J-Tip® Jet Injection of 1% Buffered Lidocaine or Saline Versus 4% Lidocaine Cream Before Venipuncture or IV Insertion

This study has been terminated.
(Study ended due to lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00924963
First received: June 18, 2009
Last updated: October 17, 2011
Last verified: June 2009
  Purpose

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.


Condition Intervention
Pain
Device: J-Tip jet injector
Device: Jet injection saline
Drug: lidocaine cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Jet injection of 1% buffered lidocaine to jet injection of saline to assess and measure a potential placebo effect not measured in prior studies [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • The success of venipuncture or PIVC insertion with all anesthetic techniques [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Variety of locations of successful venipuncture or PIVC insertion after jet injection use [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Measurement of complication rate after jet injection use [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 132
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Jet injection lidocaine
J-Tip jet injection of 1% buffered lidocaine
Device: J-Tip jet injector
0.2ml 1%buffered lidocaine delivered by jet injector
Placebo Comparator: Jet injection saline
J-Tip jet injection of sterile saline
Device: Jet injection saline
0.2ml saline delivered via J-Tip jet injection
Active Comparator: Lidocaine cream
Lidocaine 4%cream applied for 30 minutes prior to IV insertion or venipuncture
Drug: lidocaine cream
4% lidocaine cream applied for 30 minutes to the skin

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924963

Locations
United States, Ohio
Cincinnati Children's Hospital Liberty Township Emergency Department
Liberty Township, Ohio, United States, 45044
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Stephanie L Spanos, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Srikant Iyer, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00924963     History of Changes
Other Study ID Numbers: 2008-0922
Study First Received: June 18, 2009
Last Updated: October 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Pain of venipuncture or IV insertion

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014