Trial Outcomes & Findings for Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain (NCT NCT01606150)
NCT ID: NCT01606150
Last Updated: 2016-12-13
Results Overview
Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000
TERMINATED
NA
5 participants
immediately following the procedure
2016-12-13
Participant Flow
Participant milestones
| Measure |
Subcutaneous Lidocaine
0.1 ml/kg of 1% Lidocaine
1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure
|
Topical Lidocaine
LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure
topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: immediately following the procedureSuccess defined as cerebrospinal fluid for a culture and red blood cell count less than 1000
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: data collected during the procedure, PIPP score assigned within one month by viewing collected dataPIPP score assigned by a blinded outcome assessor by viewing video tapes of the infant's face during the procedure and vital sign changes during that time frame
Outcome measures
Outcome data not reported
Adverse Events
Subcutaneous Lidocaine
Topical Lidocaine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Judith Palafoutas, Research Director
Georgetown University NICU
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place