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This trial is a comparison of the anesthetic effectiveness of J-Tip needle-free jet injection of 1% buffered lidocaine to the anesthetic effectiveness of topical 4% ELA-Max for peripheral intravenous catheter (PIV) insertion. The researchers hypothesize that the jet injection of lidocaine will provide superior anesthesia to the ELA-Max prior to PIV insertion.
A prospective, block-randomized, controlled trial comparing J-Tip jet injection of 1% buffered lidocaine to a 30-minute application of 4% ELA-Max for topical anesthesia in children 8-15 years old presenting to a tertiary care pediatric emergency department for PIV insertion. All subjects recorded self-reported Visual Analogue Scale (VAS) scores for pain at time of enrollment and pain of PIV insertion. Jet injection subjects also recorded pain of jet injection. Subjects were videotaped during jet injection and PIV insertion. Videotapes were reviewed by a single blinded reviewer for observer-reported VAS pain scores for jet injection and PIV insertion.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| J-tip jet injection of 1% buffered lidocaine | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| VAS pain scores for the PIV insertion as judged by the patients and the blinded observer. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measures included patient and blinded observer VAS scores for pain of jet injection, patient and blinded observer scores for anxiety of PIV insertion, nursing satisfaction of placing the PIV with jet injection or ELA-Maxâ, nursing diffi |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In K Kim, MD | Department of Pediatric Emergency Medicine, Department of Pediatrics, Kosair Children's Hospital, University of Louisville, Louisville, Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18645542 | Derived | Spanos S, Booth R, Koenig H, Sikes K, Gracely E, Kim IK. Jet Injection of 1% buffered lidocaine versus topical ELA-Max for anesthesia before peripheral intravenous catheterization in children: a randomized controlled trial. Pediatr Emerg Care. 2008 Aug;24(8):511-5. doi: 10.1097/PEC.0b013e31816a8d5b. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |