Pain, ProceduralEMLANCT04212208
Pain Assessment in the Perioperative Area
A study testing IV cannulation in people with Pain, Procedural, run by All India Institute of Medical Sciences, Rishikesh at 1 site in India.
Trial summary
This study is mainly focusing on reducing the pain scores during IV cannulation in pediatric population in the preoperative period. Applying EMLA cream is a well-known fact world wide. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pain, Procedural
- What is being tested?
- IV cannulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2019to 1 Jan 2020
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children in the preoperative period.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Assessment in the Perioperative Area During IV Cannulation Using a Combination of EMLA and Low-frequency USG Probe Versus a Combination of EMLA Cream and High-frequency Probe in Pediatric Cases- A Randomized Control Trial
This study is mainly focusing on reducing the pain scores during IV cannulation in pediatric population in the preoperative period. Applying EMLA cream is a well-known fact world wide. we would like to study the effect of ultrasound waves in the penetration of the given drung into the skin so that we could achieve the effect of the drug quickly.
Read the detailed description
To assess the intensity of pain in children in the perioperative area during IV cannulation using a combination of EMLA cream and low-frequency USG probe. To assess the intensity of pain in children in the perioperative area during IV cannulation using a combination of EMLA cream and high-frequency USG probe and final comparison between these groups will assess the effect of ultrasound in the penetration of the drug into the skin.
- Conditions
- Pain, Procedural
- Being tested
- IV cannulation
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV cannulationDevice
IV cannulation in the preoperative period
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | EMLA cream + High-frequency USG probe kept for 15minutes.After 15 minutes IV cannulation will be done and Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R) Receives: Device: IV cannulation |
| Control group | Active comparator | EMLA cream+Low frequency USG probe kept over the cream for 15 minutes. IV cannulation will be done and Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R) Receives: Device: IV cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the intensity of pain among control versus interventional groups. Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)
to check the efficacy of high-frequency ultrasound probe in comparison to low-frequency probe in aiding the drug penetration there by decreasing the pain intensity during IV cannulation
Measured: 15minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Feb 2019
- Primary completion26 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
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 Pain, ProceduralStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Rishikesh
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ADABALA VIJAY BABU, All India Institute of Medical Sciences, Rishikesh
- Investigators
- Vijay Adabala, MD, Study chair, AIIMS Rishikesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212208
- Sponsor's protocol ID
- 11
- Acronym
- EMLA
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucas VS, Burk RS, Creehan S, Grap MJ. Utility of high-frequency ultrasound: moving beyond the surface to detect changes in skin integrity. Plast Surg Nurs. 2014 Jan-Mar;34(1):34-8. doi: 10.1097/PSN.0000000000000031.
PubMed 24583666
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Assessment in the Perioperative Area During IV Cannulation Using a Combination of EMLA and Low-frequency USG Probe Versus a Combination of EMLA Cream and High-frequency Probe in Pediatric Cases- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04212208
- Acronym / sponsor ID
- EMLA / 11
- Conditions
- Pain, Procedural
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, RishikeshOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 26 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 26 Dec 2019 (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 study is mainly focusing on reducing the pain scores during IV cannulation in pediatric population in the preoperative period. Applying EMLA cream is a well-known fact world wide. we would like to study the effect of ultrasound waves in the penetration of the given drung into the skin so that we could achieve the effect of the drug quickly.
Detailed description
To assess the intensity of pain in children in the perioperative area during IV cannulation using a combination of EMLA cream and low-frequency USG probe. To assess the intensity of pain in children in the perioperative area during IV cannulation using a combination of EMLA cream and high-frequency USG probe and final comparison between these groups will assess the effect of ultrasound in the penetration of the drug into the skin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: IV cannulationEMLA cream + High-frequency USG probe kept for 15minutes.After 15 minutes IV cannulation will be done and Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R) |
| Control group | Active comparator | Device: IV cannulationEMLA cream+Low frequency USG probe kept over the cream for 15 minutes. IV cannulation will be done and Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R) |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children in the preoperative period.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IV cannulationIV cannulation in the preoperative period | Device | Control group, Intervention group |
Primary outcome
To compare the intensity of pain among control versus interventional groups. Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R)
Time frame: 15minutes
to check the efficacy of high-frequency ultrasound probe in comparison to low-frequency probe in aiding the drug penetration there by decreasing the pain intensity during IV cannulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Background: PubMed 24583666Lucas VS, Burk RS, Creehan S, Grap MJ. Utility of high-frequency ultrasound: moving beyond the surface to detect changes in skin integrity. Plast Surg Nurs. 2014 Jan-Mar;34(1):34-8. doi: 10.1097/PSN.0000000000000031.
- Individual participant dataSharing planned: No
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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.
Vijay Adabala, MD study chair
AIIMS Rishikesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV cannulation in people with Pain, Procedural, run by All India Institute of Medical Sciences, Rishikesh at 1 site in India.
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 0 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: status not confirmed, as of the sponsor's last update on 27 Dec 2019. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AJIT KUMAR, MD (9910789377, ajitdr.ajit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the intensity of pain among control versus interventional groups. Pain intensity assessment will be done using Faces Pain Scale-Revised (FPS-R) (time frame: 15minutes). 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 NCT04212208, 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 27 Dec 2019.