Comparing Buzzy Device With Emla Cream in Needle Related Pain

NCT ID: NCT05354739

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2021-09-29

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

Conditions

Procedural Pain

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Emla Group

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

The vibration cold device (BUZZY)

Intervention Type: DEVICE

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

Buzzy Device Group

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).

The vibration cold device (BUZZY)

Intervention Type: DEVICE

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

Interventions

The vibration cold device (BUZZY)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nasser Haidar

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Hamad Medical Corporation

Doha, , Qatar

Countries

Qatar

References

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.

Reference Type: DERIVED

PMID: 37163686 (View on PubMed)

Other Identifiers

MRC-01-20-053

Identifier Type: -

Identifier Source: org_study_id