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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880607
• Other study ID #: 08-0721
• Secondary ID: Seed grant UCHSC
• Status: Completed
• Phase: Phase 4
• Start date: December 2008
• Est. completion date: September 2012

Study information

• Verified date: April 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Management
• Scoliosis
• Spinal Fusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Children's Hospital- Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Adverse Opioid Effect: Nausea	presence of nausea- dichotomous variable	every 4 hours up to 48 hours
Secondary	Adverse Opioid Effect: Emesis	presence of emesis- dichotomous variable	every 4 hours up to 48 hours
Secondary	Adverse Opioid Effect: Pruritus	presence of pruritus- dichotomous variable	every 4 hours up to 48 hours
Secondary	Adverse Opioid Effect: Respiratory Depression	presence of respiratory depression- dichotomous variable	every 4 hours up to 48 hours