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Study of Morphine in Postoperative Infants to Allow Normal Ventilation

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FDA Office of Orphan Products Development

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.

Condition Intervention
Infant, Newborn, Diseases Pain Drug: morphine

Study Type: Interventional
Study Design: Allocation: Randomized

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 100
Study Start Date: August 1994
Estimated Study Completion Date: July 1998
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.

Completion date provided represents the completion date of the grant per OOPD records


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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


  • No allergy to morphine
  • No severe developmental delay that precludes analgesia scoring
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004696

Sponsors and Collaborators
Seattle Children's Hospital
Study Chair: Anne M. Lynn Seattle Children's Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00004696     History of Changes
Other Study ID Numbers: 199/13359
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
Last Verified: May 1999

Keywords provided by FDA Office of Orphan Products Development:
disease-related problem/condition
intraoperative/postoperative complications
rare disease

Additional relevant MeSH terms:
Infant, Newborn, Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents