Effect of Octreotide on the Colonic Motility in Pediatric Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Compared Colonic Motility Index From Fasting to Post Octreotide Infusion
研究概览
简要总结
The research study is designed to test how a medication called octreotide affects the motility (contraction or squeezing) of the colon (large intestine). Investigators are investigating whether octreotide can increase contraction and movement in the colon.
详细描述
As mentioned above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female and undergoing colonic manometry for a routinely accepted indication including: evaluation of chronic constipation, unexplained abdominal distension (Should have had previous diagnostic work up), recurrent fecal impaction, post Hirschsprung's disease repair, chronic intestinal pseudo-obstruction, or suspected colonic dysmotility of any other cause.
- •Children aged 12 months or older who are undergoing colonic motility under the supervision of Dr. Joseph Croffie at Riley Hospital.
- •In the investigator's judgment, parent(s)/guardian(s) is mentally competent to provide informed consent to participate in the study.
排除标准
- •• Subjects with known or suspected allergy to octreotide.
- •Subjects with known prolonged corrected QT interval (QTc) Syndrome or highest risk QTc-Prolonging Agents (including mifepristone).
- •Subjects with known history of ventricular arrhythmia.
- •Subjects with history of any organ transplant who are taking cyclosporine at the time of the motility study.
- •Subjects with history of small bowel transplant.
- •Subjects less than 12 months old.
- •Subjects with severe renal impairment
- •Subjects with severe hepatic impairment
- •Subjects taking bromocriptine, insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, quinidine, terfenadine, pimozide, sildenafil, tadalafil, and any agents to control fluid and electrolyte imbalance
研究组 & 干预措施
Octreotide
All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index.
干预措施: Octreotide (Drug)
Octreotide
All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index.
干预措施: Bisacodyl (Drug)
结局指标
主要结局
Compared Colonic Motility Index From Fasting to Post Octreotide Infusion
时间窗: Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.
Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH). Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes.
次要结局
未报告次要终点