Phase 2 N=33 Randomized Double-blind Supportive Care

Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

Malignant Neoplasm

Bottom Line

View on ClinicalTrials.gov: NCT01516684 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Total Dose of Propofol Administered to Each Patient — 2.94; 3.22 mg/kg — p=0.036

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: placebo administration (Drug); EMLA (Drug); propofol (Drug); fentanyl citrate (Drug)
Age: Pediatric, Adult
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Dose of Propofol Administered to Each Patient	2.94; 3.22	0.036 sig
SECONDARY Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration	50; 29; 7; 12; 8; 27	—
SECONDARY Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream	0.194; 0.289	0.094
SECONDARY Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration	63; 57; 6; 5; 1; 4	0.382
SECONDARY Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream	0.211; 0.250	0.426

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

Eligibility Criteria

Inclusion Criteria

Pediatric oncology patients undergoing a lumbar puncture in the Pediatric Sedation Suite; patients may or may not be receiving intrathecal chemotherapy

Exclusion Criteria

Patients undergoing additional procedures during the same anesthetic such as bone marrow aspirate or biopsy will be excluded because they will likely require higher doses of propofol than those undergoing LP alone Patients who are allergic to or not tolerant of EMLA cream, propofol, or fentanyl will be excluded Patients who are pregnant will be excluded Patients having their LPs done by students will be excluded

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Data sourced from ClinicalTrials.gov (NCT01516684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.