Study of Morphine in Postoperative Infants to Allow Normal Ventilation
morphine
Maladies et anomalies congénitales, héréditaires et néonatales+7
+ Manifestations Neurologiques
+ Processus pathologiques
Résumé
Date de début de l'étude : 1 août 1994
Date à laquelle le premier participant a commencé l'étude.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
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.100 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 1 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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