J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion
Information source: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: J-Tip jet injector (Device); Jet injection saline (Device); lidocaine cream (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Children's Hospital Medical Center, Cincinnati Official(s) and/or principal investigator(s): Stephanie L Spanos, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati Srikant Iyer, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
Summary
To measure and compare pain associated with venipuncture and peripheral intravenous catheter
insertion among pediatric emergency department patients randomized to treatment with one of
three different pain-reduction strategies: J-Tip® jet injection of 1% buffered lidocaine,
J-Tip® jet injection of sterile saline, or application of 4% lidocaine topical cream. The
investigators hypothesize that J-Tip® jet injection of 1% buffered lidocaine will provide
superior local anesthesia compared to saline or lidocaine cream.
Clinical Details
Official title: Comparison of J-Tip® Jet Injection of 1% Buffered Lidocaine, 4% Lidocaine Topical Cream, and J-Tip® Jet Injection of Placebo Prior to Venipuncture and Peripheral Intravenous Catheter Insertion in a Pediatric Emergency Department
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Jet injection of 1% buffered lidocaine to 4% lidocaine topical cream to measure the effectiveness of jet injection of lidocaine as a local anesthetic prior to venipuncture and PIVC insertion
Secondary outcome: Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studiesSecond attempt pain scores (if occurred) among the three groups and between their first and second VAS scores The success of venipuncture or PIVC insertion with all anesthetic techniques Variety of locations of successful venipuncture or PIVC insertion after jet injection use Measurement of complication rate after jet injection use
Eligibility
Minimum age: 7 Years.
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children aged seven to twenty-one years old requiring venipuncture or PIVC insertion
as part of their emergency department care are eligible for the study.
Exclusion Criteria:
- Lidocaine allergy,
- TegadermTM allergy,
- Glasgow Coma Score (GCS) less than 15,
- Pain at the proposed site for the procedure,
- Requirement of a PIVC or venipuncture immediately due to illness acuity,
- Inability to complete a self-reported pain scale (VAS, visual analogue scale),
- Patients who do not speak and understand English, OR
- Previous enrollment in the study.
Locations and Contacts
Cincinnati Children's Hospital Liberty Township Emergency Department, Liberty Township, Ohio 45044, United States
Additional Information
Starting date: June 2009
Last updated: October 17, 2011
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