Needle-Free Jet Injection of Lidocaine During Lumbar Puncture
NCT ID: NCT01224431
Last Updated: 2018-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2009-06-30
2010-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Buffered lidocaine J-tip
Needleless injection of buffered lidocaine prior to lumbar puncture versus placebo (Normal saline)
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
Normal saline J-tip
Needleless injection of normal saline (placebo) prior to lumbar puncture versus use of buffered lidocaine
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
90 Days
ALL
No
Sponsors
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Phoenix Children's Hospital
OTHER
Responsible Party
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Blake Bulloch
MD
Principal Investigators
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Blake Bulloch, MD
Role: STUDY_DIRECTOR
Phoenix Childrens Hospital
Locations
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Blake Bulloch/PhoenixChildren's Hospital
Phoenix, Arizona, United States
Countries
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References
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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.
Other Identifiers
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09-014
Identifier Type: -
Identifier Source: org_study_id
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