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

NCT01394250 | Completed Phase 2 Results

• 1 other identifier: 11-007970
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups

  Up to 5 minutes after IV Cannulation

Study Arms (2)

Buzzy

EXPERIMENTAL

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

Topical Lidocaine 4% Cream

ACTIVE COMPARATOR

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

Interventions

Buzzy DEVICE

Cold, Vibrational Device

Buzzy

Topical Lidocaine 4% Cream DRUG

Applied to anticipated IV site at least 30 minutes prior to cannulation.

Also known as: AneCream™; Anestacon®; Dalcaine®; L-M-X™4; Xylocaine®

Topical Lidocaine 4% Cream

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (11)

• 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.

  PMID: 19920721 BACKGROUND

• 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.

  PMID: 18978006 BACKGROUND

• 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. doi: 10.1542/peds.108.3.793.

  PMID: 11533354 BACKGROUND

• Cummings EA, Reid GJ, Finley AG, McGrath PJ, Ritchie JA. Prevalence and source of pain in pediatric inpatients. Pain. 1996 Nov;68(1):25-31. doi: 10.1016/S0304-3959(96)03163-6.

  PMID: 9251995 BACKGROUND

• Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.

  PMID: 15039693 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Vanderah TW. Pathophysiology of pain. Med Clin North Am. 2007 Jan;91(1):1-12. doi: 10.1016/j.mcna.2006.10.006.

  PMID: 17164100 BACKGROUND

• 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):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 BACKGROUND

• 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. doi: 10.1016/j.pedn.2005.06.008.

  PMID: 16545670 BACKGROUND

• Nilsson S, Finnstrom 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.

  PMID: 18613934 BACKGROUND

• 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.

  PMID: 18978007 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders; Facies; Motor Activity; Crying

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Disease Attributes; Pathologic Processes; Behavior; Nonverbal Communication; Communication

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Deb Potts
• Organization: The Chidren's Hospital of Philadelphia

pottsd@email.chop.edu

215-590-7098

Study Officials

• Joel Fein, MD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Debra Potts, MSN, RN

  Children's Hospital of Philadelphia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: July 14, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 16, 2016
• Results First Posted: May 15, 2015

Record last verified: 2016-07

Locations

US (1)