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NCT01516684 · ClinicalTrials.gov registry record · Phase 2
Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT01516684: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT01516684 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01516684, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary
Primary Outcome
Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.
Interventions
- DRUG propofol
- DRUG placebo administration
- DRUG EMLA
- DRUG fentanyl citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-05-14 |
| Est. Completion | 2018-06-26 |
| Phase | Phase 2 |
What the finished NCT01516684 record still lists
NCT01516684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which propofol is the first listed.
NCT01516684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01516684 about?
NCT01516684 is a clinical study titled "Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures". This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary
What is the current status of trial NCT01516684?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2012-05-14. Estimated completion is 2018-06-26.
What interventions are being tested in trial NCT01516684?
The interventions under investigation include: propofol (DRUG), placebo administration (DRUG), EMLA (DRUG), fentanyl citrate (DRUG).
Who is sponsoring clinical trial NCT01516684?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01516684's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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