simon Ling

Staff Gastroenterologist

The Hospital for Sick Children

研究点 (1)

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