Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain |
Drug: jtip needleless lidocaine injection |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Needle-Free Jet Injection of Lidocaine for Local Anesthesia During Lumbar Puncture: A Randomized Controlled Trial |
- Pain, Measured as Units on a Scale [ Time Frame: on average the first hour in emergency department at 4 time points during entire lumbar puncture procedure. ] [ Designated as safety issue: No ]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
- Length of Cry [ Time Frame: On average the first hour in the emergency department; from needle stick to end of lumbar puncture ] [ Designated as safety issue: No ]cry video recorded and measured after needle stick until pt stopped crying
- Heart Rate [ Time Frame: On average the first hour in the emergency department, at 4 time points during lumbar puncture procedure. ] [ Designated as safety issue: No ]patient on Cardiopulmonary monitoring
| Enrollment: | 60 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: needleless injection of buffered lidocaine
needleless injection of buffered lidocaine prior to lumbar puncture
|
Drug: jtip needleless lidocaine injection
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
Other Name: jtip is the brand name for 1% buffered lidocaine needleless injection
|
|
Placebo Comparator: normal saline via needleless injection
needleless injection of normal saline prior to lumbar puncture
|
Drug: jtip needleless lidocaine injection
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
Other Name: jtip is the brand name for 1% buffered lidocaine needleless injection
|
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.
Eligibility| Ages Eligible for Study: | up to 90 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Angelique Ferayorni/ Blake Bulloch, Phoenix Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01224431 History of Changes |
| Other Study ID Numbers: | 09-014 |
| Study First Received: | September 30, 2010 |
| Results First Received: | April 5, 2011 |
| Last Updated: | June 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Phoenix Children's Hospital:
|
pain lidocaine lumbar puncture j-tip |
Additional relevant MeSH terms:
|
Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013