Clinical trial NCT01759459
Conditions: Pain Local Anesthesia for Peripheral Intravenous Catheterization
Sponsor: Allina Health System
Start date: 2013-01-01; Completion date: 2013-06-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:

Arms: arm 1: 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm arm 2: 1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm

Buffered lidocaine is compounded by the following process:

2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine arm 3: Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm
Interventions: intervention 1: Lidocaine intervention 2: Buffered Lidocaine intervention 3: Bacteriostatic Normal Saline
Intervention descriptions: intervention 1: The medication will be administered immediately prior to receiving peripheral IV catheter placement intervention 2: The medication will be administered immediately prior to receiving peripheral IV catheter placement intervention 3: The medication will be administered immediately prior to receiving peripheral IV catheter placement

Protocol documents: