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

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

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis; Pain Management; Spinal Fusion
• Intervention / Treatment: Drug: Intrathecal morphine; Drug: Extended Release Epidural Morphine

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • The Children's Hospital- Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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: DepoDur; EREM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Until First PCA Demand Request	At 4-hour intervals for up to 48 hours IV PCA demands.	every 4 hours up to 48 hours
Post-operative Pain Scores	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.	every 4 hours up to 48 hours
Adverse Opioid Effect: Nausea	presence of nausea- dichotomous variable	every 4 hours up to 48 hours
Adverse Opioid Effect: Emesis	presence of emesis- dichotomous variable	every 4 hours up to 48 hours
Adverse Opioid Effect: Pruritus	presence of pruritus- dichotomous variable	every 4 hours up to 48 hours
Adverse Opioid Effect: Respiratory Depression	presence of respiratory depression- dichotomous variable	every 4 hours up to 48 hours

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Mindy Cohen, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: April 10, 2009
• First Submitted That Met QC Criteria: April 13, 2009
• First Posted (ESTIMATE): April 14, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Pediatric; pain management; Spinal Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 08-0721; Seed grant UCHSC (OTHER: University of Colorado Department of Anesthesiology)