NCT01516684

Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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

Detailed description

PRIMARY OBJECTIVES: I. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to application of a topical placebo cream. SECONDARY OBJECTIVES: I. To determine whether the use of EMLA cream decreases complication rates from sedation. II. To determine whether the use of EMLA cream decreases traumatic lumbar punctures. III. To determine whether the use of EMLA cream shortens recovery time. IV. To determine practitioner and parent satisfaction with the use of EMLA cream. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol. ARM II: Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol. After completion of study treatment, patients are followed up within 1 week.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	placebo administration	Given topically
DRUG	EMLA	Given topically
DRUG	propofol	Given IV
DRUG	fentanyl citrate	Given IV

Timeline

• Start date: 2012-05-14
• Primary completion: 2018-06-26
• Completion: 2018-06-26
• First posted: 2012-01-25
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study