The Effectiveness of a Pediatric Lumbar Puncture Restraint Device

University of Nebraska30 enrolled

Overview

This is a pilot study to evaluate a restraint device for lumbar punctures. Designed to help improve the restraint techniques for lumbar puncture, the restraint device will be compared to the current standard of manual physical restraint in neonatal and pediatric patients (age 1 day to 90 days of life). The investigators will study 30 subjects, with 20 randomized for the experimental device and 10 randomized for the "control" group, which is current standard of care. The investigators' primary outcomes will include time of procedure, red blood cells in the cerebrospinal fluid as well as physician satisfaction. Subjects will be eligible if they are 1-90 days of life, and their treating physician believes lumbar puncture is indicated. There is no follow-up once the lumbar puncture has been completed and the data has been obtained.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Indication for Lumbar Puncture

Interventions

Eligibility

Sex: ALLMin age: 1 DayMax age: 90 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Age 1 to 90 days of life * Indication for lumbar puncture procedure as determined by the treating physician * Informed Consent from the subject's legal guardian indicating their acceptance of a lumbar puncture for the work-up of sepsis * Informed consent to enrolled in said protocol Exclusion Criteria: * No indication for lumbar puncture procedure as determined by treating physician

Outcomes

Primary Outcomes

To evaluate the safety of the lumbar puncture restraint board

Time frame: one time use

Secondary Outcomes

To evaluate the effect of the restraint board on the quality of the procedure (time of procedure, quality of specimen obtained, physician impression)

Time frame: One time use