Trial Outcomes & Findings for Local Anesthetics for Pain Reduction Prior to IV Line Placement (NCT NCT01759459)

Results Overview

The primary outcome measured in this study will be the level of pain reported, on a scale of 0 to 10, 0 being no pain at all and 10 being the worst pain ever felt, by the patient upon administration of the local anesthetic and upon insertion of the peripheral intravenous catheter.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

Day 1

Results posted on

2022-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Buffered Lidocaine 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 Buffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Bacteriostatic Normal Saline Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm Bacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement
Overall Study STARTED	50	50	50
Overall Study COMPLETED	50	50	50
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Local Anesthetics for Pain Reduction Prior to IV Line Placement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=50 Participants 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Buffered Lidocaine n=50 Participants 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 Buffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Bacteriostatic Normal Saline n=50 Participants Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm Bacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Total n=150 Participants Total of all reporting groups
Age, Continuous	58.3 years n=5 Participants	56.6 years n=7 Participants	56 years n=5 Participants	57.5 years n=4 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	25 Participants n=7 Participants	29 Participants n=5 Participants	78 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	21 Participants n=5 Participants	72 Participants n=4 Participants
Baseline pain scores	0.09 units on a scale n=5 Participants	0.03 units on a scale n=7 Participants	0.15 units on a scale n=5 Participants	0.09 units on a scale n=4 Participants

PRIMARY outcome

Timeframe: Day 1

The primary outcome measured in this study will be the level of pain reported, on a scale of 0 to 10, 0 being no pain at all and 10 being the worst pain ever felt, by the patient upon administration of the local anesthetic and upon insertion of the peripheral intravenous catheter.

Outcome measures

Outcome measures
Measure	Lidocaine n=50 Participants 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Buffered Lidocaine n=50 Participants 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 Buffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Bacteriostatic Normal Saline n=50 Participants Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm Bacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement
Pain Score Following Anesthetic Administration	2.81 units on a scale Interval 0.0 to 10.0	1.64 units on a scale Interval 0.0 to 10.0	2.05 units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 3 months

Population: An analysis adding up the costs of drug purchasing, technician compounding time, and pharmacist verifying time, within a quarter of a year. Buffered lidocaine required both drug purchasing and compounding time, where the lidocaine and bacteriostatic normal saline required drug purchasing alone and labor costs were not taken into account.

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. The outcome data was measured and reported in a single value dollar amount per group, tallied over a 3 month period. The dollar amounts were estimated by adding up the costs of drug purchasing, technician compounding time, and pharmacist verifying time. Buffered lidocaine required both drug purchasing and compounding time, where the lidocaine and bacteriostatic normal saline required drug purchasing alone and labor costs were not taken into account.

Outcome measures

Outcome measures
Measure	Lidocaine n=50 Participants 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Buffered Lidocaine n=50 Participants 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 Buffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Bacteriostatic Normal Saline n=9676 Medication vials Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm Bacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement
Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline	13400 Dollars	9100 Dollars	4840 Dollars

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and day 1

The primary outcome measured in this study will be the level of pain reported, on a scale of 0 to 10, 0 being no pain at all and 10 being the worst pain ever felt, by the patient upon administration of the local anesthetic and upon insertion of the peripheral intravenous catheter.

Outcome measures

Outcome measures
Measure	Lidocaine n=50 Participants 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Buffered Lidocaine n=50 Participants 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 Buffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement	Bacteriostatic Normal Saline n=50 Participants Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm Bacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement
Pain Score Following Peripheral Catheter Insertion Average pain score following medication injection	2.58 units on a scale Interval 0.0 to 10.0	1.6 units on a scale Interval 0.0 to 10.0	2.10 units on a scale Interval 0.0 to 10.0
Pain Score Following Peripheral Catheter Insertion Average pain score following IV inserti	1.81 units on a scale Interval 0.0 to 10.0	1.81 units on a scale Interval 0.0 to 10.0	3.05 units on a scale Interval 0.0 to 10.0

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buffered Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bacteriostatic Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Gurda

Allina Health

Phone: 612-863-6566

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place