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Study of Morphine in Postoperative Infants to Allow Normal Ventilation
This study is ongoing, but not recruiting participants.
Study NCT00004696   Information provided by FDA Office of Orphan Products Development
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes

February 24, 2000
June 23, 2005
August 1994
 
 
 
Complete list of historical versions of study NCT00004696 on ClinicalTrials.gov Archive Site
 
 
 
Study of Morphine in Postoperative Infants to Allow Normal Ventilation
 

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.

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.

 
Interventional
Educational/Counseling/Training, Randomized
  • Infant, Newborn, Diseases
  • Pain
Drug: morphine
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
 
 

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
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00004696
 
199/13359, CHMC-S-FDR001015, CHMC-S-IRB-022-9801, CHMC-S-IRB-148-9706
FDA Office of Orphan Products Development
Seattle Children's Hospital
Study Chair: Anne M. Lynn Seattle Children's Hospital
FDA Office of Orphan Products Development
May 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP