Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients

Study Overview
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Brief Summary
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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.

Official Title
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RePPAIR -Reducing Procedural Pain and Improving Recovery of Quality of Life in Pediatric Neuroblastoma Patients Undergoing Bone Marrow Procedures: A Prospective Randomized Cross-over Clinical Trial

Conditions
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Neuroblastoma

Intervention / Treatment
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* Device: propofol
* Drug: ropivacaine
* Behavioral: Wong-Baker FACES® Pain Rating Scale
* Behavioral: Post-procedural quality of life (QOL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol First, then Propofol & Ropivacaine<br>1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine | Device: propofol<br> <br> Behavioral: Wong-Baker FACES® Pain Rating Scale<br>* Nurses will record patient-reported pain scores.<br>Behavioral: Post-procedural quality of life (QOL)<br> <br> |
| Experimental: Propofol and Ropivacaine First, then Propofol<br>1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol | Drug: ropivacaine<br> <br> Behavioral: Wong-Baker FACES® Pain Rating Scale<br>* Nurses will record patient-reported pain scores.<br>Behavioral: Post-procedural quality of life (QOL)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local Injection, pain Medication, propofol, ropivacaine, 16-1417