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OpenTrials
Completed

NCT Number: NCT02924324

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

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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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

propofol

Device

Ropivacaine

Drug

Wong-Baker FACES® Pain Rating Scale

Behavioral

Nurses will record patient-reported pain scores.

Post-procedural quality of life (QOL)

Behavioral

Primary outcomes

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

    Time frame: within 24 hours (+/- 4 hours) post procedure

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 5, 2016
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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