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| Tracking Information | |||||
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| First Received Date ICMJE | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | August 1994 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004696 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Morphine in Postoperative Infants to Allow Normal Ventilation | ||||
| Official Title ICMJE | |||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Educational/Counseling/Training, Randomized | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: morphine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | PROTOCOL ENTRY CRITERIA: --Disease Characteristics--
Part I patients:
Part II patients:
--Patient Characteristics--
Other:
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| Gender | Both | ||||
| Ages | up to 1 Year | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004696 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 199/13359, CHMC-S-FDR001015, CHMC-S-IRB-022-9801, CHMC-S-IRB-148-9706 | ||||
| Study Sponsor ICMJE | FDA Office of Orphan Products Development | ||||
| Collaborators ICMJE | Seattle Children's Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | FDA Office of Orphan Products Development | ||||
| Verification Date | May 1999 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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