"Lidocaine 4% Cream (LMX4) vs Placebo for Pain Due to Lumbar Puncture in Infants 0-60 Days of Age."

NCT00533468 | Completed Phase 4 Results DMC

• 1 other identifier: 05-130
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The study's hypothesis is LMX4 cream, a topical anesthetic cream, will reduce the pain of infants undergoing Lumbar Puncture (spinal tap).

Conditions

Pain

Keywords

pain; lumbar puncture; neonates; infants; emergency department; topical anesthesia; LMX4

Outcome Measures

Primary Outcomes (1)

• Neonatal Facial Coding System Score

  10 measures of pain, all scored 0 or 1, high score means more pain. No pain would be recorded as zero, maximum pain recorded as 10

  Score was measured at baseline, upon positioning for the procedure, immediately prior to needle insertion, during needle insertion, 1 minute post-needle insertion, and post-procedure when the infant had recovered from the procedure and was swaddled

Secondary Outcomes (2)

• Time of Procedure

  Infant's stay in the Emergency Department

• Percentage of Procedures With Success

  During patient's Emergency Department Stay

Study Arms (2)

Active Drug

EXPERIMENTAL

Active 4% Lidocaine topical cream (LMX4 cream) applied under occlusive dressing

Drug: Lidocaine Cream 4%

Placebo

PLACEBO COMPARATOR

Placebo Cream made on same run at factory but without active Lidocaine 4% drug

Drug: Placebo

Interventions

Lidocaine Cream 4% DRUG

Topical cream, 2g applied under occlusive dressing for 20 minutes prior to the procedure

Also known as: LMX4

Active Drug

Placebo DRUG

inactive placebo without LMX4

Placebo

Eligibility Criteria

• Age: 0 Days - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full term (\>=37 weeks gestation)
• Age 0-60 Days
• Undergoing Lumbar Puncture

You may not qualify if:

• Unstable
• Premature (\<37 weeks gestation)
• Allergy to study medicine
• Parent refusal of consent

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Ferndale Laboratories, Inc.: collaborator

Study Sites (1)

Women's and Children's Hospital of Buffalo

Buffalo, New York, 14222, United States

Location

MeSH Terms

Conditions

Pain; Emergencies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Limitations and Caveats

Significant technical limitation was encountered regarding videotaping of infant faces when properly positioned for the procedure, as the research assistant had to be underneath the nurse's arm with the camera adjacent to the nurse's breast. This resulted in many exclusions of patients enrolled by the male research assistants as the camera was not in proper position. The many exclusions reduced the study's power to reach a statistically significant difference.

Results Point of Contact

• Title: Dr James Reingold
• Organization: Children's Hospital of Philadelphia

reingoldj@email.chop.edu

6027516093

Study Officials

• James L Reingold, MD

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 21, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-11

Locations

US (1)