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An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162680
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 13, 2014
Results First Submitted Date  ICMJE June 26, 2014
Results First Posted Date  ICMJE August 15, 2014
Last Update Posted Date August 15, 2014
Study Start Date  ICMJE March 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Differences in Patients' Perceptions of Pain Between Treatment Methods [ Time Frame: at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute ]
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Differences in Patients' Perceptions of Pain Between Treatment Methods [ Time Frame: at pre, anesthetic injection, and cannulation, up to approximately 1 minute ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion
Official Title  ICMJE An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion
Brief Summary The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE IV Insertion Pain
Intervention  ICMJE
  • Drug: 1% lidocaine
  • Drug: bacteriostatic normal saline (BNS)
Study Arms  ICMJE
  • Active Comparator: lidocaine
    1% lidocaine intradermal injection
    Intervention: Drug: 1% lidocaine
  • Active Comparator: bacteriostatic normal saline (BNS)
    bacteriostatic normal saline (BNS) injection
    Intervention: Drug: bacteriostatic normal saline (BNS)
  • No Intervention: no local anesthetic
    usual care practice of no local anesthetic administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2014)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients (aged 18 or older)
  • admitted to a general medical or surgical unit at Durham Regional Hospital (DRH)
  • have a physician's order for an IV
  • are able to speak, read and understand English
  • referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization

Exclusion Criteria:

  • admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units;
  • history of a psychological disorder, as determined from the patient's chart;
  • history of peripheral neuropathy, as determined by patient's chart;
  • history of IV drug abuse, as determined from the patient's chart;
  • decreased sensation in the arm or hands, as reported in the chart or by the patient;
  • patient disorientation or confusion (i.e., unable to state person, place, time or unable to comprehend instructions for completing Visual Analog Scale);
  • a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart;
  • veins that cannot be palpated and are difficult to visualize by VAST nurses;
  • pregnancy;
  • an order for the emergency insertion of an IV by the patient's doctor or assigned nurse;
  • an IV insertion that requires the use of a catheter gauged 18 or larger
  • severe vision impairment, as determined by the patient's inability to read the Visual Analogue Scale
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162680
Other Study ID Numbers  ICMJE Pro00015861
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julia Aucoin, DNS, RN Duke University Health System
PRS Account Duke University
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP