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NCT04695054
Buzzy Plus EMLA Cream for Vascular Access in Children
NA trial testing Buzzy device plus EMLA cream in Vascular Access in 94 participants. Completed in 1 December 2023.
1 December 2023
Quick facts
| Lead sponsor | IRCCS Burlo Garofolo |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 94 |
| Start date | 1 April 2023 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Buzzy device plus EMLA cream
- Only EMLA cream — full drug profile →
Conditions studied
- Vascular Access — all drugs for Vascular Access →
Sponsor
IRCCS Burlo Garofolo — full company profile →
Who can join
Adults 4 to 12, any sex, with Vascular Access. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in hospitalized children. The study is an open randomized controlled study. Eligible children will be randomized to receive the application of EMLA cream 60 minutes before the needle procedure or the application of EMLA 60 minutes before the procedure and the use of Buzzy device during procedure. The primary study outcome will be the mean distress score experienced by children at the moment of the procedure, evaluated with the CEMS scale. Secondary outcomes will be the mean distress score recorded by operators; the self-reported mean pain score; the mean pain score reported by parents and operators.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04695054
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Vascular Access
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- NCT06942260 — Vascular Access Registry · recruiting
- NCT06639451 — A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGE · NA · active not recruiting
- NCT06451185 — Statseal® for Central Venous Catheter Insertion Sites in Critical Care · NA · active not recruiting
Other IRCCS Burlo Garofolo trials
Trials by the same sponsor.
- NCT06895278 — Articular Damage in Patients With Juvenile Idiopathic Arthritis After Transition to Adult Care · not yet recruiting
- NCT05821569 — Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding · unknown
- NCT06310421 — Spinal Muscular Atrophy Neonatal Screening Program · recruiting
- NCT05806372 — Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy · unknown
- NCT06324578 — Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04695054 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Burlo Garofolo
- Last refreshed: 13 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04695054.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing