Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
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|ClinicalTrials.gov Identifier: NCT00880607|
Recruitment Status : Completed
First Posted : April 14, 2009
Results First Posted : April 22, 2020
Last Update Posted : April 22, 2020
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|
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 (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- 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.
- 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.
- 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.
- Adverse Opioid Effect: Nausea [ Time Frame: every 4 hours up to 48 hours ]presence of nausea- dichotomous variable
- Adverse Opioid Effect: Emesis [ Time Frame: every 4 hours up to 48 hours ]presence of emesis- dichotomous variable
- Adverse Opioid Effect: Pruritus [ Time Frame: every 4 hours up to 48 hours ]presence of pruritus- dichotomous variable
- Adverse Opioid Effect: Respiratory Depression [ Time Frame: every 4 hours up to 48 hours ]presence of respiratory depression- dichotomous variable
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 ClinicalTrials.gov identifier (NCT number): NCT00880607
|United States, Colorado|
|The Children's Hospital- Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Mindy Cohen, MD||University of Colorado, Denver|