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Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00880607
Recruitment Status : Completed
First Posted : April 14, 2009
Results First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Pain Management Spinal Fusion Scoliosis Drug: Intrathecal morphine Drug: Extended Release Epidural Morphine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Intrathecal morphine
Receives a single dose of intrathecal morphine
Drug: Intrathecal morphine
Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
Other Name: IT Morphine

Experimental: Extended Release Epidural Morphine
Receives DepoDur extended release epidural morphine for pain management
Drug: Extended Release Epidural Morphine
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.
Other Names:
  • EREM
  • DepoDur

Primary Outcome Measures :
  1. Total IV Morphine Consumption up to 48 Hours Post Surgery [ Time Frame: Four hour intervals for up to 48 hours ]
    Total IV morphine consumption during the first 0- 48 hours after surgery.Postoperative pain was treated with morphine PCA, ketorolac, oral oxycodone, and acetaminophen.

Secondary Outcome Measures :
  1. Time Until First PCA Demand Request [ Time Frame: every 4 hours up to 48 hours ]
    At 4-hour intervals for up to 48 hours IV PCA demands.

  2. Post-operative Pain Scores [ Time Frame: every 4 hours up to 48 hours ]

    Post-operative pain scores using Bieri faces scale every 4 hours up to 48 hours. Using Bieri faces pain scale. The faces show how much something can hurt. The "happy face" with a smile is no pain = 0 to faces showing more and more pain up 10. The space between two faces is scored 1, 3,5,7, or 9. to 10 (worst pain) will be used every 4 hours post-op for up to 48 hours.

    *Scores were not collected and/or included for all participants at all time points. If a patient was sleeping, there score was not recorded. If a patient completed the pain scale incorrectly (used an even number or included a range), then the data point was not included.

  3. Adverse Opioid Effect: Nausea [ Time Frame: every 4 hours up to 48 hours ]
    presence of nausea- dichotomous variable

  4. Adverse Opioid Effect: Emesis [ Time Frame: every 4 hours up to 48 hours ]
    presence of emesis- dichotomous variable

  5. Adverse Opioid Effect: Pruritus [ Time Frame: every 4 hours up to 48 hours ]
    presence of pruritus- dichotomous variable

  6. Adverse Opioid Effect: Respiratory Depression [ Time Frame: every 4 hours up to 48 hours ]
    presence of respiratory depression- dichotomous variable

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00880607

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United States, Colorado
The Children's Hospital- Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Mindy Cohen, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver Identifier: NCT00880607    
Other Study ID Numbers: 08-0721
Seed grant UCHSC ( Other Identifier: University of Colorado Department of Anesthesiology )
First Posted: April 14, 2009    Key Record Dates
Results First Posted: April 22, 2020
Last Update Posted: April 22, 2020
Last Verified: April 2020
Keywords provided by University of Colorado, Denver:
Spinal Fusion
pain management
Additional relevant MeSH terms:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents