External Cold and Vibration Stimulation (Buzzy®) for Procedural Pain Management in Children Undergoing Needle-Related Procedures
Condition: Child; Pain Due to Certain Specified Procedures
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      Since the late 1980s, several studies focused on pediatric procedural pain and show that it
      still underevaluated and undertreated, especially in the Emergency Department (ED).
      Needle-related procedures are the most important source of pain and anxiety and children.
      Since it is impossible to completely eliminate the pain and anxiety experienced by children
      during painful procedures, use of non-pharmacological and/or pharmacological interventions
      might be beneficial. Most methods used for relief of procedural pain and anxiety for children
      require time or extra staff, which represent barriers to their implantation in the ED. An
      easy-to-use and rapid non-pharmacological intervention could overcome these constraints and
      optimize procedural pain and anxiety relief in children undergoing a needle-related
      procedure.

      The primary objective of this study is to determine if a device combining cold and vibration
      (Buzzy®) is non-inferior (no worse) than a topical anesthetic cream (lidocaine liposomal 4%)
      for procedural pain management in children undergoing needle-related procedures in the ED.

      Investigators strongly believe that the use of the Buzzy® device in the ED will improve
      significantly the pain and anxiety felt by children undergoing needle-related procedures.
      Since EDs are usually chaotic and very busy, an easy-to-use and rapid non-pharmacological
      intervention like the Buzzy®, will surely be adopted by the nursing personnel as a useful
      tool for procedural pain. Given this knowledge, the investigators feel that this randomized
      controlled trial will have the potential to improve nursing practice and optimize painful
      experiences of children undergoing needle-related procedures.
    

Detailed description: 
      Since the 1980s, several researches focused on paediatric procedural pain to learn more about
      its nature, its causes, its consequences, its assessment and treatment. However, decades
      later, it is still undervalued and undertreated, especially in the Emergency Department (ED).
      Thus, children experience a high level of pain and anxiety in the ED during painful
      procedures, which could be due to multiple factors: lack of knowledge regarding pain
      management interventions, lack of time, work overload, limited space and interruption in the
      continuity of care.

      Needle-related procedures (venipuncture, IV access, s/c, IM) are the most important sources
      of pain and distress in children. A study shows that only 31% of children benefit from
      procedural pain management during the insertion of an IV access and less than 1% during a
      venipuncture. Inadequate procedural pain and anxiety relief in children is not without
      consequences. These effects may be physiological, psychological and emotional and can have
      long-term impact. Since it is impossible to completely eliminate the pain and anxiety
      experienced by children during needle-related procedures, relief through non-pharmacological
      and/or pharmacological interventions is essential.

      Most relief methods of procedural pain and anxiety available for children require much time
      or staff, which represent barriers regarding their implantation in the ED. The use of a rapid
      and easy-to-use non-pharmacological intervention could overcome these constraints and
      optimize procedural pain and anxiety relief in children. In 2009, a new device (Buzzy®),
      combining cold (ice wings) and vibration (bee's body), was developed in the USA for the
      relief of pediatric procedural pain. This device relies on the Gate Control Theory as well as
      diffuse noxious inhibitory control for the modulation of pain response (Baxter et al., 2009).
      Efficacy of the Buzzy® device in pediatric patients in the ED has only been evaluated in two
      studies up to this date. Both studies showed significant results regarding control of
      post-procedural pain and post-procedural anxiety. So far, no study has been conducted in
      Canada and none has compared the effects of Buzzy. Since the 1980s, several researches
      focused on pediatric procedural pain to learn more about its nature, its causes, its
      consequences, its assessment and treatment. However, decades later, it is still undervalued
      and undertreated, especially in the Emergency Department (ED). Thus, children experience a
      high level of pain and anxiety in the ED during painful procedures, which could be due to
      multiple factors: lack of knowledge regarding pain management interventions, lack of time,
      work overload, limited space and interruption in the continuity of care.

      Needle-related procedures (venipuncture, IV access, s/c, IM) are the most important sources
      of pain and distress in children. A study shows that only 31% of children benefit from
      procedural pain management during the insertion of an IV access and less than 1% during a
      venipuncture. Inadequate procedural pain and anxiety relief in children is not without
      consequences. These effects may be physiological, psychological and emotional and can have
      long-term impact. Since it is impossible to completely eliminate the pain and anxiety
      experienced by children during needle-related procedures, relief through non-pharmacological
      and/or pharmacological interventions is essential.

