Pediatric CancerPhase 4NCT06023368
Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray
A Phase 4 study testing Num Vapocoolant Spray and EMLA Cream in people with Pediatric Cancer, run by Marianne Hutti at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports. Participants will receive either the spray or cream prior to port access and rate pain on a scale. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Num Vapocoolant Spray and EMLA Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2023to 20 Jun 2024
- Phase
- Phase 4
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English-speaking
- Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy
- EMLA cream has (standard of care) or has not (vapocoolant) been applied to the port site prior to the appointment
- Previous allergic reaction or skin irritation due to EMLA
- Quick access to the child's port is needed for drawing blood, or giving treatments, blood products, or drugs such as chemotherapy
Who cannot join
- Child has a legal guardian or non-parent family member as the only adult with them for the visit.
- Children less than 4 years of age
- Children with altered mental status
- History of traumatic brain injury, developmental delay or autism
- Child is nonverbal
- Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy, and child and parents prefer to wait for EMLA cream to take effect.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky DanceBlue Pediatric Hematology/oncology clinic
Lexington, Kentucky, 40506
About this study
The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports.
Participants will receive either the spray or cream prior to port access and rate pain on a scale.
Researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.
- Conditions
- Pediatric Cancer
- Being tested
- Num Vapocoolant Spray, EMLA Cream
- Keywords
- Port access pain, pediatric, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Num Vapocoolant SprayDrug
Also called Vapocoolant Spray
Spray applied around port prior to access
EMLA CreamDrug
Also called numbing cream
cream applied around the port prior to access
| Study group | Role | What they receive |
|---|---|---|
| Sterile Vapocoolant Spray | Experimental | Num vapocoolant spray will be administered as a single use canister around the port Receives: Drug: Num Vapocoolant Spray |
| EMLA Cream | Active comparator | Numbing (EMLA) cream will be applied around the port. Receives: Drug: EMLA Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Port Access Pain
Pain will be measured by The Faces Pain Scale - Revised (FPS-R). FPS-R is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. Higher scores mean increased pain.
Measured: Within 5 minutes of port access
Clinic Wait Time
Wait time will be measured in minutes from check in to check out
Measured: Day of visit, up to 8 hours
Duration of Visit
Total length of overall appointment time measured in minutes
Measured: Day of visit, up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start23 Dec 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Why it stopped: Administrative burden
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marianne Hutti
- Sponsor type
- University, hospital or other
- Collaborators
- Bimeco Group
- Responsible party
- Sponsor-investigator, Marianne Hutti, University of Kentucky
- Investigators
- Marianne Hutti, PhD, APRN, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023368
- Sponsor's protocol ID
- 84569
- Status last verified
- Nov 2024
- First submitted
- 28 Aug 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray
- ClinicalTrials.gov ID
- NCT06023368
- Acronym / sponsor ID
- 84569
- Conditions
- Pediatric Cancer
- Keywords
- Port access pain, pediatric, oncology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative burden
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marianne HuttiUniversity, hospital or other
- Collaborators
- Bimeco Group
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 5 Sep 2023 (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.
The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports.
Participants will receive either the spray or cream prior to port access and rate pain on a scale.
Researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterile Vapocoolant Spray | Experimental | Drug: Num Vapocoolant SprayNum vapocoolant spray will be administered as a single use canister around the port |
| EMLA Cream | Active comparator | Drug: EMLA CreamNumbing (EMLA) cream will be applied around the port. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- English-speaking
- Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy
- EMLA cream has (standard of care) or has not (vapocoolant) been applied to the port site prior to the appointment
- Previous allergic reaction or skin irritation due to EMLA
- Quick access to the child's port is needed for drawing blood, or giving treatments, blood products, or drugs such as chemotherapy
Key exclusion criteria (6 listed)
- Child has a legal guardian or non-parent family member as the only adult with them for the visit.
- Children less than 4 years of age
- Children with altered mental status
- History of traumatic brain injury, developmental delay or autism
- Child is nonverbal
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 |
|---|---|---|
| Num Vapocoolant SprayAlso: Vapocoolant SpraySpray applied around port prior to access | Drug | Sterile Vapocoolant Spray |
| EMLA CreamAlso: numbing creamcream applied around the port prior to access | Drug | EMLA Cream |
Primary outcome
Port Access Pain
Time frame: Within 5 minutes of port access
Pain will be measured by The Faces Pain Scale - Revised (FPS-R). FPS-R is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. Higher scores mean increased pain.
Clinic Wait Time
Time frame: Day of visit, up to 8 hours
Wait time will be measured in minutes from check in to check out
Duration of Visit
Time frame: Day of visit, up to 8 hours
Total length of overall appointment time measured in minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Pediatric Cancer
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Not yet recruitingPhase 2
Omega-3 Supplementation vs Demodex vs Eyelid Cleanser for Pediatric Chalazia
Pediatric Chalazia
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
RecruitingPhase 1
A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)
Adult Glioblastoma, High Grade Glioma
Not yet recruiting
Pediatric Electrocutaneous Analgesia for Children Experiencing Neuropathic Pain
Neuropathic Pain, Chronic Pain
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.
Marianne Hutti, PhD, APRN principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Num Vapocoolant Spray and EMLA Cream in people with Pediatric Cancer, run by Marianne Hutti at 1 site in United States.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 14 Nov 2024. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Port Access Pain (time frame: Within 5 minutes of port access). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2024.