CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
placebo administration +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01516684
NCT01516684Phase 2Completed
CompareCT.gov

A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream

Wake Forest University Health Sciences·interventional·Posted Jan 25, 2012·Updated Sep 6, 2019

In Brief

A Phase 2 clinical trial evaluating placebo administration, EMLA, and 2 other interventions for Malignant Neoplasm. Completed, enrolled 33 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Neoplasm
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 25, 2012
Enrollment StartMay 14, 2012
Primary CompletionJun 26, 2018
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 14.4 years ago

Interventions

placebo administrationdrug

Given topically

EMLAdrug

Given topically

propofoldrug

Given IV

fentanyl citratedrug

Given IV