Symptoms and General Pathology

All Conditions

Neoplasms

Behaviors and Mental Disorders

Rare Diseases

Pain

Pain, Procedural

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Quality of Life

Oculocerebral Syndrome With Hypopigmentation

Neuroepithelioma

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Ropivacaine

Propofol

Hypnotics and Sedatives

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Local

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

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

propofol

ropivacaine

Nurses will record patient-reported pain scores.

Wong-Baker FACES® Pain Rating Scale

Post-procedural quality of life (QOL)

Ellen Basu, MD, PhD

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.

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

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

Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm

Memorial Sloan Kettering Cancer Center

Participants received propofol \& ropivacaine in combination

Propofol and Ropivacaine

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

Propofol With Placebo First Then Propofol With Ropivacaine

ARM 2: 1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol

Propofol With Ropivacaine First Then Propofol With Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

United Kingdom

Region of Enrollment

Dr. Ellen Basu, MD, PhD

Require postprocedural opioid

Did not Require postprocedural opioid

Propofol Alone

Participants who received propofol \& ropivacaine

Propofol & Ropivacaine

Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm

Overall Study

Digestive System Diseases

Intestinal Diseases

Constipation

Cancer Pain

Gastrointestinal Diseases

Signs and Symptoms, Digestive

Gastrointestinal Agents

Other Dietary Supplements

Analgesics, Opioid

Benzocaine

Alvimopan

Tannic Acid

0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.

0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind.

A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.

0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.

Placebo was administered orally BID for 3 weeks.

alvimopan

placebo

GSK Clinical Trials, MD

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

GlaxoSmithKline

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients	NCT02924324	Neuroblastoma	propofol ropivacaine Wong-Baker FACE... Post-procedural...	3 Years - 18 Years	Memorial Sloan Kettering Cancer Center
Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication	NCT00101998	Constipation Bowel Dysfuncti...	alvimopan placebo	18 Years -	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients	NCT02924324	Neuroblastoma	propofol ropivacaine Wong-Baker FACE... Post-procedural...	3 Years - 18 Years	Memorial Sloan Kettering Cancer Center

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