NeuroblastomaNCT02924324
Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients
A study testing propofol, ropivacaine and Wong-Baker FACES® Pain Rating Scale in people with Neuroblastoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- propofol, ropivacaine and Wong-Baker FACES® Pain Rating Scale
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
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.
- Conditions
- Neuroblastoma
- Being tested
- propofol, ropivacaine, Wong-Baker FACES® Pain Rating Scale, Post-procedural quality of life (QOL)
- Keywords
- local Injection, pain Medication, propofol, ropivacaine, 16-1417
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDevice
ropivacaineDrug
Wong-Baker FACES® Pain Rating ScaleBehavioural
Nurses will record patient-reported pain scores.
Post-procedural quality of life (QOL)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Propofol First, then Propofol & Ropivacaine | Active comparator | 1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine Receives: Device: propofol; Behavioral: Wong-Baker FACES® Pain Rating Scale; Behavioral: Post-procedural quality of life (QOL) |
| Propofol and Ropivacaine First, then Propofol | Experimental | 1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol Receives: Drug: ropivacaine; Behavioral: Wong-Baker FACES® Pain Rating Scale; Behavioral: Post-procedural quality of life (QOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 24 hours (+/- 4 hours) post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Basu, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924324
- Sponsor's protocol ID
- 16-1417
- Status last verified
- Oct 2021
- First submitted
- 3 Oct 2016
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Zarnegar-Lumley S, Lange KR, Mathias MD, Nakajima-Hatano M, Offer KM, Ogu UO, Ortiz MV, Tan KS, Kellick M, Modak S, Roberts SS, Basu EM, Dingeman RS. Local Anesthesia With General Anesthesia for Pediatric Bone Marrow Procedures. Pediatrics. 2019 Aug;144(2):e20183829. doi: 10.1542/peds.2018-3829.
PubMed 31366683
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02924324
- Acronym / sponsor ID
- 16-1417
- Conditions
- Neuroblastoma
- Keywords
- local Injection, pain Medication, propofol, ropivacaine, 16-1417
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Posted 26 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol First, then Propofol & Ropivacaine | Active comparator | Device: propofol, Behavioral: Wong-Baker FACES® Pain Rating Scale, Behavioral: Post-procedural quality of life (QOL)1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine |
| Propofol and Ropivacaine First, then Propofol | Experimental | Drug: ropivacaine, Behavioral: Wong-Baker FACES® Pain Rating Scale, Behavioral: Post-procedural quality of life (QOL)1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol | Device | Propofol First, then Propofol & Ropivacaine |
| ropivacaine | Drug | Propofol and Ropivacaine First, then Propofol |
| Wong-Baker FACES® Pain Rating ScaleNurses will record patient-reported pain scores. | Behavioural | Propofol First, then Propofol & Ropivacaine, Propofol and Ropivacaine First, then Propofol |
| Post-procedural quality of life (QOL) | Behavioural | Propofol First, then Propofol & Ropivacaine, Propofol and Ropivacaine First, then Propofol |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31366683Zarnegar-Lumley S, Lange KR, Mathias MD, Nakajima-Hatano M, Offer KM, Ogu UO, Ortiz MV, Tan KS, Kellick M, Modak S, Roberts SS, Basu EM, Dingeman RS. Local Anesthesia With General Anesthesia for Pediatric Bone Marrow Procedures. Pediatrics. 2019 Aug;144(2):e20183829. doi: 10.1542/peds.2018-3829.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Basu, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol, ropivacaine and Wong-Baker FACES® Pain Rating Scale in people with Neuroblastoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm (time frame: within 24 hours (+/- 4 hours) post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.