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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm |
|
| Buffered Lidocaine | Experimental | 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 |
|
| Bacteriostatic Normal Saline | Experimental | Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | The medication will be administered immediately prior to receiving peripheral IV catheter placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score Following Anesthetic Administration | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score Following Peripheral Catheter Insertion | 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. | Baseline and day 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Gurda, PharmD | Allina Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Hospital, part of Allina Health Services | Saint Paul | Minnesota | 55102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22403968 | Result | Beck RM, Zbierajewski FJ, Barber MK, Engoren M, Thomas R. A comparison of the pain perceived during intravenous catheter insertion after injection with various local anesthetics. AANA J. 2011 Aug;79(4 Suppl):S58-61. | |
| 15085035 | Result | Brown D. Local anesthesia for vein cannulation: a comparison of two solutions. J Infus Nurs. 2004 Mar-Apr;27(2):85-8. doi: 10.1097/00129804-200403000-00004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Buffered Lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score Following Anesthetic Administration | 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. | Posted | Mean | Full Range | units on a scale | Day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Gurda | Allina Health | 612-863-6566 | david.gurda@allina.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Buffered Lidocaine | Drug | The medication will be administered immediately prior to receiving peripheral IV catheter placement |
|
|
| Bacteriostatic Normal Saline | Drug | The medication will be administered immediately prior to receiving peripheral IV catheter placement |
|
|
| 3 months |
| 17276670 | Result | Carvalho B, Fuller A, Brummel C, Cohen SE. Local infiltration of epinephrine-containing lidocaine with bicarbonate reduces superficial bleeding and pain during labor epidural catheter insertion: a randomized trial. Int J Obstet Anesth. 2007 Apr;16(2):116-21. doi: 10.1016/j.ijoa.2006.09.006. Epub 2007 Feb 5. |
| 8894861 | Result | Cornelius P, Kendall J, Meek S, Rajan R. Alkalinisation of lignocaine to reduce the pain of digital nerve blockade. J Accid Emerg Med. 1996 Sep;13(5):339-40. doi: 10.1136/emj.13.5.339. |
| 21270583 | Result | Burke SD, Vercler SJ, Bye RO, Desmond PC, Rees YW. Local anesthesia before IV catheterization. Am J Nurs. 2011 Feb;111(2):40-5; quiz 46-7. doi: 10.1097/01.NAJ.0000394291.40330.3c. |
| 10195475 | Result | Fatovich DM, Jacobs IG. A randomized controlled trial of buffered lidocaine for local anesthetic infiltration in children and adults with simple lacerations. J Emerg Med. 1999 Mar-Apr;17(2):223-8. doi: 10.1016/s0736-4679(98)00157-7. |
| 22382793 | Result | Ganter-Ritz V, Speroni KG, Atherton M. A randomized double-blind study comparing intradermal anesthetic tolerability, efficacy, and cost-effectiveness of lidocaine, buffered lidocaine, and bacteriostatic normal saline for peripheral intravenous insertion. J Infus Nurs. 2012 Mar-Apr;35(2):93-9. doi: 10.1097/NAN.0b013e31824241cc. |
| 19217695 | Result | McNaughton C, Zhou C, Robert L, Storrow A, Kennedy R. A randomized, crossover comparison of injected buffered lidocaine, lidocaine cream, and no analgesia for peripheral intravenous cannula insertion. Ann Emerg Med. 2009 Aug;54(2):214-20. doi: 10.1016/j.annemergmed.2008.12.025. Epub 2009 Feb 13. |
| 14569436 | Result | Nakayama M, Munemura Y, Kanaya N, Tsuchida H, Namiki A. Efficacy of alkalinized lidocaine for reducing pain on intravenous and epidural catheterization. J Anesth. 2001;15(4):201-3. doi: 10.1007/s005400170003. |
| 16935736 | Result | Windle PE, Kwan ML, Warwick H, Sibayan A, Espiritu C, Vergara J. Comparison of bacteriostatic normal saline and lidocaine used as intradermal anesthesia for the placement of intravenous lines. J Perianesth Nurs. 2006 Aug;21(4):251-8. doi: 10.1016/j.jopan.2006.05.007. |
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline pain scores | The outcome measured 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. Baseline pain scores were also recorded using this same scale | Mean | Full Range | units on a scale |
|
| OG002 | 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 |
|
|
| Secondary | Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline | 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. | 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. | Posted | Number | Dollars | 3 months | Medication vials | Medication vials |
|
|
|
| Other Pre-specified | Pain Score Following Peripheral Catheter Insertion | 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. | Posted | Mean | Full Range | units on a scale | Baseline and day 1 |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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 | 0 | 50 | 0 | 50 | 0 | 50 |
| EG002 | 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 | 0 | 50 | 0 | 50 | 0 | 50 |
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| Aniline Compounds |
| D000588 | Amines |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Average pain score following IV inserti |
|