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

Pain Clinical Trial

Official title:

Testing the Efficacy of a Vibrating, Cold Device for Pediatric IV Cannulation Pain Relief in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394250
• Other study ID #: 11-007970
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2011
• Last updated: May 14, 2015
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Device:
• Buzzy
Cold, Vibrational Device

Drug:
• Topical Lidocaine 4% Cream
Applied to anticipated IV site at least 30 minutes prior to cannulation.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. doi: 10.1097/AJP.0b013e3181af1236. — View Citation

Cohen LL. Behavioral approaches to anxiety and pain management for pediatric venous access. Pediatrics. 2008 Nov;122 Suppl 3:S134-9. doi: 10.1542/peds.2008-1055f. Review. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1542/peds.2008-1055e. Review. — View Citation

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. — View Citation

Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. Review. — View Citation

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. doi: 10.1111/j.1460-9592.2008.02655.x. — View Citation

Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. Review. — View Citation

Vanderah TW. Pathophysiology of pain. Med Clin North Am. 2007 Jan;91(1):1-12. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation	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).	Baseline and 30 minutes	No
Secondary	Change From Baseline in the Face, Legs, Activity, Cry, Consolability Scale (FLACC) at 30 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.	Baseline and 30 minutes	No