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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014