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Trial Outcomes & Findings for An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion (NCT NCT02162680)

NCT ID: NCT02162680

Last Updated: 2014-08-15

Results Overview

The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

99 participants

Primary outcome timeframe

at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute

Results posted on

2014-08-15

Participant Flow

99 subjects consented in the study. 1 subject withdrawn from study by PI, therefore 98 subjects completed study.

Participant milestones

Participant milestones
Measure
no Local Anesthetic
usual care practice of no local anesthetic administration
Lidocaine
1% lidocaine intradermal injection 1% lidocaine
Bacteriostatic Normal Saline (BNS)
bacteriostatic normal saline (BNS) injection bacteriostatic normal saline (BNS)
Overall Study
STARTED
33
33
32
Overall Study
COMPLETED
33
33
32
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
no Local Anesthetic
n=33 Participants
usual care practice of no local anesthetic administration
Lidocaine
n=33 Participants
1% lidocaine intradermal injection 1% lidocaine
Bacteriostatic Normal Saline (BNS)
n=32 Participants
bacteriostatic normal saline (BNS) injection bacteriostatic normal saline (BNS)
Total
n=98 Participants
Total of all reporting groups
Age, Customized
18 and older
33 participants
n=5 Participants
33 participants
n=7 Participants
32 participants
n=5 Participants
98 participants
n=4 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
23 Participants
n=7 Participants
16 Participants
n=5 Participants
55 Participants
n=4 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
10 Participants
n=7 Participants
16 Participants
n=5 Participants
43 Participants
n=4 Participants
Race/Ethnicity, Customized
White
23 participants
n=5 Participants
21 participants
n=7 Participants
15 participants
n=5 Participants
59 participants
n=4 Participants
Race/Ethnicity, Customized
African American
8 participants
n=5 Participants
7 participants
n=7 Participants
15 participants
n=5 Participants
30 participants
n=4 Participants
Race/Ethnicity, Customized
Other
2 participants
n=5 Participants
5 participants
n=7 Participants
2 participants
n=5 Participants
9 participants
n=4 Participants
Region of Enrollment
United States
33 participants
n=5 Participants
33 participants
n=7 Participants
32 participants
n=5 Participants
98 participants
n=4 Participants

PRIMARY outcome

Timeframe: at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute

The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.

Outcome measures

Outcome measures
Measure
no Local Anesthetic
n=33 Participants
usual care practice of no local anesthetic administration
Lidocaine
n=33 Participants
1% lidocaine intradermal injection 1% lidocaine
Bacteriostatic Normal Saline (BNS)
n=32 Participants
bacteriostatic normal saline (BNS) injection bacteriostatic normal saline (BNS)
Differences in Patients' Perceptions of Pain Between Treatment Methods
Pain pre injection
0.015 units on a scale
Standard Deviation 0.87
0 units on a scale
Standard Deviation 0
0 units on a scale
Standard Deviation 0
Differences in Patients' Perceptions of Pain Between Treatment Methods
Pain during catheter insertion
1.909 units on a scale
Standard Deviation 2.127
0.197 units on a scale
Standard Deviation 0.499
0.609 units on a scale
Standard Deviation 1.674
Differences in Patients' Perceptions of Pain Between Treatment Methods
Pain during study drug injection
NA units on a scale
Standard Deviation NA
Participants did not receive a study drug injection.
0.727 units on a scale
Standard Deviation 1.039
0.781 units on a scale
Standard Deviation 1.263

Adverse Events

no Local Anesthetic

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Lidocaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Bacteriostatic Normal Saline (BNS)

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

Julia Aucoin, DNS

Duke University Medical Center

Phone: 1 919 613 6406

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place