Study of Morphine in Postoperative Infants to Allow Normal Ventilation
morphine
Enfermedades y Anomalías Congénitas, Hereditarias y Neonatales+5
+ Manifestaciones Neurológicas
+ Procesos Patológicos
Resumen
Fecha de inicio: 1 de agosto de 1994
Fecha en la que se inscribió al primer participante.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
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 100 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Hasta 1 Años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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