External Cold and Vibration Stimulation (Buzzy® Device) VS Topical Anesthetic Cream for Procedural Pain Management in Children Undergoing Needle-Related Procedures in the Emergency Department : A Randomized Controlled Non-Inferiority Trial

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.