Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224431
• Other study ID #: 09-014
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2018
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Blake Bulloch/PhoenixChildren's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ferayorni A, Yniguez R, Bryson M, Bulloch B. Needle-free jet injection of lidocaine for local anesthesia during lumbar puncture: a randomized controlled trial. Pediatr Emerg Care. 2012 Jul;28(7):687-90. doi: 10.1097/PEC.0b013e31825d210b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, Measured as Units on a Scale	Pain scores at time of needle insertion using neonatal facial coding score. The scale has five components; cry, brow bulge, eye squeeze; nasolabial fold and open month. Each component is either present or absent, with a value of 0 or 1 given. Minimum score of 0 and a maximum score of 5 possible	on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure.
Secondary	Length of Cry	cry video recorded and measured after needle stick until pt stopped crying	On average the first hour in the emergency department; from needle stick to end of lumbar puncture