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

NCT ID: NCT00880607

Last Updated: 2020-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-09-30

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.

Conditions

Pain Management; Spinal Fusion; Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intrathecal morphine

Receives a single dose of intrathecal morphine

Group Type: ACTIVE_COMPARATOR

Intrathecal morphine

Intervention Type: DRUG

Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.

Extended Release Epidural Morphine

Receives DepoDur extended release epidural morphine for pain management

Group Type: EXPERIMENTAL

Extended Release Epidural Morphine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

IT Morphine; EREM; DepoDur

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mindy Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

The Children's Hospital- Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

Seed grant UCHSC

Identifier Type: OTHER

Identifier Source: secondary_id

08-0721

Identifier Type: -

Identifier Source: org_study_id