The Effect of Opiate Administration in Children With Acute Abdominal Pain and Peritoneal Signs on the Decision for Surgical Intervention
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To demonstrate that IV morphine will alleviate pain in children presenting to the Emergency Department with abdominal pain and peritoneal signs, without changing the patient's physical exam and the subsequent surgeon's operative decision.
研究概览
简要总结
Surgeons are the individuals who will operate on a patient if it is determined to be necessary after they present with abdominal pain. For that reason, the investigators want to study if giving a medicine (morphine) to children presenting to the ED with abdominal pain will alleviate pain without changing the patient's physical exam and the subsequent surgeon's decision.
The investigators also will record any side effects of morphine, any associated surgical complications, and to identify the ultimate diagnosis.
详细描述
Unfortunately, the current standard of care obviates the use of pain medication in children with acute abdominal pain while waiting for the attending pediatric surgeon to perform their examination and determine if the patient requires operative intervention. This process can sometimes be protracted.
This practice occurs currently because of the concerns that analgesia may alter physical findings, interfere with the diagnosis, and delay definitive surgical intervention resulting in increased morbidity. This point of view has been challenged recently.
We designed this study taking into account the paramount importance of the pediatric surgeon's role in determining the need for operative intervention in the ultimate management of patient's presenting with acute abdominal pain and signs and symptoms of peritonitis.
Our primary objective is to demonstrate that the administration of intravenous morphine will alleviate pain in children presenting to the Emergency Department (ED) with abdominal pain and peritoneal signs, without changing the patient's physical exam and the subsequent surgeon's operative decision.
Secondary objectives include recording any adverse events of morphine and associated surgical complications, and identification of the ultimate diagnosis.
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
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •Children aged 1 to18 years of age who present with acute abdominal pain and signs of peritoneal irritation of less than 5 days duration.
- •Pain scores from moderate to severe
- •Need for intravenous access and require surgical consultation.
排除标准
- •Pregnancy
- •Chronic pain (defined as pain of more than two weeks' duration).
- •Constipation (Bowel movement less than 3imes/week, hard, small, or difficult to eliminate)
- •Prior abdominal surgery or traumatic abdominal pain.
- •History of gastritis, peptic ulcer disease, gastro esophageal reflux disease.
- •Chronic illnesses associated with pain such as Ulcerative colitis, Crohn's disease, sickle cell disease or altered perception to pain (autism, spina bifida, altered mental status).
- •Previous use of morphine sulfate or other narcotic/medication known to alter pain
- •Perception or mental status six hours prior to presentation in the ED.
- •Prior allergy or anaphylaxis to morphine.
- •Acute respiratory distress, hypotension (less than 5thpercentile for age).
- •Renal, pancreatic or biliary disease
研究组 & 干预措施
Morphine
Morphine Sulfate: If weight is <50 Kg; Morphine 0.1mg/kg IV to a maximum of 10mg can be given; if weight ≥ 50 Kg a maximum of 10mg can be given.
干预措施: Morphine Sulfate (Drug)
Placebo
Normal saline
干预措施: Morphine Sulfate (Drug)
结局指标
主要结局
To demonstrate that IV morphine will alleviate pain in children presenting to the Emergency Department with abdominal pain and peritoneal signs, without changing the patient's physical exam and the subsequent surgeon's operative decision.
时间窗: 2 Hours post-medication
次要结局
- Secondary objectives include recording any adverse events of morphine and associated surgical complications, and identification of the ultimate diagnosis.(2 weeks)