Study of Morphine in Postoperative Infants to Allow Normal Ventilation
OBJECTIVES: I. Compare nonmechanically ventilated infants who receive morphine postoperatively as intermittent intravenous bolus doses or as a continuous intravenous infusion targeted to reach a steady-state concentration.
II. Assess ventilation (blood gases, continuous oximetry, and CO2 response curves) and analgesia (infant pain score) between the two treatment groups of infants.
III. Compare ventilation parameters (blood gases, CO2 response curves, and time to wean from assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.
研究概览
详细说明
PROTOCOL OUTLINE: This is a two part study. Infants are stratified by age (1-30 days vs 31-180 days vs 181-365 days) and by type of surgery. Infants are randomly assigned to one of two treatment arms.
In part I, following major thoracic, abdominal, or cardiac surgery, infants are randomized to receive either continuous IV morphine infusions (arm I) or to receive morphine by single IV bolus doses every 2-3 hours (arm II).
In part II, cyanotic and acyanotic infants following thoracotomy receive morphine by 2 loading doses over 15 minutes and then by continuous IV infusion.
Patients are followed for at least 2 days.
Completion date provided represents the completion date of the grant per OOPD records
研究类型
注册
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Infants scheduled for surgery with postoperative inpatient care
- Must be born after 35 weeks or more gestational age
- No prenatal opiate exposure
Part I patients:
- Less than 12 months of age undergoing surgeries involving major thoracic, abdominal, or cardiac procedures
- No pneumonectomy, tracheal or bronchial stenosis reconstruction, diaphragmatic hernia repair, or surgeries resulting in high intraabdominal pressure (closure of large gastroschisis or omphalocele defects)
- No hepatic or renal transplantation
Part II patients:
- Less than 3 months of age undergoing surgeries using a thoracotomy approach
- Cyanotic congenital heart disease having palliative systemic to pulmonary artery shunts created OR Thoracotomy for repair of acyanotic lesions (e.g., repairs of coarctation of the aorta, tracheoesophageal fistula repair, PDA ligation)
--Patient Characteristics--
- Age: Part I: Less than 12 months Part II: Less than 3 months
- Hepatic: Normal hepatic function tests
- Renal: Normal renal function tests
- Pulmonary: No pulmonary disease causing baseline hypercarbia
- No pulmonary hypertension contraindicating use of 5% CO2 in rebreathing studies
Other:
- No allergy to morphine
- No severe developmental delay that precludes analgesia scoring
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
合作者和调查者
调查人员
- 学习椅:Anne M. Lynn、Seattle Children's Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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