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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-11-30

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.

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Detailed Description

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Conditions

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Neuroblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol First, then Propofol & Ropivacaine

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

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DEVICE

Wong-Baker FACES® Pain Rating Scale

Intervention Type BEHAVIORAL

Nurses will record patient-reported pain scores.

Post-procedural quality of life (QOL)

Intervention Type BEHAVIORAL

Propofol and Ropivacaine First, then Propofol

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

Group Type EXPERIMENTAL

ropivacaine

Intervention Type DRUG

Wong-Baker FACES® Pain Rating Scale

Intervention Type BEHAVIORAL

Nurses will record patient-reported pain scores.

Post-procedural quality of life (QOL)

Intervention Type BEHAVIORAL

Interventions

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propofol

Intervention Type DEVICE

ropivacaine

Intervention Type DRUG

Wong-Baker FACES® Pain Rating Scale

Nurses will record patient-reported pain scores.

Intervention Type BEHAVIORAL

Post-procedural quality of life (QOL)

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No