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Clinical Trials/NCT02162680
NCT02162680
Completed
Phase 4

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

Duke University0 sites99 target enrollmentMarch 2010

Overview

Phase
Phase 4
Intervention
1% lidocaine
Conditions
IV Insertion Pain
Sponsor
Duke University
Enrollment
99
Primary Endpoint
Differences in Patients' Perceptions of Pain Between Treatment Methods
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
July 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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;

Arms & Interventions

lidocaine

1% lidocaine intradermal injection

Intervention: 1% lidocaine

bacteriostatic normal saline (BNS)

bacteriostatic normal saline (BNS) injection

Intervention: bacteriostatic normal saline (BNS)

Outcomes

Primary Outcomes

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.

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