Trial Outcomes & Findings for Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage (NCT NCT01673061)
NCT ID: NCT01673061
Last Updated: 2020-03-19
Results Overview
Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.
TERMINATED
PHASE4
21 participants
Once, on Day 1, at time of anesthetic administration
2020-03-19
Participant Flow
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Participant milestones
| Measure |
Lidocaine
Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.
Lidocaine: See associated Arm Description
|
Vapocoolant
Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.
Vapocoolant: See associated Arm Description
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Once, on Day 1, at time of anesthetic administrationPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Once, on Day 1, at time of incision and drainagePopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Once, on Day 1Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Once, on Day 1Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at after all aspects of incision and drainage are complete, on Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Once, on Day 1Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Willingness of the subject to use their assigned method of anesthesia again if they were to require the same procedure in the future. Measured once on Day 1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured continuosly from consent to discharge, on Day 1.Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Any unexpected events that would occur during study period, including adverse events, on Day 1.
Outcome measures
Outcome data not reported
Adverse Events
Lidocaine
Vapocoolant
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kamran Mohiuddin, Director Clinical Research Emergency Medicine
Albert Einstein Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place