External Cold and Vibration Stimulation (Buzzy®) for Procedural Pain Management in Children Undergoing Needle-Related Procedures

NCT02616419 | Completed FDA Device

• 1 other identifier: 2017-1405
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

Since the late 1980s, several studies focused on pediatric procedural pain and show that it still underevaluated and undertreated, especially in the Emergency Department (ED). Needle-related procedures are the most important source of pain and anxiety and children. Since it is impossible to completely eliminate the pain and anxiety experienced by children during painful procedures, use of non-pharmacological and/or pharmacological interventions might be beneficial. Most methods used for relief of procedural pain and anxiety for children require time or extra staff, which represent barriers to their implantation in the ED. An easy-to-use and rapid non-pharmacological intervention could overcome these constraints and optimize procedural pain and anxiety relief in children undergoing a needle-related procedure. The primary objective of this study is to determine if a device combining cold and vibration (Buzzy®) is non-inferior (no worse) than a topical anesthetic cream (lidocaine liposomal 4%) for procedural pain management in children undergoing needle-related procedures in the ED. Investigators strongly believe that the use of the Buzzy® device in the ED will improve significantly the pain and anxiety felt by children undergoing needle-related procedures. Since EDs are usually chaotic and very busy, an easy-to-use and rapid non-pharmacological intervention like the Buzzy®, will surely be adopted by the nursing personnel as a useful tool for procedural pain. Given this knowledge, the investigators feel that this randomized controlled trial will have the potential to improve nursing practice and optimize painful experiences of children undergoing needle-related procedures.

Conditions

Child; Pain Due to Certain Specified Procedures

Keywords

Emergency Department; Procedural pain; Procedural anxiety; Needle-related procedures; Clinical Nursing Research; Nursing practice; Non-pharmacological method

Outcome Measures

Primary Outcomes (1)

• Mean per-procedural pain scores

  The per-procedural pain intensity will be assess immediately after the needle-related procedure using the Color Analogue Scale (CAS) (self-report scale).

  T-3: Immediately after the-needle-related procedure

Secondary Outcomes (6)

• Mean per-procedural pain scores

  T-3: Immediately after the needle-related procedure

• Mean level of per-procedural distress

  T-2: During the needle-related procedure

• Mean level of per-procedural distress

  T-3: Immediately after the needle-related procedure

• Satisfaction regarding the use of the Buzzy® device

  T-4: 15 minutes after the needle-related procedure

• Memory of pain (mean post-procedural pain scores 24 hours after the procedure)

  T-5: 24 hours after the needle-related procedure

Study Arms (2)

Buzzy® device

EXPERIMENTAL

Just before the needle-related procedure, the Buzzy®, combining an ice pack and vibration integrated to a plastic bee, will be applied 5 cm above the needle insertion site and will be maintained in place throughout the painful procedure.

Device: Buzzy® device

Maxilene® (Lidocaine liposomal 4%)

ACTIVE COMPARATOR

Maxilene® topical anaesthetic cream will be applied 30 minutes before the needle-related procedure at the insertion site.

Drug: Maxilene® (Lidocaine liposomal 4%)

Interventions

Buzzy® device DEVICE

Just before the needle-related procedure, the Buzzy®, combining an ice pack and vibration integrated to a plastic bee, will be applied 5 cm above the needle insertion site and will be maintained in place throughout the painful procedure.

Buzzy® device

Maxilene® (Lidocaine liposomal 4%) DRUG

Maxilene® topical anaesthetic cream will be applied 30 minutes before the needle-related procedure at the insertion site.

Maxilene® (Lidocaine liposomal 4%)

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between the ages of 4 and 17 years old
• Visiting the Emergency Department
• Requiring a venipuncture or IV catheter insertion
• Able to understand and speak French or English
• Having at least one parent who can understand, read and talk in French or English

You may not qualify if:

• Neuro-cognitive disability that precludes patients from assenting and participating to the study
• Inability to self-report pain
• Critical or unstable health status

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Ste-Justine

Montreal, Quebec, Canada

Location

Related Publications (1)

• Ballard A, Khadra C, Adler S, D Trottier E, Bailey B, Poonai N, Theroux J, Le May S. External cold and vibration for pain management of children undergoing needle-related procedures in the emergency department: a randomised controlled non-inferiority trial protocol. BMJ Open. 2019 Jan 15;9(1):e023214. doi: 10.1136/bmjopen-2018-023214.

  PMID: 30782698 DERIVED

MeSH Terms

Conditions

Emergencies; Pain, Procedural

Interventions

Maxilene

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ariane Ballard, PhD Student

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 26, 2015
• Study Start: May 15, 2017
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: August 6, 2019

Record last verified: 2019-08

Locations

CA (1)