Clinical trial NCT02273284: Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®
Official title: Pain Perception of Children and Youth Receiving Non-sedated Botulinum Toxin-A Injections Using the Buzzy®
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Pain, Pediatrics, Botulinum Toxin injections, Buzzy
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Faces Pain Scale revised
timeFrame: The participants will be asked to rate their pain 3 minutes after the treatment. This will take about 2-5 minutes.
Secondary outcomes:
measure: FLACC scale (base line)
timeFrame: Baseline: Participants will be observed and rated on the FLACC scale 1 minute prior to the intervention.
measure: FLACC scale (during intervention)
timeFrame: Participants will be observed and rated on the FLACC scale during the intervention. Intervention time is typically 1-3 minutes.
measure: FLACC scale (after intervention)
timeFrame: Participants will be observed and rated on the FLACC scale 5 minutes after the intervention.
measure: Heart rate (baseline)
timeFrame: The heart rate will be captured 1 minute before the intervention
measure: Heart rate (during intervention)
timeFrame: The heart rate will be captured during the intervention.
measure: Heart rate (after intervention)
timeFrame: The heart rate will be captured 5 minutes after the intervention.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Ronit Mesterman, M.D.
role: PRINCIPAL_INVESTIGATOR
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