Study of Morphine in Postoperative Infants to Allow Normal Ventilation
morphine
Congenital, Hereditary, and Neonatal Diseases and Abnormalities+7
+ Neurologic Manifestations
+ Pathologic Processes
Summary
Study start date: August 1, 1994
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 1 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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