Comparing Buzzy Device With Emla Cream in Needle Related Pain
Condition: Procedural Pain
MeSH terms: Pain, Procedural
Study type: Observational

Summary: 
      This randomized controlled study will enroll the eligible patients to either the Buzzy device
      arm or to the EMLA cream arm as a standard therapy. This will be done with concealment;
      however, blinding will not be practical. Will include 300 participants with 150 in each arm
      in Al Saad pediatric emergency. The research nurse will use a known valid and reliable
      measurements scales for the pain and anxiety. The data will be recorded with timing in a
      prepared form, The SPSS 22.0 and Epi-info soft wares and appropriate statistical tests will
      be used and will consider P value of <0.05 is statistically significant. The investigators
      are anticipating a Buzzy device effectiveness to be not less than the EMLA cream but the
      rapidity of effectiveness in buzzy device of around one minute compared to 30-45 minutes of
      EMLA cream will be an important outcome in a busy emergency department.
    

Detailed description: 
      Currently there is strong evidence that children regardless the age feel pain. Research were
      done and still going on to handle the barriers for pain management in children. Several pain
      management tools were established but with limitation in efficacy or practicality. EMLA
      cream, is a mixture of lidocaine and procaine, currently used for pain relief due to
      needle-related procedures but it needs minimum 30-45 minutes to work. Buzzy is a device that
      generate vibration with cold leading to pain relief in based on known theories and effective
      in a minute.

      This is non-inferiority study will compare the Buzzy device effectiveness with the EMLA
      cream, comparing the degree of the child anxiety at different stages of the procedure, and
      other secondary outcomes. Children 2-14 years of age in need for blood extraction or
      intravenous cannula insertion, based on their clinical needs, will be included. Determined
      exclusion criteria will be applied. This randomized controlled study will enroll the eligible
      patients to either the Buzzy device arm or to the EMLA cream arm as a standard therapy. This
      will be done with concealment; however, blinding will not be practical. Will include 300
      participants with 150 in each arm in Al Saad pediatric emergency. The research nurse will use
      a known valid and reliable measurements scales for the pain and anxiety. The data will be
      recorded with timing in a prepared form, The SPSS 22.0 and Epi-info soft wares and
      appropriate statistical tests will be used and will consider P value of <0.05 is
      statistically significant. The investigators are anticipating a Buzzy device effectiveness to
      be not less than the EMLA cream but the rapidity of effectiveness in buzzy device of around
      one minute compared to 30-45 minutes of EMLA cream will be an important outcome in a busy
      emergency department
    

Intervention name(s): The vibration cold device (BUZZY)
Intervention type(s): Device
Intervention description(s): If the patient fulfils the inclusions criteria, the research nurse will obtain informed consent from a parent or legal guardian and assent form if the child is 7years or older. She will assess the ability of the child to use the Faces Pain Scale-Revised (FPS-R), as a pain assessment instrument used by the child. It is a six cartoon faces showing a normal facial expression if no pain, progressing into the facial expression with very severe pain. FPS-R is graded from zero to ten; the child will be asked to quantify the pain by: no hurt, hurt, or very much hurt. This scale is widely used not only in research but also in a routine bases in ours and other units by the nursing staff and are familiar with it. The research nurse is one of the nurses used the same scale during the routine work and will be trained further to ensure consistency, she will document the findings prior, during and after the procedure. This instrument was reliable, valid, and standardized
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will be conducted in Al Saad Pediatric Emergency center (PEC) for all children
        between the age group of 2 to 14 years.