Clinical trial NCT00444756: Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Intravenous (IV) Catheterization in Children
Official title: Jet Injection of 1% Buffered Lidocaine Versus Topical ELA-Max for Anesthesia Prior to Peripheral Intravenous Catheterization in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: local anesthesia
analgesia
peripheral IV
Local anesthesia prior to peripheral IV insertion
Lead sponsor: Norton Healthcare
Sponsor class: OTHER
First posted: 2007-03-08
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 8-15 years requiring a PIV as part of their management in the emergency department.

Exclusion Criteria:

* Excluded from the study if they reported use of analgesic medication within 6 hours of enrollment,
* Had a Glasgow Coma Score \< 15,
* A baseline screening VAS pain score \> 20 mm, or
* A history of skin hypersensitivity or lidocaine allergy,
* Were incapable of self-reporting a pain score,
* Had a known neurological condition that alters pain perception,
* Had methemoglobinemia, or
* Did not speak or understand English.

Primary outcomes:
measure: VAS pain scores for the PIV insertion as judged by the patients and the blinded observer.
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
Study officials:
affiliation: Department of Pediatric Emergency Medicine, Department of Pediatrics, Kosair Children's Hospital, University of Louisville, Louisville, Kentucky
name: In K Kim, MD
role: STUDY_DIRECTOR
References:
citation: 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.