Clinical trial NCT05354739: Comparing Buzzy Device With Emla Cream in Needle Related Pain
Official title: A Randomized Clinical Trail Comparing the Effect of Vibration Cold (BUZZY) Device With EMLA Cream in Decreasing the Needle-Related Pain and Anxiety in Pediatric Emergency Setting: a Non-inferiority Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Procedural Pain
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
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.

Brief 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

Eligibility criteria: Inclusion Criteria:

* All children attending Al Saad PEC with age of 2 up to 14 years of age. Decision made by the treating physician in the PEC for IV catheter placement or blood extraction

Exclusion Criteria:

* Older than 14 years of age or younger than 2 years of age.

  * Children who require immediate emergency intervention, category 1 and 2 in the Canadian Triage and Acuity Scale.
  * Diseases rendering patient to be sensitive to cold such as Sickle Cell disease or patients with Reynaud's phenomena.
  * Skin damage of any degree in the limb where the needle will be inserted.
  * Patients with abnormal sensation in the targeted limb for needle insertion.
  * Any degree of neurological, psychological, or psychiatric disability.
  * Received simple analgesics, paracetamol and nonsteroidal anti-inflammatory drugs within 6 hours prior the procedure.
  * Received procedural sedation/analgesia, any sedative, opioid analgesic, or dissociative drug such as ketamine within 4 hours from the needle prick. Known hyper sensitivity to local anesthetics or any conditions that need precautions to EMLA cream such as G-6PD deficiency, methemoglobinemia, atopic dermatitis or other skin lesion in the needle prick site, patient using antiarrhythmic drug such as amiodarone.
  * Refusal of signing the consent.Known hyper sensitivity to local anesthetics or any conditions that need precautions

Primary outcomes:
measure: To find the difference in needle related pain reduction between Buzzy Device and Emla cream using FLACC pain scale
timeFrame: 1 year
measure: To find the difference in anxiety reduction by using Observational Scale of Behavioral Distress (OSBD).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Hamad Medical Corporation
name: Nasser Haidar
role: PRINCIPAL_INVESTIGATOR
References: