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

Completed · Phase 4

Conditions studied: Pain Management, Spinal Fusion, Scoliosis

In brief

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.

Key facts

Study ID

NCT00880607

Run by

University of Colorado, Denver

People needed

84

Starts

2008-12-01

Expected to finish

2012-09-01

Last updated by the study team

2020-04-22

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and females, 8 to17 years old undergoing posterior spinal fusion for idiopathic scoliosis.
• Fusion of a minimum of 5, and a maximum of 13 levels, including at least L1 or lower.

You may not qualify if…

• Neuromuscular scoliosis.
• A history of documented coagulopathy or platelet count of less than 100,000 mm3.
• A known allergy or adverse sensitivity to morphine.
• Pulmonary hypertension or other significant respiratory problem.
• Cognitive deficits that would impair use of PCA and/or filling out questionnaire.
• History of sleep apnea defined by sleep study and/or need for nighttime CPAP.
• Abnormal pain thresholds (i.e., subjects who are on significant opioids preoperatively).
• Baseline neurologic deficits (numbness, motor deficits, or any focal neurological sign).
• Subjects who are anticipated to remain intubated postoperatively for longer than 2 hours.
• Need for preoperative intravenous inotropic drugs.
• Significant metabolic, endocrine or neuropathology, cyanosis, or renal insufficiency.
• A contraindication to dural puncture, such as raised intracranial pressure.
• Pre-operative heparin, oral aspirin or anticoagulants.
• Weight less than 20kg or greater than 100kg.
• Need for Intraoperative ketamine administration.

Where it is running

• The Children's Hospital- Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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