A Phase 4 interventional study of Lidocaine 2% Injectable Solution and Buzzy in Pain, Acute and Patient Satisfaction, sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc.. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by Steward St. Elizabeth's Medical Center of Boston, Inc. · Phase 4, Interventional, and Prevention
IV placement is necessary for surgical procedures. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable.
Currently, some medical providers administer the IV without any pain-relieving techniques. Some medical providers inject a numbing medication underneath the skin prior to the IV placement. This requires an additional needle stick. Some medical providers place a device called Buzzy® on a patient's arm prior to the IV placement. The Buzzy® device is the combination of an ice pack and a vibrator in the shape of a bumble bee. Literature shows that the Buzzy® device makes IV placement more comfortable for children, but there is minimal data in regard to whether it is helpful for adult patients.
The investigators are conducting this study to compare the effectiveness of the Buzzy® device with that of the injection of numbing medication underneath the skin for IV placement in adults. This device has been FDA approved for use.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
Browse Acute Pain studies →Steward St. Elizabeth's Medical Center of Boston, Inc. is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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Drug: Lidocaine 2% Injectable Solution
Device: Buzzy
An elastic band will be placed around the subject's arm, and the elastic band will be removed once the IV is inserted. After the elastic band is placed on the subject's arm, the arm will be cleaned, and then a small skin wheel will be created with the lidocaine that will be injected very close to where the IV will be placed. The IV will be placed within about a minute from the time when the lidocaine was injected.
The Buzzy vibrating ice pack will be placed on the subject's arm with an elastic band around it, and it will remain there as the arm is cleaned and prepped and the IV inserted. The Buzzy device will be removed once the IV is inserted.
Pain with IV Cannulation based on the Visual Analog Scale
How much pain do adult patients experience with peripheral IV cannulation when Buzzy® device is used versus when intradermal lidocaine 2% is used? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Time frame: 5-20 minutes
Satisfaction with IV cannulation based on the Numerical Rating Scale
How much satisfaction do adult patients experience with peripheral IV cannulation when Buzzy® device is used versus when intradermal lidocaine 2% is used? The Numerical Rating Scale is used for linear measurement of satisfaction, where the minimum number is 1 (very dissatisfied) and the maximum number is 5 (very satisfied).
Time frame: 5-20 minutes
Number of IV cannulation attempts
How does first attempt during peripheral intravenous cannulation in adult patients compare when Buzzy® device is used versus when intradermal lidocaine 2% is used?
Time frame: 5-20 minutes
Pain related to IV size based on the Visual Analog Scale
Does size of the peripheral intravenous catheter affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Time frame: 5-20 minutes
Pain related to IV location based on the Visual Analog Scale
Does location of the peripheral intravenous catheter placement affect the pain that adult patients experience with peripheral IV cannulation? The Visual Analog Scale is used for linear measurement of pain, where the minimum number is 0 (no pain) and the maximum number is 10 (unimaginable pain).
Time frame: 5-20 minutes
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Steward St. Elizabeth's Medical Center of Boston, Inc.