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

NCT02273284 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-03-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Ronit Mesterman, M.D. · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02273284 on ClinicalTrials.gov