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

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Duke University

Status and phase

Completed
Phase 4

Conditions

IV Insertion Pain

Treatments

Drug: bacteriostatic normal saline (BNS)
Drug: 1% lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02162680
Pro00015861

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

99 participants in 3 patient groups

lidocaine
Active Comparator group
Description:
1% lidocaine intradermal injection
Treatment:
Drug: 1% lidocaine
bacteriostatic normal saline (BNS)
Active Comparator group
Description:
bacteriostatic normal saline (BNS) injection
Treatment:
Drug: bacteriostatic normal saline (BNS)
no local anesthetic
No Intervention group
Description:
usual care practice of no local anesthetic administration

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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