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| ID | Type | Description | Link |
|---|---|---|---|
| Seed grant UCHSC | Other Identifier | University of Colorado Department of Anesthesiology |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal morphine | Active Comparator | Receives a single dose of intrathecal morphine |
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| Extended Release Epidural Morphine | Experimental | Receives DepoDur extended release epidural morphine for pain management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal morphine | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mindy Cohen, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital- Denver | Aurora | Colorado | 80045 | United States |
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84 patients consented to participate. 3 patients did not start the study due to physician discretion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrathecal Morphine | Receives a single dose of intrathecal morphine 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. |
| FG001 | DepoDur |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Extended Release Epidural Morphine | 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. |
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| 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 |
Receives DepoDur extended release morphine for pain management 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. |
| Observation After Receiving Medication |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrathecal Morphine | Receives a single dose of intrathecal morphine 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. |
| BG001 | DepoDur | Receives DepoDur extended release morphine for pain management 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control. | Posted | Median | 95% Confidence Interval | mg | Four hour intervals for up to 48 hours |
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| Secondary | Time Until First PCA Demand Request | At 4-hour intervals for up to 48 hours IV PCA demands. | Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control. | Posted | Median | 95% Confidence Interval | hours | every 4 hours up to 48 hours |
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| 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. | Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control. | Posted | Mean | Standard Error | units on a scale | every 4 hours up to 48 hours |
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| Secondary | Adverse Opioid Effect: Nausea | presence of nausea- dichotomous variable | Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control. | Posted | Number | percentage of patients with nausea | every 4 hours up to 48 hours |
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| Secondary | Adverse Opioid Effect: Emesis | presence of emesis- dichotomous variable | Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control. | Posted | Number | percentage of patients with emesis | every 4 hours up to 48 hours |
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| Secondary | Adverse Opioid Effect: Pruritus | presence of pruritus- dichotomous variable | Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control. | Posted | Number | percentage of patients with pruritus | every 4 hours up to 48 hours |
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| Secondary | Adverse Opioid Effect: Respiratory Depression | presence of respiratory depression- dichotomous variable | Intent to treat pediatric patients between 8-17 years of age undergoing thoracolumbar posterior spinal fusion with either Intrathecal morphine versus extended-release epidural morphine for post operative pain control. | Posted | Number | % patients with respiratory depression | every 4 hours up to 48 hours |
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Immediately Post Op to 48 hours after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intrathecal Morphine | Receives a single dose of intrathecal morphine 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. | 0 | 37 | 0 | 37 | 0 | 37 |
| EG001 | DepoDur | Receives DepoDur extended release morphine for pain management 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. | 0 | 34 | 0 | 34 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mindy Cohen, MD FAAP, Assistant Professor, Department of Anesthesiology | Children's Hospital of Colorado, University of Colorado | Mindy.cohen@childrenscolorado.org |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D012600 | Scoliosis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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