NCT Number: NCT02162680
An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
bacteriostatic normal saline (BNS)
DrugPrimary 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.
Sponsors and collaborators
Lead sponsor
Duke University
Other
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jun 13, 2014
- Registry last updated
- Aug 15, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.