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Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
This study is currently recruiting participants.
Verified May 2012 by Children's Hospital of Philadelphia

First Received on June 3, 2011.   Last Updated on May 16, 2012   History of Changes
Sponsor: Children's Hospital of Philadelphia
Information provided by (Responsible Party): Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01394250
  Purpose

The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable device that provides cold and vibration, in reducing the pain associated with intravenous (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical lidocaine cream in reducing the pain associated with IV cannulation.


Condition Intervention Phase
Pain
Anxiety
Device: Buzzy
Drug: Topical Lidocaine 4% Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing the Efficacy of a Vibrating, Cold Device for Pediatric IV Cannulation Pain Relief in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Difference in the FPR-S pain score after IV cannulation between Buzzy and topical lidocaine. [ Time Frame: approximately 5 minutes before and immediately (within 1 minute) following IV cannulation ] [ Designated as safety issue: No ]
    Pain will be assessed pre and post IV cannulation using the Faces Pain Scale Revised (FPS-R). The FPS-R consists of 6 cartoon faces that range from a neutral expression ("no pain") to one of very much pain. The FPS-R has been validated and frequently used in pediatric pain studies. Using the same faces, children will be asked how much the procedure "hurt" from "no hurt" to "very much hurt."


Secondary Outcome Measures:
  • Difference in the FLACC scale and Self-reported anxiety scale between study intervention groups [ Time Frame: approximately 5 minutes before and immediately (within 1 minute) following IV cannulation ] [ Designated as safety issue: No ]

    A member of the study team will code the FLACC Scale for the subject's first IV cannulation attempt only in the following intervals: placement of tourniquet, needle stick, and placement of dressing or band aid.

    Self-reported anxiety, prior to IV cannulation, will be assessed using the Child's Rating of Anxiety, a visual semantic differential scale in the form of a thermometer.



Estimated Enrollment: 224
Study Start Date: June 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buzzy
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.
Device: Buzzy
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®

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394250

Contacts
Contact: Joel Fein, MD, MPH fein@email.chop.edu
Contact: Debra Potts, MSN, RN 215-590-7098 pottsd@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Debra Potts, MSN, RN     215-590-7098     pottsd@email.chop.edu    
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Joel Fein, MD, MPH Children's Hospital of Philadelphia
Study Director: Debra Potts, MSN, RN Children's Hospital of Philadelphia
  More Information

Publications:
Baxter AL, Leong T, Mathew B. External thermomechanical stimulation versus vapocoolant for adult venipuncture pain: pilot data on a novel device. Clin J Pain. 2009 Oct;25(8):705-10.
Kennedy RM, Luhmann J, Zempsky WT. Clinical implications of unmanaged needle-insertion pain and distress in children. Pediatrics. 2008 Nov;122 Suppl 3:S130-3. Review.
American Academy of Pediatrics. Committee on Psychosocial Aspects of Child and Family Health; Task Force on Pain in Infants, Children, and Adolescents. The assessment and management of acute pain in infants, children, and adolescents. Pediatrics. 2001 Sep;108(3):793-7.
Cummings EA, Reid GJ, Finley GA, McGrath PJ, Ritchie JA. Prevalence and source of pain in pediatric inpatients. Pain. 1996 Nov;68(1):25-31.
Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. Review.
Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(699):971-9. Review. No abstract available.
Vanderah TW. Pathophysiology of pain. Med Clin North Am. 2007 Jan;91(1):1-12. Review.
Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-83.
Kleiber C, McCarthy AM. Evaluating instruments for a study on children's responses to a painful procedure when parents are distraction coaches. J Pediatr Nurs. 2006 Apr;21(2):99-107.
Nilsson S, Finnström B, Kokinsky E. The FLACC behavioral scale for procedural pain assessment in children aged 5-16 years. Paediatr Anaesth. 2008 Aug;18(8):767-74.
Cohen LL. Behavioral approaches to anxiety and pain management for pediatric venous access. Pediatrics. 2008 Nov;122 Suppl 3:S134-9. Review.

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01394250     History of Changes
Other Study ID Numbers: 11-007970
Study First Received: June 3, 2011
Last Updated: May 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2012