Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-14

Study Completion Date

2018-06-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures

NCT04003012

Leukemia-Lymphoma

COMPLETED PHASE4

Evaluation of the Analgesy With Emla and/or Nitrous Oxide in Pediatric Patients for Lumbar Puncture

NCT00808171

Leukemia Non Hodgkin Lymphoma

COMPLETED PHASE4

Jet Injection of 1% Buffered Lidocaine Versus Topical EMLA for Local Anesthesia Before Lumbar Puncture in Children

NCT01628874

Lumbar Puncture Topical Analgesia

TERMINATED NA

Anesthesia Lumbar Puncture In Children

NCT02590705

Spinal Puncture Anesthesia

UNKNOWN NA

Pain Perception During Vulvar Biopsy

NCT03654417

Any Condition Requiring Vulvar Biopsy

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (EMLA)

Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

Group Type EXPERIMENTAL

EMLA

Intervention Type DRUG

Given topically

propofol

Intervention Type DRUG

Given IV

fentanyl citrate

Intervention Type DRUG

Given IV

Arm II (placebo)

Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

Group Type ACTIVE_COMPARATOR

placebo administration

Intervention Type DRUG

Given topically

propofol

Intervention Type DRUG

Given IV

fentanyl citrate

Intervention Type DRUG

Given IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

placebo administration

Given topically

Intervention Type DRUG

EMLA

Given topically

Intervention Type DRUG

propofol

Given IV

Intervention Type DRUG

fentanyl citrate

Given IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

eutectic mixture of local anesthetics lidocaine-prilocaine lidocaine-prilocaine eutectic mixture Diprivan Actiq Oralet Sublimaze

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No