Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
Condition: Pain Management; Spinal Fusion; Scoliosis
MeSH terms: Scoliosis
Intervention: Intrathecal morphine; Extended Release Epidural Morphine
Intervention description: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.; DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.
Intervention MeSH terms: Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pain; Pediatric; Spinal Fusion; pain management

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.
    

Eligibility 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.