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

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924324
• Other study ID #: 16-1417
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 2019

Study information

• Verified date: October 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Device:
• propofol

Drug:
• ropivacaine

Behavioral:
• Wong-Baker FACES® Pain Rating Scale
Nurses will record patient-reported pain scores.
• Post-procedural quality of life (QOL)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center