Procedural PainNCT05354739
Comparing Buzzy Device With Emla Cream in Needle Related Pain
An observational study of Procedural Pain, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain
- What is being tested?
- The vibration cold device (BUZZY)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 300 participants
- Where
- 1 siteQatar
- Study dates
- 2 Feb 2021to 29 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- The vibration cold device (BUZZY)
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Device: The vibration cold device (BUZZY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start2 Feb 2021
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nasser Haidar, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354739
- Sponsor's protocol ID
- MRC-01-20-053
- Status last verified
- Feb 2022
- First submitted
- 12 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37163686
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05354739
- Acronym / sponsor ID
- MRC-01-20-053
- Conditions
- Procedural Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emla Group | – | Device: The vibration cold device (BUZZY)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 Group | – | Device: The vibration cold device (BUZZY)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). |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- Older than 14 years of age or younger than 2 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Buzzy Device Group, Emla Group |
Primary outcome
To find the difference in needle related pain reduction between Buzzy Device and Emla cream using FLACC pain scale
Time frame: 1 year
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
To find the difference in anxiety reduction by using Observational Scale of Behavioral Distress (OSBD).
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 37163686Haidar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasser Haidar principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedural Pain, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To find the difference in needle related pain reduction between Buzzy Device and Emla cream using FLACC pain scale (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05354739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.