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Pain Management during Port Access in Pediatric Cancer

Phase 4

Waitlist Available

Led By Marianne Hutti, PhD, APRN

Research Sponsored by Marianne Hutti

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of visit, up to 8 hours

Awards & highlights

Study Summary

This trial will compare a spray to a cream to see which is best at reducing pain from puncturing a port in kids.

Who is the study for?

This trial is for English-speaking children with cancer who need quick access to their port for treatments like blood draws, antibiotics, or chemotherapy. It's not suitable for kids under 4, nonverbal children, those preferring EMLA cream despite the wait time, or those with certain neurological conditions.Check my eligibility

What is being tested?

Researchers are testing if a vapocoolant spray can reduce pain as effectively as EMLA cream when applied before accessing a child's port. Kids will be randomly given either the spray or cream and asked to rate their pain during port puncture.See study design

What are the potential side effects?

Possible side effects may include skin irritation or allergic reactions at the site where the EMLA cream or vapocoolant spray is applied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of visit, up to 8 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of visit, up to 8 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of visit, up to 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinic Wait Time

Duration of Visit

Port Access Pain

Side effects data

From 2008 Phase 3 trial • 140 Patients • NCT00444626

56%

Injection site swelling

44%

Injection site pain

25%

Injection site bruising

21%

Injection site erythema

Injection site nodule

Injection site pruritus

Injection site anaesthesia

Injection site inflammation

Injection site papule

Injection site paraesthesia

Injection site discolouration

Injection site haemorrhage

Injection site discomfort

Injection site dryness

Injection site induration

100%

80%

60%

40%

20%

Study treatment Arm

Dermal Gel Extra (DGE): Initial Treatment Period

Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period

Restylane: Initial Treatment Period

Non-NLF: Initial Treatment Period

Dermal Gel Extra (DGE) - Repeat Treatment Period

Non-NLF: Repeat Treatment Period

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sterile Vapocoolant SprayExperimental Treatment1 Intervention

Num vapocoolant spray will be administered as a single use canister around the port

Group II: EMLA CreamActive Control1 Intervention

Numbing (EMLA) cream will be applied around the port.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Marianne HuttiLead Sponsor

Bimeco GroupUNKNOWN

Marianne Hutti, PhD, APRNPrincipal InvestigatorUniversity of Kentucky

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age threshold for entry into this trial higher than 35 years?

"This research study is seeking to enroll young people between the ages of 4 and 18."

Answered by AI

Are any slots still available for participants in this examination?

"Sadly, this clinical trial is not currently accepting new participants. The information posted on clinicialtrials.gov indicates that it was first published October 1st 2023 and last amended August 28th 2023. Despite this setback, there are still 55 other medical studies actively searching for volunteers at the moment."

Answered by AI

Has the FDA approved Sterile Vapocoolant Spray for use?

"Sterile Vapocoolant Spray is a Phase 4 treatment, meaning it has been sanctioned by the relevant authorities. Thus, our team at Power gave this medication an overall safety score of 3."

Answered by AI

For which individuals is enrollment in this investigation appropriate?

"To be considered for this pediatric cancer trial, applicants must be between 4 to 18 years old. A total of 82 participants are needed in order to meet the study's requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray

Marianne Hutti 2023. "Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023368.

All > Oncology > Pediatric Cancer