Study of Morphine in Postoperative Infants to Allow Normal Ventilation

NCT00004696 | Completed

• 4 other identifiers: 199/13359CHMC-S-FDR001015CHMC-S-IRB-022-9801CHMC-S-IRB-148-9706
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Infant, Newborn, Diseases; Pain

Keywords

disease-related problem/condition; pain; intraoperative/postoperative complications; rare disease

Interventions

morphine DRUG

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Related Publications (1)

• Lynn A, Nespeca MK, Bratton SL, Strauss SG, Shen DD. Clearance of morphine in postoperative infants during intravenous infusion: the influence of age and surgery. Anesth Analg. 1998 May;86(5):958-63. doi: 10.1097/00000539-199805000-00008.

  PMID: 9585276 BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases; Pain; Postoperative Complications; Rare Diseases

Interventions

Morphine

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Disease Attributes

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Anne M. Lynn

  Seattle Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: August 1, 1994
• Study Completion: July 1, 1998
• Last Updated: March 25, 2015

Record last verified: 1999-05