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Administrative burden
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| Name | Class |
|---|---|
| Bimeco Group | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sterile Vapocoolant Spray | Experimental | Num vapocoolant spray will be administered as a single use canister around the port |
|
| EMLA Cream | Active Comparator | Numbing (EMLA) cream will be applied around the port. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Num Vapocoolant Spray | Drug | Spray applied around port prior to access |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 5 minutes of port access |
| Clinic Wait Time | Wait time will be measured in minutes from check in to check out | Day of visit, up to 8 hours |
| Duration of Visit | Total length of overall appointment time measured in minutes | Day of visit, up to 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Hutti, PhD, APRN | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky DanceBlue Pediatric Hematology/oncology clinic | Lexington | Kentucky | 40506 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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| EMLA Cream | Drug | cream applied around the port prior to access |
|
|
| Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |