Trial Outcomes & Findings for Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients (NCT NCT02924324)
NCT ID: NCT02924324
Last Updated: 2022-11-08
Results Overview
Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
within 24 hours (+/- 4 hours) post procedure
Results posted on
2022-11-08
Participant Flow
Participant milestones
| Measure |
Propofol With Placebo First Then Propofol With Ropivacaine
ARM 1: 1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine
|
Propofol With Ropivacaine First Then Propofol With Placebo
ARM 2: 1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients
Baseline characteristics by cohort
| Measure |
Propofol With Placebo First Then Propofol With Ropivacaine
n=28 Participants
ARM 1: 1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol \& ropivacaine
|
Propofol With Ropivacaine First Then Propofol With Placebo
n=28 Participants
ARM 2: 1st BM procedure: Intervention B: propofol \& ropivacaine first. Then second BM procedure with propofol
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.75 years
n=99 Participants
|
6.5 years
n=107 Participants
|
7.13 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within 24 hours (+/- 4 hours) post procedureNumber of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm
Outcome measures
| Measure |
Propofol Alone
n=56 Participants
Participants who received propofol alone
|
Propofol & Ropivacaine
n=56 Participants
Participants who received propofol \& ropivacaine
|
|---|---|---|
|
Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm
Require postprocedural opioid
|
22 participants
|
22 participants
|
|
Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm
Did not Require postprocedural opioid
|
34 participants
|
34 participants
|
Adverse Events
Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Propofol and Ropivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ellen Basu, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5204
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place