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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Neuroblastoma

Treatments: Behavioral: Post-procedural quality of life (QOL); Device: propofol; Drug: ropivacaine; Behavioral: Wong-Baker FACES® Pain Rating Scale

Study type: Interventional

Funder types: Other

Identifiers

NCT02924324

16-1417

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Propofol First, then Propofol & Ropivacaine

Active Comparator group

Description:

1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine

Treatment:

Behavioral: Wong-Baker FACES® Pain Rating Scale

Device: propofol

Behavioral: Post-procedural quality of life (QOL)

Propofol and Ropivacaine First, then Propofol

Experimental group

Description:

1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol

Treatment:

Behavioral: Wong-Baker FACES® Pain Rating Scale

Drug: ropivacaine

Behavioral: Post-procedural quality of life (QOL)