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Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®

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ClinicalTrials.gov Identifier: NCT02273284
Recruitment Status : Unknown
Verified August 2015 by Ronit Mesterman, Hamilton Health Sciences Corporation.
Recruitment status was:  Recruiting
First Posted : October 23, 2014
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Ronit Mesterman, Hamilton Health Sciences Corporation

Brief Summary:

The use of Botulinum toxin injections (BoNT-A) has become a standard therapy for children and youth who suffer from stiffness of their muscles due to a neurological problem. These injections are given into each muscles which require treatment, which often means receiving multiple injections in one session. Intramuscular injections are typically painful. Treatment can be provided unsedated and then should incorporate distraction and relaxation techniques, or can be alternatively be provided with the use of sedation.

To improve the pain experience the investigators want to assess the feasibility and impact on the pain perception when using a vibration device called the Buzzy during BoNT-A injections. The Buzzy creates a vibration that is applied over the injection site for 30 seconds before the injection and will be continued just above the injection site during the injection. The Buzzy has been shown to help reduce pain in procedures such as i.v. insertions and immunizations, but has not been tested in children and youth receiving multiple BoNT-A injections.


Condition or disease Intervention/treatment Phase
Pain Device: Buzzy Not Applicable

Detailed Description:

Children and youth who receive hypertonia treatment with non-sedated BoNT-A injection will be invited to participate in this clinical trial. The patients will be randomized to receiving the injection with the Buzzy versus the control group without the Buzzy. Both groups will still receive their typical supports that will include their choice of local anesthetic cream, relaxation and distraction techniques. Randomization will be stratified for the ability to self report.

Measures to capture the pain will include self report of pain, by using the Face Pain Scale revised (FPSr) in all participants who are able to self report. In addition all participants will be evaluated by the use of the Face, Legs, Activity, Cry and Consolability scale (FLACC scale), an observational tool validated to capture pain responses. The investigators will also include measurement of heart rate at rest, during and after the intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®
Study Start Date : December 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Buzzy
Participants will use the Buzzy, a small vibration device during their Botulinum toxin treatments. The Buzzy will be held over the injection site for 30 sec prior to the injection, then will be moved more rostral during the actual injection. The Buzzy will be applied in the same fashion to each targeted muscle.
Device: Buzzy
The Buzzy will be applied for 30 seconds over the area that is going to be injected, then during the actual injection the Buzzy will be moved rostrally and continuously used during the injection. When the injection is completed the Buzzy is positioned in the same way over the next injection site.
Other Name: vibration therapy

No Intervention: control - no Buzzy
Participants in the control group will receive their regular Botulinum toxin treatment without the use of the Buzzy



Primary Outcome Measures :
  1. Faces Pain Scale revised [ Time Frame: The participants will be asked to rate their pain 3 minutes after the treatment. This will take about 2-5 minutes. ]
    pain will be assessed by the use of the FPSr, a tool which was validated and been shown to be reliable in children and youth age 4 years and up.


Secondary Outcome Measures :
  1. FLACC scale (base line) [ Time Frame: Baseline: Participants will be observed and rated on the FLACC scale 1 minute prior to the intervention. ]
    The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10.

  2. FLACC scale (during intervention) [ Time Frame: Participants will be observed and rated on the FLACC scale during the intervention. Intervention time is typically 1-3 minutes. ]
    The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10.

  3. FLACC scale (after intervention) [ Time Frame: Participants will be observed and rated on the FLACC scale 5 minutes after the intervention. ]
    The FLACC scale is a validated observational measure to rate bodily responses to pain. The scale has five items. Each item observes one area/activity and includes the following: face, legs, activity, cry and consolability. Each item can get a score of 0 (no response) to 2 (most response) so that the total FLACC score can vary from 0-10.

  4. Heart rate (baseline) [ Time Frame: The heart rate will be captured 1 minute before the intervention ]
    Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain.

  5. Heart rate (during intervention) [ Time Frame: The heart rate will be captured during the intervention. ]
    Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain.

  6. Heart rate (after intervention) [ Time Frame: The heart rate will be captured 5 minutes after the intervention. ]
    Heart rate will be measured before, during and after the intervention. Heart rate has been shown to be a biological marker of stress and pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any child and youth who receives non-sedated Botulinum toxin-A injections and is interested and consenting to using the Buzzy

Exclusion Criteria:

  • Patients receiving Botulinum Toxin-A injections under sedation
  • Patients younger than 2 years or older than 18 years.

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): NCT02273284


Contacts
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Contact: Ronit Mesterman, M.D. 905-521-2100 ext 73392 mester@mcmaster.ca

Locations
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Canada, Ontario
McMaster Children's Hospital Recruiting
Hamilton, Ontario, Canada, L8S 4 K1
Contact: Ronit Mesterman, M.D.    905-521-2100 ext 73392    mester@mcmaster.ca   
Principal Investigator: Ronit Mesterman, M.D.         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Ronit Mesterman, M.D. McMaster University

Publications:

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Responsible Party: Ronit Mesterman, Pediatric Neurologist, Associate professor of Pediatrics, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02273284     History of Changes
Other Study ID Numbers: no number yet
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by Ronit Mesterman, Hamilton Health Sciences Corporation:
Pain, Pediatrics, Botulinum Toxin injections, Buzzy

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents