Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT01759459
Status:
COMPLETED
Last Update Posted:
2022-07-15
First Post:
2012-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Local Anesthetics for Pain Reduction Prior to IV Line Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.gurda@allina.com', 'phone': '612-863-6566', 'title': 'David Gurda', 'organization': 'Allina Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine', 'description': '1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nLidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Buffered Lidocaine', 'description': '1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBuffered lidocaine is compounded by the following process:\n\n2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine\n\nBuffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bacteriostatic Normal Saline', 'description': 'Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Score Following Anesthetic Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': '1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nLidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'OG001', 'title': 'Buffered Lidocaine', 'description': '1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBuffered lidocaine is compounded by the following process:\n\n2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine\n\nBuffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'OG002', 'title': 'Bacteriostatic Normal Saline', 'description': 'Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.64', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.05', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}, {'units': 'Medication vials', 'counts': [{'value': '9676', 'groupId': 'OG000'}, {'value': '9676', 'groupId': 'OG001'}, {'value': '9676', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Buffered Lidocaine Cost', 'description': 'An analysis adding up the costs of drug purchasing, technician compounding time, and pharmacist verifying time. Based on salaries during this period, technician costs = $0.03/minute and pharmacist costs = $1.00/minute.'}, {'id': 'OG001', 'title': 'Lidocaine Cost', 'description': 'An analysis adding up the costs of drug purchasing alone.'}, {'id': 'OG002', 'title': 'Bacteriostatic Normal Saline Cost', 'description': 'An analysis adding up the costs of drug purchasing alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '13400', 'groupId': 'OG000'}, {'value': '9100', 'groupId': 'OG001'}, {'value': '4840', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': '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.', 'unitOfMeasure': 'Dollars', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Medication vials', 'denomUnitsSelected': 'Medication vials', 'populationDescription': '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.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pain Score Following Peripheral Catheter Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': '1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nLidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'OG001', 'title': 'Buffered Lidocaine', 'description': '1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBuffered lidocaine is compounded by the following process:\n\n2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine\n\nBuffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'OG002', 'title': 'Bacteriostatic Normal Saline', 'description': 'Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}], 'classes': [{'title': 'Average pain score following medication injection', 'categories': [{'measurements': [{'value': '2.58', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '2.10', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}, {'title': 'Average pain score following IV inserti', 'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '1.81', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.05', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and day 1', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine', 'description': '1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nLidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'FG001', 'title': 'Buffered Lidocaine', 'description': '1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBuffered lidocaine is compounded by the following process:\n\n2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine\n\nBuffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'FG002', 'title': 'Bacteriostatic Normal Saline', 'description': 'Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '150', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine', 'description': '1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nLidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'BG001', 'title': 'Buffered Lidocaine', 'description': '1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBuffered lidocaine is compounded by the following process:\n\n2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine\n\nBuffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'BG002', 'title': 'Bacteriostatic Normal Saline', 'description': 'Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '75'}, {'value': '56.6', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '75'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '75'}, {'value': '57.5', 'groupId': 'BG003', 'lowerLimit': '20', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline pain scores', 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0.03', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0.15', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0.09', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'description': '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', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2012-12-27', 'resultsFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2012-12-31', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-07-13', 'studyFirstPostDateStruct': {'date': '2013-01-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain Score Following Peripheral Catheter Insertion', 'timeFrame': 'Baseline and day 1', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Pain Score Following Anesthetic Administration', 'timeFrame': 'Day 1', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline', 'timeFrame': '3 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain', 'Local Anesthesia for Peripheral Intravenous Catheterization']}, 'referencesModule': {'references': [{'pmid': '22403968', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '15085035', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '17276670', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '8894861', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '21270583', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '10195475', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22382793', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '19217695', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '14569436', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '16935736', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThere 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females \\> 18 y.o.\n* Ability to speak, read, an/or understand English\n* Ability to communicate a level of pain via the specified pain scale\n* A written order exists for an intravenous peripheral catheter insertion for the patient\n\nExclusion Criteria:\n\n* Lidocaine allergy\n* Buffered lidocaine allergy\n* Benzyl alcohol allergy\n* Non-English speaking\n* Non-responsive or unable to understand or report pain score (ex. intubated in the ICU)\n* Inability to place catheter'}, 'identificationModule': {'nctId': 'NCT01759459', 'briefTitle': 'Local Anesthetics for Pain Reduction Prior to IV Line Placement', 'organization': {'class': 'OTHER', 'fullName': 'Allina Health System'}, 'officialTitle': 'A Comparison of Lidocaine, Buffered Lidocaine, and Bacteriostatic Normal Saline for Local Anesthesia Prior to Peripheral Intravenous Catheterization', 'orgStudyIdInfo': {'id': '3867-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': '1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Buffered Lidocaine', 'description': '1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm\n\nBuffered lidocaine is compounded by the following process:\n\n2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine', 'interventionNames': ['Drug: Buffered Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Bacteriostatic Normal Saline', 'description': 'Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm', 'interventionNames': ['Drug: Bacteriostatic Normal Saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Hospira brand 1% Lidocaine in 20 mL vial'], 'description': 'The medication will be administered immediately prior to receiving peripheral IV catheter placement', 'armGroupLabels': ['Lidocaine']}, {'name': 'Buffered Lidocaine', 'type': 'DRUG', 'otherNames': ['Hospira brand 1% Lidocaine in 20 mL vial', 'Hospira brand 8.4% sodium bicarbonate in 50 mL vial'], 'description': 'The medication will be administered immediately prior to receiving peripheral IV catheter placement', 'armGroupLabels': ['Buffered Lidocaine']}, {'name': 'Bacteriostatic Normal Saline', 'type': 'DRUG', 'otherNames': ['Hospira brand Bacteriostatic Normal Saline in 10 mL vial'], 'description': 'The medication will be administered immediately prior to receiving peripheral IV catheter placement', 'armGroupLabels': ['Bacteriostatic Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'United Hospital, part of Allina Health Services', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'David M Gurda, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allina Health Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allina Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator/PharmD', 'investigatorFullName': 'David Gurda', 'investigatorAffiliation': 'Allina Health System'}}}}