N/A
N=56
Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients
Neuroblastoma
Bottom Line
View on ClinicalTrials.gov: NCT02924324 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm — 22; 22; 34; 34 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- propofol (Device); ropivacaine (Drug); Wong-Baker FACES® Pain Rating Scale (Behavioral); Post-procedural quality of life (QOL) (Behavioral)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm |
22; 22; 34; 34 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02924324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.