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.
Sponsor study identifier
observational
300
1 country
1
Study Start
February 2, 2021
Actual (reported)Primary Completion
September 29, 2021
Actual (reported)Study Completion
September 29, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 29, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2021
Actual (reported)September 29, 2021
Actual (reported)September 29, 2021
Actual (reported)April 12, 2022
Actual (reported)April 29, 2022
Actual (reported)To find the difference in needle related pain reduction between Buzzy Device and Emla cream using FLACC pain scale
The Face, Legs, Activity, Crying, Consolability (FLACC) scale is used as an observational scale for pain assessment by the research nurse and a parent. It composed of five behaviors, each is assessed by scoring 0 to 10, based on the pain severity
1 year
To find the difference in anxiety reduction by using Observational Scale of Behavioral Distress (OSBD).
Distress scores were calculated by summing the number of 15-second intervals during which each distress behavior occurred and multiplying that number by an expert-determined intensity weight from 1 to 4 reflecting the severity of the behavior.
1 year
Emla Cream 1 gm of EMLA cream contains lidocaine 25 mg, prilocaine 25 mg, and macrogol glycerol hydroxy stearate. Act as a surface anesthetic of the skin. Will apply ½ tube (approximately 2 gram) per 10 square cm and covered with occlusive dressing. Applied for 30-45 minutes for children needing IV catheter placement or blood extraction based on the treating physician decision depending on the patient's need
Buzzy Device The vibration cold device (BUZZY) is 8.4 cm X 5.3 cm X 2.9 cm dimensions, exist in different but the investigators will choose the most attractive color, and can be handled by the child prior the procedure It composed of two parts: * The main body which can be operated by a switch. It generates vibration using two AAA batteries. * Removable ice wings. The ice wings are reusable for about 100 times, both wings weighing 18 grams. It stays frozen at room temperature for around 10 minutes. The research nurse will follow the manufactures recommendations (MMJ labs, Atlanta, Georgia, USA).
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study will be conducted in Al Saad Pediatric Emergency center (PEC) for all children between the age group of 2 to 14 years.
Hamad Medical Corporation
Doha, 3050, Qatar
Haidar NA, Al Amri MH, Sendad NG, Toaimah FHS. Efficacy of Buzzy Device Versus EMLA Cream for Reducing Pain During Needle-Related Procedures in Children: A Randomized Controlled Trial. Pediatr Emerg Care. 2024 Mar 1;40(3):180-186. doi: 10.1097/PEC.0000000000002965. Epub 2023 May 11.
Nasser Haidar
Hamad Medical Corporation
300 participants (actual enrollment reported by the registry).
First Submitted
April 12, 2022
First Posted
April 29, 2022
Study Start
February 2, 2021
Actual (reported)Crochet Octopus in The Process of Heel Lance in Neonates
Contact the study team to confirm eligibility.
Primary Completion
September 29, 2021
Actual (reported)Study Completion
September 29, 2021
Actual (reported)Last Updated
April 29, 2022
Record last verified: 2022-02
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