Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
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|ClinicalTrials.gov Identifier: NCT01394250|
Recruitment Status : Completed
First Posted : July 14, 2011
Results First Posted : May 15, 2015
Last Update Posted : September 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain Anxiety||Device: Buzzy Drug: Topical Lidocaine 4% Cream||Phase 2|
Intravenous (IV) cannulation is a significant source of pediatric pain and distress. Accumulating evidence has demonstrated that pain from IV cannulation is a significant source of pediatric pain and distress with effects far more reaching than the presenting event. When describing worse pain experiences in hospitalized children, IV cannulation pain was found to be second only to pain related to the subject's underlying disease. Practitioners recognize the need to mitigate or decrease pediatric IV cannulation pain and distress in emergency department patients, yet often do not provide the relief measures that are available. The use of topical lidocaine cream has some barriers, including the need to predict the need for the IV, the 30 minute administration time, difficulty in applying and maintaining the cream, the need for a physician's order and nursing to override in the Pyxis machine in order to obtain the medication in a timely manner.
Buzzy® provides a potential alternative to treating pediatric IV cannulation pain in the emergency department (ED), as cold and vibration are quick-acting options for pain relief. If Buzzy® is demonstrated to be as effective or more effective for reducing the pain of IV cannulation it would be an inexpensive and rapid way to provide pain control in accordance to the American Academy of Pediatrics (AAP) and American Pain Society recommendations. The device's actions are based on the Gate Control Theory, whereby cold and vibratory stimulation stimulate large fiber and inhibitory neurons to interrupt nociception. The benefits of Buzzy® include a low cost of $34.99 per reusable device, which could also provide a significant cost savings over the use of single tubes of topical lidocaine cream at a cost of $4.62-12.00 per tube with one or more tubes needed for each patient. Buzzy® does not require a medical order, but must be cleaned according to institution standards and is supplied with either a reusable cold pack or single use cold packs as desired. The commonly voiced concern related to the application of cold causing vasoconstriction has not been borne out in prior studies of Buzzy®.
Self-report of pain is the gold standard in evaluating pediatric pain. For this study we will use the Faces Pain Scale-Revised (FPS-R) for rating self-reported pain in children ages 4-18 years. The FPS-R has been validated and frequently used in pediatric pain studies. The FPS-R consists of 6 cartoon faces that range from a neutral expression ("no pain") to one of very much pain. Using the same faces, children will be asked how much the procedure "hurt" from "no hurt" to "very much hurt". Self-reporting of pain is the primary source of data and a secondary measure of data will be an observational pain scale, the face, legs, activity, cry, consolability (FLACC) scale. Because anxiety has proven to affect pain ratings, we will also evaluate anxiety using "Child Rating of Anxiety Scale", a visual semantic scale in the form of a thermometer for rating anxiety.
All subjects in this study will develop and implement a coping plan with a Child Life Specialist, including preparation, distraction, and deep breathing. This is standard of care in our ED and applied whenever possible for IV placement procedures. Child Life Specialists prepare subjects and families prior to medical procedures to decrease anxiety and increase understanding. Psychological preparation is aimed to increase a subject and family's control over a situation or procedure. While decreasing anxiety and increasing control, the child can move past the event with a sense of mastery and a low level of distress. Preparation close to the event is important for younger subjects, whereas preparation for older subjects is more beneficial when initiated earlier. The effectiveness of distraction in needle related procedures is well documented in the literature. Distraction involves a supportive care giver (if present) as well as a Certified Child Life Specialist; all attempts are made to focus of child away from the pain of the procedure and when possible the child is permitted to hold the objects and manipulate them prior to the procedure to enhance the utilization of a coping plan.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Testing the Efficacy of a Vibrating, Cold Device for Pediatric IV Cannulation Pain Relief in the Emergency Department|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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.
Cold, Vibrational Device
Active Comparator: Topical Lidocaine 4% Cream
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.
Drug: Topical Lidocaine 4% Cream
Applied to anticipated IV site at least 30 minutes prior to cannulation.
Other Name: AneCream™; Anestacon®; Dalcaine®; L-M-X™4; Xylocaine®
- Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation [ Time Frame: Baseline and 30 minutes ]The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of "no pain" (0) to "very much pain" (10).
- Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups [ Time Frame: Up to 5 minutes after IV Cannulation ]The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The FLACC score was completed immediately after IV cannulation by a member of the clinical care team who was not part of the study. During initial trial design, the goal was to collect FLACC score pre and post cannulation; however, it was decided prior to enrollment that FLACC score would not be collected pre cannulation, only post.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394250
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Joel Fein, MD, MPH||Children's Hospital of Philadelphia|
|Study Director:||Debra Potts, MSN, RN||Children's Hospital of Philadelphia|