Clinical trial NCT00880607: Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
Official title: The Use of Intraoperative Intrathecal Morphine Versus Epidural Extended Release Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Management
Spinal Fusion
Scoliosis
Keywords: Pain
Pediatric
Spinal Fusion
pain management
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2009-04-14
Enrollment: 84
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 for surgery the anesthesiologist will give them either (1) a single injection of morphine into the spinal fluid in the lower back, or (2) a single injection of extended-release morphine into the epidural space (just outside the spinal fluid) in the lower back.

The usual care for patients having this surgery is a single injection of morphine into the spinal fluid in the lower back. If randomized to group (1), subjects will receive the usual care for pain control. If subjects are randomized to group (2), they will receive a single injection of extended-release morphine into the epidural space.

During surgery, a small blood sample (1 teaspoon or less) will be collected to analyze specific DNA sequences that are involved in individual responses to morphine for pain control. The blood sample will be destroyed after 24 months.

After surgery, subjects will have IV pain medication through a patient-controlled analgesia (PCA) machine. Subjects will be shown how to work the PCA so they can get the pain medicine when they need it. A research nurse will check in frequently to ask how much pain is occurring following the surgery and any side effects that may arise from the study medicine.

Subjects will be in this study up to 60 hours after surgery.

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.

Primary outcomes:
measure: Total IV Morphine Consumption up to 48 Hours Post Surgery
timeFrame: Four hour intervals for up to 48 hours
Secondary outcomes:
measure: Time Until First PCA Demand Request
timeFrame: every 4 hours up to 48 hours
measure: Post-operative Pain Scores
timeFrame: every 4 hours up to 48 hours
measure: Adverse Opioid Effect: Nausea
timeFrame: every 4 hours up to 48 hours
measure: Adverse Opioid Effect: Emesis
timeFrame: every 4 hours up to 48 hours
measure: Adverse Opioid Effect: Pruritus
timeFrame: every 4 hours up to 48 hours
measure: Adverse Opioid Effect: Respiratory Depression
timeFrame: every 4 hours up to 48 hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: The Children's Hospital- Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Mindy Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: