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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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