Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this study plans to learn about individual differences in the how the different kinds of morphine work in children.

Subjects are being asked to be in this research study because they are having spinal fusion surgery, will have pain some of the time and will be getting morphine during and after surgery to help control their pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Morphine

Criteria

Inclusion Criteria:

1. Male and females, 8 to17 years old undergoing posterior spinal fusion for idiopathic scoliosis.

2. Fusion of a minimum of 5, and a maximum of 13 levels, including at least L1 or lower.

Exclusion Criteria:

1. Neuromuscular scoliosis.

2. A history of documented coagulopathy or platelet count of less than 100,000 mm3.

3. A known allergy or adverse sensitivity to morphine.

4. Pulmonary hypertension or other significant respiratory problem.

5. Cognitive deficits that would impair use of PCA and/or filling out questionnaire.

6. History of sleep apnea defined by sleep study and/or need for nighttime CPAP.

7. Abnormal pain thresholds (i.e., subjects who are on significant opioids preoperatively).

8. Baseline neurologic deficits (numbness, motor deficits, or any focal neurological sign).

9. Subjects who are anticipated to remain intubated postoperatively for longer than 2 hours.

10. Need for preoperative intravenous inotropic drugs.

11. Significant metabolic, endocrine or neuropathology, cyanosis, or renal insufficiency.

12. A contraindication to dural puncture, such as raised intracranial pressure.

13. Pre-operative heparin, oral aspirin or anticoagulants.

14. Weight less than 20kg or greater than 100kg.

15. Need for Intraoperative ketamine administration.