Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Phoenix Children's Hospital

Status: Completed

Conditions: Pain

Treatments: Drug: Buffered Lidocaine J-tip

Study type: Interventional

Funder types: Other

Identifiers

NCT01224431

09-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 90 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• fever in infants less than 3 months

Exclusion criteria

• toxic appearance, altered level of consciousness, age greater than 3 months or less than 4kg of weight

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Buffered lidocaine J-tip

Experimental group

Description:

Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline)

Treatment:

Drug: Buffered Lidocaine J-tip

Normal saline J-tip

Placebo Comparator group

Description:

Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine

Treatment:

Drug: Buffered Lidocaine J-tip