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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Lumbar Puncture, Topical Analgesia

In brief

The purpose of this study is to evaluate the effectiveness of a needle-free jet-injection system with 1% buffered lidocaine for local anesthesia for lumbar punctures compared to a topical anesthetic agent. Our hypothesis is: A needle-free jet-injection system (J-Tip) with 1% lidocaine will provide local anesthesia that is comparable to that of a topical anesthetic agent (EMLA cream) when performing lumbar punctures in children.

Key facts

Study ID

NCT01628874

Run by

University of Colorado, Denver

People needed

66

Starts

2012-09-01

Expected to finish

2016-08-01

Last updated by the study team

2019-06-21

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age ≤4 months or 4-18 years
• ability to report VAS for patients 4-18 years
• require lumbar puncture as part of their clinical care

You may not qualify if…

• ages 5-47 months
• developmental delay or inability to complete VAS in older patients
• allergy to lidocaine
• requirement of sedation for procedure
• pre-procedural analgesia treatment except for nonsteroidal anti-inflammatory drugs and acetaminophen.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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