Study of Morphine in Postoperative Infants to Allow Normal Ventilation

NCT ID: NCT00004696

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-08-31
• Study Completion Date: 1998-07-31

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.

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

Conditions

Infant, Newborn, Diseases; Pain

Study Design

• Allocation Method: RANDOMIZED

Interventions

morphine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Anne M. Lynn

Role: STUDY_CHAIR

Seattle Children's Hospital

References

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. doi: 10.1097/00000539-199805000-00008.

Reference Type: BACKGROUND

PMID: 9585276 (View on PubMed)

Other Identifiers

CHMC-S-FDR001015

Identifier Type: -

Identifier Source: secondary_id

CHMC-S-IRB-022-9801

Identifier Type: -

Identifier Source: secondary_id

CHMC-S-IRB-148-9706

Identifier Type: -

Identifier Source: secondary_id

199/13359

Identifier Type: -

Identifier Source: org_study_id