Clinical trial NCT00880607
Conditions: Pain Management Spinal Fusion Scoliosis
Keywords: Pain Pediatric Spinal Fusion pain management
Sponsor: University of Colorado, Denver
Start date: 2008-12-01; Completion date: 2012-09-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Receives a single dose of intrathecal morphine arm 2: Receives DepoDur extended release epidural morphine for pain management
Interventions: intervention 1: Intrathecal morphine intervention 2: Extended Release Epidural Morphine
Intervention descriptions: intervention 1: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain. intervention 2: 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.

Protocol documents: