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

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ClinicalTrials.gov Identifier: NCT02616419
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ariane Ballard, St. Justine's Hospital

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.


Condition or disease Intervention/treatment Phase
Child Pain Due to Certain Specified Procedures Device: Buzzy® device Drug: Maxilene® (Lidocaine liposomal 4%) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: External Cold and Vibration Stimulation (Buzzy® Device) VS Topical Anesthetic Cream for Procedural Pain Management in Children Undergoing Needle-Related Procedures in the Emergency Department : A Randomized Controlled Non-Inferiority Trial
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buzzy® 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.
Device: Buzzy® 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.

Active Comparator: Maxilene® (Lidocaine liposomal 4%)
Maxilene® topical anaesthetic cream will be applied 30 minutes before the needle-related procedure at the insertion site.
Drug: Maxilene® (Lidocaine liposomal 4%)
Maxilene® topical anaesthetic cream will be applied 30 minutes before the needle-related procedure at the insertion site.




Primary Outcome Measures :
  1. Mean per-procedural pain scores [ Time Frame: T-3: Immediately after the-needle-related procedure ]
    The per-procedural pain intensity will be assess immediately after the needle-related procedure using the Color Analogue Scale (CAS) (self-report scale).


Secondary Outcome Measures :
  1. Mean per-procedural pain scores [ Time Frame: T-3: Immediately after the needle-related procedure ]
    The per-procedural pain intensity will be assess immediately after the needle-related procedure using the Faces Pain Scale-Revised (FPS-R) (self-report scale).

  2. Mean level of per-procedural distress [ Time Frame: T-2: During the needle-related procedure ]
    The level of per-procedural distress will be assess during the needle-related procedure using the Procedure Behavior Check List (PBCL) (observational scale).

  3. Mean level of per-procedural distress [ Time Frame: T-3: Immediately after the needle-related procedure ]
    The level of per-procedural distress will be assess immediately after the needle-related procedure using the Children's Fear Scale (CFS) (self-report scale).

  4. Satisfaction regarding the use of the Buzzy® device [ Time Frame: T-4: 15 minutes after the needle-related procedure ]
    The satisfaction of the nurses, children and parents regarding the use of the Buzzy® device will be assess after the needle-related procedure with questionnaires previously developped by the investigators.

  5. Memory of pain (mean post-procedural pain scores 24 hours after the procedure) [ Time Frame: T-5: 24 hours after the needle-related procedure ]
    The memory of pain will be assess 24 hours after the needle-related procedure using the Faces-Pain Scale-Revised (FPS-R) (self-report scale).

  6. Proportion of participants with success of the needle-related procedure at the first attempt [ Time Frame: T-3: Immediately after the needle-related procedure ]
    The success of the needle-related procedure at first attempt will be assess using dichotomized (yes/no) clinical data immediately after the needle-related procedure.



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616419


Locations
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Canada, Quebec
CHU Ste-Justine
Montreal, Quebec, Canada
Sponsors and Collaborators
St. Justine's Hospital
Investigators
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Principal Investigator: Ariane Ballard, PhD Student St. Justine's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ariane Ballard, PhD Student, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02616419     History of Changes
Other Study ID Numbers: 2017-1405
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ariane Ballard, St. Justine's Hospital:
Emergency Department
Procedural pain
Procedural anxiety
Needle-related procedures
Clinical Nursing Research
Nursing practice
Non-pharmacological method
Additional relevant MeSH terms:
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Pain, Procedural
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action