Needle-Free Jet Injection of Lidocaine During Lumbar Puncture

NCT01224431 | Completed Results

• 1 other identifier: 09-014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

pain; lidocaine; lumbar puncture; j-tip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Length of Cry

  On average the first hour in the emergency department; from needle stick to end of lumbar puncture

Study Arms (2)

Buffered lidocaine J-tip

EXPERIMENTAL

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

Drug: Buffered Lidocaine J-tip

Normal saline J-tip

PLACEBO COMPARATOR

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

Drug: Buffered Lidocaine J-tip

Interventions

Buffered Lidocaine J-tip DRUG

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

Also known as: Normal Saline J-tip

Buffered lidocaine J-tip; Normal saline J-tip

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• fever in infants less than 3 months

You may not qualify if:

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

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (1)

Blake Bulloch/PhoenixChildren's Hospital

Phoenix, Arizona, 85018, United States

Location

Related 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.

  PMID: 22743744 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Angelique Ferayorni
• Organization: Phoenix Children's Hospital

aferayorni@phoenixchildrens.com

602-546-1910

Study Officials

• Blake Bulloch, MD

  Phoenix Childrens Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 20, 2010
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 23, 2018
• Results First Posted: June 14, 2011

Record last verified: 2018-09

Locations

US (1)