Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
Pain, Anxiety
About this trial
This is an interventional treatment trial for Pain focused on measuring Pain, Anxiety, IV Cannulation, Topical Lidocaine, Buzzy, Face, Legs, Activity, Crying, Consolability (FLACC) scale, Faces Pain Scale Revised (FPS-R), Child Rating of Anxiety Scale
Eligibility Criteria
Inclusion Criteria:
- Subject is aged 4 to 18 years of age
- Subjects will be having a peripheral IV line placed at the discretion of the treating physician for usual care of presenting complaints.
- Physician in charge of the subject is willing to wait the 30 minutes needed for the study preparation
- Subject/caregiver understands English
- Parent or legal guardian has signed Institutional Review Board (IRB) approved informed consent and subject (if age 7 years or older) has given assent
Exclusion Criteria:
- Subject is critically ill with a triage category of 1
- Subject has a condition that precludes the use of the self-report pain scale
- Subject has an abrasion, infection or break in skin in the area where Buzzy® would be placed
- Nerve damage is present in the extremity for planned IV placement
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Buzzy
Topical Lidocaine 4% Cream
If randomized to Buzzy®, the nurse will demonstrate the cold pack and the device just prior to the IV cannulation procedure. The device will be applied with a Velcro strap 5 centimeters proximal to the site of IV cannulation; it will remain in place until the IV cannula is inserted and secured. All nurses that work during the study hours will be trained on the device prior to beginning the study. Training includes direct one-one training with the device including return demonstration.
If randomized to topical lidocaine cream, subjects will have the cream placed on two or more potential IV sites as soon as possible after the consent procedure is complete. These subjects will undergo IV placement no less than 30 minutes after the cream is applied.