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

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ClinicalTrials.gov Identifier: NCT00924963
Recruitment Status : Terminated (Study ended due to lack of funding.)
First Posted : June 19, 2009
Last Update Posted : October 18, 2011
Information provided by (Responsible Party):

Study Description
Brief 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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Second attempt pain scores (if occurred) among the three groups and between their first and second VAS scores [ Time Frame: 30 minutes ]
  3. The success of venipuncture or PIVC insertion with all anesthetic techniques [ Time Frame: 30 minutes ]
  4. Variety of locations of successful venipuncture or PIVC insertion after jet injection use [ Time Frame: 30 minutes ]
  5. Measurement of complication rate after jet injection use [ Time Frame: 1 hour ]

Eligibility Criteria

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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924963

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
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

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00924963     History of Changes
Other Study ID Numbers: 2008-0922
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: June 2009

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

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action