Study of Morphine in Postoperative Infants to Allow Normal Ventilation

This study is ongoing, but not recruiting participants.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Seattle Children's Hospital
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004696

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized

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:

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.

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
ClinicalTrials.gov Identifier:	NCT00004696 History of Changes
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

Study placed in the following topic categories:

Morphine
Postoperative Complications
Rare Diseases
Central Nervous System Depressants
Infant, Newborn, Diseases

Narcotics
Pain
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Morphine
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Infant, Newborn, Diseases

Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009