Study of Morphine in Postoperative Infants to Allow Normal Ventilation

• Status: Completed
• Trial end date: 1998-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Children's Hospital
• Treatments: Morphine

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