Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department
1 other identifier
interventional
150
1 country
1
Brief Summary
The purpose of this study is to explore to what degree, if any, Jet lidocaine will reduce or alleviate pain, as compared to Jet normal saline, in children undergoing needle insertion in the Pediatric Emergency Department (PED). If effective, Jet lidocaine would afford a novel rapidly acting local anesthesic for children in the PED.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Mar 2007
Typical duration for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFebruary 6, 2009
February 1, 2009
8 months
May 19, 2008
February 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain, the primary outcome, will be assessed using the Color Analogue pain Scale before and after needle insertion in each group and compared for a clinically significant difference.
Primary outcome was measured at time of initial needlestick in ED
Secondary Outcomes (1)
Provider and patient satisfaction.
Secondary outcome was measured at time of initial needlestick in ED.
Study Arms (2)
1
EXPERIMENTALJet lidocaine
2
PLACEBO COMPARATORJet saline
Interventions
Eligibility Criteria
You may qualify if:
- Age 5 - 18 years
- Evaluation and treatment requiring needle insertion in \<60 minutes (Patient is not a candidate for EMLA cream)
- Parent or patient consent, and child assent
You may not qualify if:
- Age \<5 years or \>18 years
- Children eligible for or receiving EMLA cream
- Significant blunt or penetrating trauma requiring rapid evaluation/resuscitation (GCS\<15)
- Unstable shock
- Altered sensorium or intoxication
- History of allergy to Lidocaine
- Neurologic deficit involving a lack of sensation in area of insertion
- Developmental delay so as not to understand pain scale
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bellevue Hospital
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Mojica
NYU/Bellevue
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
March 1, 2007
Primary Completion
November 1, 2007
Study Completion
July 1, 2008
Last Updated
February 6, 2009
Record last verified: 2009-02