Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

NCT01516684 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: IRB00017079NCI-2012-00019CCCWFU 01211
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Total Dose of Propofol Administered to Each Patient

  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.

  20 minutes after sedation

Secondary Outcomes (4)

• Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration

  At the time of LP insertion

• 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

  Within one week of the LP

• Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration

  20 minutes after lumbar puncture

• 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

  Within one week of the LP

Study Arms (2)

Arm I (EMLA)

EXPERIMENTAL

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

Drug: EMLA; Drug: propofol; Drug: fentanyl citrate

Arm II (placebo)

ACTIVE COMPARATOR

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

Drug: placebo administration; Drug: propofol; Drug: fentanyl citrate

Interventions

placebo administration DRUG

Given topically

Arm II (placebo)

EMLA DRUG

Given topically

Also known as: eutectic mixture of local anesthetics, lidocaine-prilocaine, lidocaine-prilocaine eutectic mixture

Arm I (EMLA)

propofol DRUG

Given IV

Also known as: Diprivan

Arm I (EMLA); Arm II (placebo)

fentanyl citrate DRUG

Given IV

Also known as: Actiq, Oralet, Sublimaze

Arm I (EMLA); Arm II (placebo)

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Lidocaine, Prilocaine Drug Combination; Propofol; Fentanyl

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Thomas McLean
• Organization: Wake Forest University Health Sciences

tmclean@wakehealth.edu

336-716-5440

Study Officials

• Dudley Hammon

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: May 14, 2012
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-08

Locations

US (1)