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

Hamilton Health Sciences (HHS)

Status: Terminated

Conditions: Pain

Treatments: Device: Buzzy

Study type: Interventional

Funder types: Other

Identifiers

NCT02273284

no number yet

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Buzzy

Experimental group

Description:

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.

Treatment:

Device: Buzzy

control - no Buzzy

No Intervention group

Description:

Participants in the control group will receive their regular Botulinum toxin treatment without the use of the Buzzy