Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01394250
First received: June 3, 2011
Last updated: February 10, 2014
Last verified: February 2014
  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 FPS-R 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.



Enrollment: 240
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394250

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
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:

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: February 10, 2014
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 July 24, 2014