NCT01224431

Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Phoenix Children's Hospital · Academic / Other
• Sex: All
• Age: 90 Days
• Healthy volunteers: Not accepted

Summary

Background: The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants. Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture.

Detailed description

Background: Lumbar puncture is an essential procedure in the emergency department for the evaluation of meningitis. Subcutaneous injection of lidocaine prior to lumbar puncture for local anesthesia is not a pain free procedure. The J-Tip Device allows an intradermal needle-free jet injection of 1% buffered lidocaine. This study compares needle-free jet injection of lidocaine to saline in reducing pain prior to lumbar puncture in infants. Methods: Randomized, double-blinded, placebo controlled trial involving infants, less than 3 months of age, presenting to the emergency department meeting clinical criteria for a lumbar puncture. All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions as well as crying times were video recorded from start to finish. Independent reviewers assigned pain scores based on the validated Neonatal Facial Coding System with possible scores ranging from 0-5.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Buffered Lidocaine J-tip	All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-10-20
• Last updated: 2018-10-23
• Results posted: 2011-06-14

Locations

1 site across 1 country: United States