Local Anesthetics for Pain Reduction Prior to IV Line Placement
Information source: Allina Health System
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Local Anesthesia for Peripheral Intravenous Catheterization
Intervention: Lidocaine (Drug); Buffered Lidocaine (Drug); Bacteriostatic Normal Saline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Allina Health System Official(s) and/or principal investigator(s): David M Gurda, PharmD, Principal Investigator, Affiliation: Allina Health Services
Summary
The purpose of this study is to compare the pain level felt by patients when receiving
placement of a peripheral intravenous catheter (IV line) following the administration of a
local anesthetic. The local anesthetics tested will be lidocaine, buffered lidocaine, and
bacteriostatic normal saline. Lidocaine is commonly used as a premedication for reducing
the pain upon insertion of peripheral IV lines. However, due to its acidic nature, the
lidocaine itself may cause pain upon administration. To help counter this discomfort,
pharmacies can "buffer" the lidocaine using sodium bicarbonate, which increases the pH to a
neutral value, resulting in less pain. Bacteriostatic normal saline has also been used for
local anesthesia with peripheral IV placement, particularly in patients with a lidocaine
allergy, as it contains benzyl alcohol which acts as a local anesthetic.
There are minimal reports from the literature that directly compare patient reported pain of
all three agents to one another, although studies do exist that have compared buffered
lidocaine versus lidocaine and buffered lidocaine versus bacteriostatic normal saline. To
address this comparison gap, the following research questions need to be asked: which
anesthetic agent is the superior premedication for reducing the amount of pain upon
administration of the local anesthetic itself and for the pain associated with the
peripheral insertion of the catheter? The hypothesis of the investigators is that there is
not a significant difference in the degree of pain scales between the anesthetic agents to
justify the pharmacoeconomic costs associated with compounding buffered lidocaine.
The primary outcome measured in this study will be the level of pain reported by the patient
upon administration of the local anesthetic and upon insertion of the peripheral intravenous
catheter. A secondary outcome includes a pharmacoeconomic analysis that will look
specifically at the cost-savings of using one agent over the other and will take into
account the daily time allocated to pharmacy technicians and pharmacists for compounding and
verifying buffered lidocaine.
Clinical Details
Official title: A Comparison of Lidocaine, Buffered Lidocaine, and Bacteriostatic Normal Saline for Local Anesthesia Prior to Peripheral Intravenous Catheterization
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Pain Score Following Anesthetic Administration
Secondary outcome: Economic analysis of cost of compounding buffered lidocaine versus cost of purchasing regular lidocaine and/or bacteriostatic normal saline
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females > 18 y. o.
- Ability to speak, read, an/or understand English
- Ability to communicate a level of pain via the specified pain scale
- A written order exists for an intravenous peripheral catheter insertion for the
patient
Exclusion Criteria:
- Lidocaine allergy
- Buffered lidocaine allergy
- Benzyl alcohol allergy
- Non-English speaking
- Non-responsive or unable to understand or report pain score (ex. intubated in the
ICU)
- Inability to place catheter
Locations and Contacts
United Hospital, part of Allina Health Services, Saint Paul, Minnesota 55102, United States
Additional Information
Starting date: January 2013
Last updated: August 9, 2013
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