Comparing Buzzy Device With Emla Cream in Needle Related Pain

NCT05354739 | Completed

• 1 other identifier: MRC-01-20-053
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Device: The vibration cold device (BUZZY)

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).

Device: The vibration cold device (BUZZY)

Interventions

The vibration cold device (BUZZY) 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; Emla Group

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

Location

Related Publications (1)

• 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.

  PMID: 37163686 DERIVED

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nasser Haidar

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 29, 2022
• Study Start: February 2, 2021
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-02

Locations

QA (1)