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Study of Morphine in Postoperative Infants to Allow Normal Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 1999 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Seattle Children's Hospital
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004696
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: May 1999
History of Changes
  Purpose

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
Primary Purpose: Educational/Counseling/Training

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 100
Study Start Date: August 1994
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.

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004696

Sponsors and Collaborators
FDA Office of Orphan Products Development
Seattle Children's Hospital
Investigators
Study Chair: Anne M. Lynn Seattle Children's Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00004696     History of Changes
Other Study ID Numbers: 199/13359, CHMC-S-FDR001015, CHMC-S-IRB-022-9801, CHMC-S-IRB-148-9706
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Infant, Newborn, Diseases
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013