Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Number of Participants With Main Symptom Improvement
研究概览
简要总结
The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.
详细描述
Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments.
Comparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation.
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
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Constipated children who have one of the following three conditions:
- •Fecal impaction (lower quadrant mass or dilated rectum with hard stool),
- •Functional fecal retention (large diameter stools as determined by caregiver <twice/week and retentive behaviors, or
- •Excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician
排除标准
- •Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)
- •Patients whose evaluation in the ED includes more than plain radiographs or urinalysis
- •Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)
- •Non-English speaking patients and families
- •Patients with milk allergy
- •Patients with molasses allergy
- •Patients who are pregnant
- •Patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery
- •Patients who are admitted to an in-patient unit
研究组 & 干预措施
enema
Rectal enema containing mixture of milk and molasses
干预措施: milk and molasses enema (Drug)
PEG 3350
Medication to be taken orally once each day for three consecutive days
干预措施: PEG 3350 (Drug)
结局指标
主要结局
The Number of Participants With Main Symptom Improvement
时间窗: 5 days
On day 5, the number of participants who respond "improved" to the question "Has your child's main symptom improved, stayed the same or gotten worse?"
次要结局
未报告次要终点
研究者
Melissa Miller
Assistant Professor
Children's Mercy Hospital Kansas City