The Use of Intraoperative Intrathecal Morphine Versus Epidural Extended Release Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion
Information source: The Children's Hospital, Denver
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Management; Spinal Fusion; Scoliosis
Intervention: DepoDur™ (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: The Children's Hospital, Denver Official(s) and/or principal investigator(s):
Mindy Cohen, MD, Principal Investigator, Affiliation: University of Colorado Denver
Overall contact:
Mindy Cohen, MD, Phone: 303-331-6871, Email: mindy.cohen@ucdenver.edu
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Objective data to analyze the primary outcomes of Time to first post-operative opioid-analgesic administration and Total opioid requirements during the first 48 hours after surgery
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
Minimum age: 8 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Mindy Cohen, MD, Phone: 303-331-6871, Email: mindy.cohen@ucdenver.edu
The Children's Hospital- Denver, Aurora, Colorado 80045, United States; Recruiting
Mindy Cohen, MD, Phone: 303-331-6871, Email: mindy.cohen@ucdenver.edu
Jeffrey Galinkin, MD, Phone: 720-777-6226, Email: jeffrey.galinkin@ucdenver.edu
Additional Information
Starting date: December 2008
Ending date: December 2010
Last updated: April 13, 2009
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