Status:
COMPLETED
Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
Lead Sponsor:
University of Colorado, Denver
Conditions:
Pain Management
Spinal Fusion
Eligibility:
All Genders
8-17 years
Phase:
PHASE4
Brief 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...
Detailed Description
Up to 80 people from Denver will participate in the study. Subjects will be randomized to receive one of two possible medications during surgery to help with pain after surgery. After they go to sleep...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00880607
Start Date
December 1 2008
End Date
September 1 2012
Last Update
April 22 2020
Active Locations (1)
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1
The Children's Hospital- Denver
Aurora, Colorado, United States, 80045