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| Name | Class |
|---|---|
| Children's Hospital and Health System Foundation, Wisconsin | OTHER |
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Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also PCA morphine. The goal is to measure morphine usage and incidence of morphine side effects (pruritis, days foley, days to first stool, sedation, pain scores, PCA use).
Healthy, American Society of Anesthesia (ASA) 1-2 Idiopathic Scoliosis patients for spinal fusion.
Blinded, drug only known by hospital pharmacist. Study group 1- Gabapentin 15mg/kg with premed, 5/kg TID for 5 days of discharge, standard PCA morphine with dose and basal Study Group 2- Capsules resembling neurontin, with standard PCA morphine
No remifentanil, clonidine, ketamine
N=60 First patient enrolled 6/06 Last patient enrolled 7/15/08
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Gabapentin |
|
| 2 | Placebo Comparator | Placebo Comparator -- pill matched in appearance to gabapentin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | oral gabapentin in load pre-op (15mg/kg) and maintenance 5mg/kg TID for 5 days or discharge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Morphine Consumed (mg/kg/hr) | Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour. | PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour) |
| Amount of Morphine Consumed (mg/kg/hr) | Day 1 | |
| Amount of Morphine Consumed (mg/kg/hr) | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ondansetron Doses Administered for Nausea | The number of doses of Ondansetron given for nausea to participants in both groups. | First 10 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn M Rusy, MD | Medical College of Wisconsin | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin/Morphine | Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed. |
| FG001 | Placebo/Morphine | Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin/Morphine | Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed. |
| BG001 | Placebo/Morphine | Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amount of Morphine Consumed (mg/kg/hr) | Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour. | Posted | Mean | Standard Deviation | mg/kg/h | PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour) |
|
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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 | Gabapentin/Morphine | Gabapentin - group received gabapentin 3 times daily 5 mg/kg/dose. *Both groups received Morphine as needed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Rusy, MD | Medical College of Wisconsin | 414-266-2555 | lrusy@chw.org |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Placebo | Drug |
|
| Morphine | Drug | Administered as needed |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Amount of Morphine Consumed (mg/kg/hr) | Posted | Mean | Standard Deviation | mg/kg/h | Day 1 |
|
|
|
| Primary | Amount of Morphine Consumed (mg/kg/hr) | Posted | Mean | Standard Deviation | mg/kg/h | Day 2 |
|
|
|
| Secondary | Number of Ondansetron Doses Administered for Nausea | The number of doses of Ondansetron given for nausea to participants in both groups. | Posted | Median | Inter-Quartile Range | doses of medication administered | First 10 days after surgery |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Placebo/Morphine | Placebo Comparator - group received placebo 3 times daily. *Both groups received Morphine as needed. | 0 | 30 | 0 | 30 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |