Neuroblastoma
Conditions
Keywords
local Injection, pain Medication, propofol, ropivacaine, 16-1417
Brief summary
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.
Interventions
DEVICEpropofol
DRUGropivacaine
BEHAVIORALWong-Baker FACES® Pain Rating Scale
Nurses will record patient-reported pain scores.
BEHAVIORALPost-procedural quality of life (QOL)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRGSS)22 * 3 - 18 years of age * Patient has had prior bone marrow procedures * English speaking
Exclusion criteria
* History of allergy to investigational agent: ropivacaine or other amino amide analgesics * History of allergy to standard agent: propofol * Chronic daily opioid requirement * Lansky/Karnofsky Score \< 60 * Inability to comply with protocol requirements including refusal to forego pre-procedural opioid use * Patient is receiving additional potentially painful interventions (e.g. central line insertion/removal) concurrent with the bone marrow procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm | within 24 hours (+/- 4 hours) post procedure | Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 28 |
| Propofol With Ropivacaine First Then Propofol With Placebo ARM 2: 1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Propofol With Placebo First Then Propofol With Ropivacaine | Total | Propofol With Ropivacaine First Then Propofol With Placebo |
|---|---|---|---|
| Age, Continuous | 7.75 years | 7.13 years | 6.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 55 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 42 Participants | 19 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 28 Participants | 55 Participants | 27 Participants |
| Sex: Female, Male Female | 13 Participants | 20 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 36 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 56 | 12 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
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
Time frame: within 24 hours (+/- 4 hours) post procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Propofol Alone | Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm | Require postprocedural opioid | 22 participants |
| Propofol Alone | Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm | Did not Require postprocedural opioid | 34 participants |
| Propofol & Ropivacaine | Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm | Require postprocedural opioid | 22 participants |
| Propofol & Ropivacaine | Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm | Did not Require postprocedural opioid | 34 participants |