      Most relief methods of procedural pain and anxiety available for children require much time
      or staff, which represent barriers regarding their implantation in the ED. The use of a rapid
      and easy-to-use non-pharmacological intervention could overcome these constraints and
      optimize procedural pain and anxiety relief in children. In 2009, a device (Buzzy®),
      combining cold (ice wings) and vibration (bee's body), was developed in the USA for the
      relief of pediatric procedural pain. This device relies on the Gate Control Theory as well as
      diffuse noxious inhibitory control for the modulation of pain response (Baxter et al., 2009).
      The few study that have evaluated its efficacy presents several limitations, such as small
      sample size and absence of intervention in control group. To date, no study has been
      conducted in Canada and none has compared its effects with the gold standard intervention for
      needle-related procedures, the topical anesthetic cream.

      Objective:

      The primary aim of this study is to determine if a device combining cold and vibration
      (Buzzy®) is non-inferior (no worse) than lidocaine liposomal 4% for procedural pain
      management in children undergoing needle-related procedures in the ED.

      Methods:

      Design: This study is a two-arm, randomized, controlled, non-inferiority trial. Setting:
      Pediatric ED in a university health center in Montreal. Inclusion criteria: Investigators
      will include children: 1) Ages from 4-17 years old; 2) Visiting the ED; 3) Requiring a
      needle-related procedure (venipuncture or IV catheter insertion); 4) Understanding and
      speaking either French or English; 5) Having at least one parent (or legal guardian) who
      understands, read and talks in French or English. Exclusion criteria: Investigators will
      exclude children with: 1) A neuro-cognitive impairment that precludes informed consent and/or
      assent, 2) An inability to self-report pain, 3) A critical or unstable health. Interventions:
      Arm 1 (Buzzy® device): Just before the needle-related procedure, the Buzzy® device (combining
      an ice pack and vibration integrated to a plastic bee) will be applied 5 cm above needle
      insertion site and will be maintained in place throughout the painful procedure. Arm 2
      (lidocaine liposomal 4%): The topical anesthetic cream will be applied 30 minutes before the
      needle-related procedure on the insertion site. Randomization and Allocation: A independent
      biostatistician will generate the sequence of randomization stratified by age (4-7; 8-12;
      13-17) and using permuted block sizes for each stratum. Enrolled participants will be
      randomly assigned to one of the two arms with a 1:1 allocation ratio. Sample size: Using a
      non-inferiority margin of 0.7 on a scale 0 to 10 for mean per-procedural pain, a total of 380
      participants (190/group) will be necessary to achieve a power of 90% at the one-sided 5%
      significance. Primary outcome: The primary outcome will be the mean per-procedural pain
      scores on the Color Analogue Scale (CAS). Secondary outcomes: a) Mean per-procedural pain
      scores on Faces-Pain Scale Revised (FPS-R), b) Mean level of per-procedural distress using
      the Procedure Behavior Check List (PBCL) and the Children's Fear Scale (CFS), c) Memory of
      pain 24 hours after the needle-related procedure on the FPS-R. d_ Proportion of children with
      success of the needle-related procedure at first attempt, e) Self-reported levels of
      satisfaction of children, parents and nurses with questionnaires previously developped by our
      team. Analyses: All analyses will be performed under both intention-to-treat and per-protocol
      principles. Regarding the primary outcome, the mean difference in pain scores between the
      experimental group ( Buzzy® device) and the control group (lidocaine liposomal 4%) along with
      its lower confidence limit will be calculated. If this limit lies within (-∞,0.7), then the
      null hypothesis of inferiority will be rejected in favor of the alternative hypothesis at the
      5% significance level. A similar approach will be used for the secondary outcomes (a, b, c).
      Proportion of children with success of the procedure at first attempt will be compared using
      a chi-square test. Descriptive statistics will be used to report data on satisfaction. ANCOVA
      will be performed on covariate to increase statistical power. Subgroups analyses will be
      performed according to age groups (4-7; 8-12; 13-17).

      Relevance :

      This proposed work will be the first RCT in Canada to assess the efficacy of the Buzzy®
      device for procedural pain and anxiety relief in children undergoing needle-related
      procedure. Very few studies of pharmacological and non-pharmacological interventions exist,
      but no intervention have been identified to be optimal for pain and anxiety management in the
      context of an ED. Investigators strongly believe that the use of the Buzzy® device in
      children undergoing needle-related procedures would optimize nursing practice and improve
      pain and anxiety experienced by children during their visit to the ED.
    

Intervention name(s): Buzzy® device; Maxilene® (Lidocaine liposomal 4%)
Intervention type(s): Device; Drug
Intervention description(s): Just before the needle-related procedure, the Buzzy®, combining an ice pack and vibration integrated to a plastic bee, will be applied 5 cm above the needle insertion site and will be maintained in place throughout the painful procedure.; Maxilene® topical anaesthetic cream will be applied 30 minutes before the needle-related procedure at the insertion site.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Emergency Department; Procedural pain; Procedural anxiety; Needle-related procedures; Clinical Nursing Research; Nursing practice; Non-pharmacological method