The Use of Intraoperative Intrathecal Morphine Versus Epidural Extended Release Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion (IT Morphine)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Children's Hospital Colorado.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by:
Children's Hospital Colorado
ClinicalTrials.gov Identifier:
NCT00880607
First received: April 10, 2009
Last updated: May 20, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Pain Management
Spinal Fusion
Scoliosis
Drug: DepoDur™
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Colorado:

Primary Outcome Measures:
  • 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 [ Time Frame: 60 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Usual care
Experimental: 2
Receives DepoDur (morphine) for pain management
Drug: DepoDur™
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.

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

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880607

Contacts
Contact: Mindy Cohen, MD 720-777-6886 mindy.cohen@ucdenver.edu
Contact: Jeffrey Galinkin, MD 720-777-6226 jeffrey.galinkin@ucdenver.edu

Locations
United States, Colorado
The Children's Hospital- Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Mindy Cohen, MD    303-331-6871    mindy.cohen@ucdenver.edu   
Contact: Jeffrey Galinkin, MD    720-777-6226    jeffrey.galinkin@ucdenver.edu   
Sponsors and Collaborators
Children's Hospital Colorado
University of Colorado, Denver
Investigators
Principal Investigator: Mindy Cohen, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: Mindy Cohen, MD, University of Colorado- Denver
ClinicalTrials.gov Identifier: NCT00880607     History of Changes
Other Study ID Numbers: 08 0721, Seed grant UCHSC
Study First Received: April 10, 2009
Last Updated: May 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Colorado:
Pain
Pediatric
Spinal Fusion
pain management

Additional relevant MeSH terms:
Pain, Postoperative
Scoliosis
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 20, 2014