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There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.
Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naloxone infusion 0.5 mcg/kg/hr | Active Comparator |
| |
| Naloxone 2.5 mcg/kg/hr | Experimental | Naloxone infusion 2.5 mcg/kg/hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxone | Drug | Naloxone infusion 0.5 mcg/kg/hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hours Until Tolerating Oral Intake | Defined as time when awakening after surgery until tolerating orals. | Assessed daily in hospital while in hospital until taking orals, average 4 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Itching | Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome. Title of scale "Itching VAS". Scores were assessed daily for 5 days and an average of the five days was reported. | Assessed daily while in hospital requiring PCA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin J. Pieters, DO | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone: Naloxone infusion 0.5 mcg/kg/hr |
| FG001 | Naloxone 2.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone: Naloxone infusion 0.5 mcg/kg/hr |
| BG001 | Naloxone 2.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr |
| 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 | Number of Hours Until Tolerating Oral Intake | Defined as time when awakening after surgery until tolerating orals. | Posted | Median | Inter-Quartile Range | hours | Assessed daily in hospital while in hospital until taking orals, average 4 days. |
|
|
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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 | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone: Naloxone infusion 0.5 mcg/kg/hr | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ben Pieters | Children's Mercy Hospital | 816-234-3464 | bjpieters@cmh.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Naloxone | Drug | Naloxone infusion 2.5 mcg/kg/hr |
|
|
| Severity of Nausea | Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome. Name of scale "Nausea VAS". Scores were assessed daily for 5 days and an average of the five days reported. | Assessed daily while in hospital requiring PCA. |
| Severity of Pain | Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum. Name of scale "Pain VAS". Scores were assessed daily for 5 days and an average of the five days was reported. | Assessed by bedside nurse 3 times daily while requiring PCA |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Severity of Itching | Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome. Title of scale "Itching VAS". Scores were assessed daily for 5 days and an average of the five days was reported. | Posted | Median | Inter-Quartile Range | score on a scale, averaged | Assessed daily while in hospital requiring PCA |
|
|
|
| Secondary | Severity of Nausea | Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome. Name of scale "Nausea VAS". Scores were assessed daily for 5 days and an average of the five days reported. | Posted | Median | Inter-Quartile Range | score on a scale, averaged | Assessed daily while in hospital requiring PCA. |
|
|
|
| Secondary | Severity of Pain | Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum. Name of scale "Pain VAS". Scores were assessed daily for 5 days and an average of the five days was reported. | Posted | Median | Inter-Quartile Range | units on a scale, averaged | Assessed by bedside nurse 3 times daily while requiring PCA |
|
|
|
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Naloxone 2.5 mcg/kg/hr | Naloxone infusion 2.5 mcg/kg/hr Naloxone: Naloxone infusion 2.5 mcg/kg/hr | 0 | 42 | 0 | 42 | 0 | 42 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| 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 |