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

NCT02273284 | Terminated

• 1 other identifier: no number yet
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain, Pediatrics, Botulinum Toxin injections, Buzzy

Outcome Measures

Primary Outcomes (1)

• Faces Pain Scale revised

  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.

  The participants will be asked to rate their pain 3 minutes after the treatment. This will take about 2-5 minutes.

Secondary Outcomes (6)

• FLACC scale (base line)

  Baseline: Participants will be observed and rated on the FLACC scale 1 minute prior to the intervention.

• FLACC scale (during intervention)

  Participants will be observed and rated on the FLACC scale during the intervention. Intervention time is typically 1-3 minutes.

• FLACC scale (after intervention)

  Participants will be observed and rated on the FLACC scale 5 minutes after the intervention.

• Heart rate (baseline)

  The heart rate will be captured 1 minute before the intervention

• Heart rate (during intervention)

  The heart rate will be captured during the intervention.

Study Arms (2)

Buzzy

EXPERIMENTAL

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

control - no Buzzy

NO INTERVENTION

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

Interventions

Buzzy DEVICE

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.

Also known as: vibration therapy

Buzzy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4 K1, Canada

Location

Related Publications (12)

• Lukban MB, Rosales RL, Dressler D. Effectiveness of botulinum toxin A for upper and lower limb spasticity in children with cerebral palsy: a summary of evidence. J Neural Transm (Vienna). 2009 Mar;116(3):319-31. doi: 10.1007/s00702-008-0175-8. Epub 2009 Jan 14.

  PMID: 19142573 BACKGROUND

• Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.

  PMID: 18387963 BACKGROUND

• Moayedi M, Davis KD. Theories of pain: from specificity to gate control. J Neurophysiol. 2013 Jan;109(1):5-12. doi: 10.1152/jn.00457.2012. Epub 2012 Oct 3.

  PMID: 23034364 BACKGROUND

• Fehlings D, Narayanan U, Andersen J, Beauchamp R, Gorter JW, Kawamura A, Kiefer G, Mason M, McCormick A, Mesterman R, Switzer L, Watt J. Botulinum toxin-A use in paediatric hypertonia: Canadian practice patterns. Can J Neurol Sci. 2012 Jul;39(4):508-15. doi: 10.1017/s0317167100014049.

  PMID: 22728860 BACKGROUND

• Whelan HM, Kunselman AR, Thomas NJ, Moore J, Tamburro RF. The impact of a locally applied vibrating device on outpatient venipuncture in children. Clin Pediatr (Phila). 2014 Oct;53(12):1189-95. doi: 10.1177/0009922814538494. Epub 2014 Jun 12.

  PMID: 24924565 BACKGROUND

• Canbulat N, Ayhan F, Inal S. Effectiveness of external cold and vibration for procedural pain relief during peripheral intravenous cannulation in pediatric patients. Pain Manag Nurs. 2015 Feb;16(1):33-9. doi: 10.1016/j.pmn.2014.03.003. Epub 2014 Jun 7.

  PMID: 24912740 BACKGROUND

• Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14.

  PMID: 22001341 BACKGROUND

• Russell K, Nicholson R, Naidu R. Reducing the pain of intramuscular benzathine penicillin injections in the rheumatic fever population of Counties Manukau District Health Board. J Paediatr Child Health. 2014 Feb;50(2):112-7. doi: 10.1111/jpc.12400. Epub 2013 Oct 18.

  PMID: 24134180 BACKGROUND

• Roy EA, Hollins M, Maixner W. Reduction of TMD pain by high-frequency vibration: a spatial and temporal analysis. Pain. 2003 Feb;101(3):267-274. doi: 10.1016/S0304-3959(02)00332-9.

  PMID: 12583869 BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.

  PMID: 11427329 BACKGROUND

• Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6.

  PMID: 23922336 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronit Mesterman, M.D.

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Neurologist, Associate professor of Pediatrics

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: October 23, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

CA (1)