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The purpose of this study is to identify whether or not the addition of a numbing medicine that is injected directly into the site of the bone marrow procedure can reduce pain and the use of opioid pain medication after bone marrow procedures. The addition of this medicine, called ropivacaine, is the experimental part of this study. This is the first time ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol First, then Propofol & Ropivacaine | Active Comparator | 1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine |
|
| Propofol and Ropivacaine First, then Propofol | Experimental | 1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Device |
| ||
| ropivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm | Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm | within 24 hours (+/- 4 hours) post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Basu, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31366683 | Derived | Zarnegar-Lumley S, Lange KR, Mathias MD, Nakajima-Hatano M, Offer KM, Ogu UO, Ortiz MV, Tan KS, Kellick M, Modak S, Roberts SS, Basu EM, Dingeman RS. Local Anesthesia With General Anesthesia for Pediatric Bone Marrow Procedures. Pediatrics. 2019 Aug;144(2):e20183829. doi: 10.1542/peds.2018-3829. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol With Placebo First Then Propofol With Ropivacaine | ARM 1: 1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine |
| FG001 | Propofol With Ropivacaine First Then Propofol With Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2018 |
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|
| Wong-Baker FACES® Pain Rating Scale | Behavioral | Nurses will record patient-reported pain scores. |
|
| Post-procedural quality of life (QOL) | Behavioral |
|
ARM 2: 1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol With Placebo First Then Propofol With Ropivacaine | ARM 1: 1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine |
| BG001 | Propofol With Ropivacaine First Then Propofol With Placebo | ARM 2: 1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 Participants Requiring Post-procedural Opioid Analgesia Per Study Arm | Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm | Posted | Number | participants | within 24 hours (+/- 4 hours) post procedure |
|
|
|
Up to 1 year
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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 | Propofol | Participants received propofol alone | 12 | 56 | 0 | 56 | 0 | 56 |
| EG001 | Propofol and Ropivacaine | Participants received propofol & ropivacaine in combination | 12 | 56 | 0 | 56 | 0 | 56 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ellen Basu, MD, PhD | Memorial Sloan Kettering Cancer Center | 212-639-5204 | BasuE@mskcc.org |
| Aug 6, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United Kingdom |
|