Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trial
Abstract The use of a rapid, easy‐to‐use intervention could improve needle‐related procedural pain management practices in the context of the Emergency Department (ED). As such, the Buzzy device seems to be a promising alternative to topical anesthetics. The aim of this study was to determine if a c...
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| Format: | Article |
| Language: | English |
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Wiley
2024-12-01
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| Series: | Paediatric & Neonatal Pain |
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| Online Access: | https://doi.org/10.1002/pne2.12125 |
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| author | Ariane Ballard Christelle Khadra Olivier Fortin Estelle Guingo Evelyne D. Trottier Benoit Bailey Naveen Poonai Sylvie Le May |
| author_facet | Ariane Ballard Christelle Khadra Olivier Fortin Estelle Guingo Evelyne D. Trottier Benoit Bailey Naveen Poonai Sylvie Le May |
| author_sort | Ariane Ballard |
| collection | DOAJ |
| description | Abstract The use of a rapid, easy‐to‐use intervention could improve needle‐related procedural pain management practices in the context of the Emergency Department (ED). As such, the Buzzy device seems to be a promising alternative to topical anesthetics. The aim of this study was to determine if a cold vibrating device was non‐inferior to a topical anesthetic cream for pain management in children undergoing needle‐related procedures in the ED. In this randomized controlled non‐inferiority trial, we enrolled children between 4 and 17 years presenting to the ED and requiring a needle‐related procedure. Participants were randomly assigned to either the cold vibrating device or topical anesthetic (4% liposomal lidocaine; standard of care). The primary outcome was the mean difference (MD) in adjusted procedural pain intensity on the 0–10 Color Analogue Scale (CAS), using a non‐inferiority margin of 0.70. A total of 352 participants were randomized (cold vibration device n = 176, topical anesthetic cream n = 176). Adjusted procedural pain scores' MD between groups was 0.56 (95% CI:−0.08–1.20) on the CAS, showing that the cold vibrating device was not considered non‐inferior to topical anesthetic. The cold vibrating device was not considered non‐inferior to the topical anesthetic cream for pain management in children during a needle‐related procedure in the ED. As topical anesthetic creams require an application time of 30 min, cost approximately CAD $40.00 per tube, are underused in the ED setting, the cold vibrating device remains a promising alternative as it is a rapid, easy‐to‐use, and reusable device. |
| format | Article |
| id | doaj-art-8066dedd6cb748519f67404d96b771a3 |
| institution | Kabale University |
| issn | 2637-3807 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Paediatric & Neonatal Pain |
| spelling | doaj-art-8066dedd6cb748519f67404d96b771a32024-12-14T15:24:25ZengWileyPaediatric & Neonatal Pain2637-38072024-12-016416417310.1002/pne2.12125Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trialAriane Ballard0Christelle Khadra1Olivier Fortin2Estelle Guingo3Evelyne D. Trottier4Benoit Bailey5Naveen Poonai6Sylvie Le May7Faculty of Nursing Université de Montréal Montréal Quebec CanadaFaculty of Nursing Université de Montréal Montréal Quebec CanadaCHU Sainte‐Justine Research Centre Montréal Quebec CanadaCHU Sainte‐Justine Research Centre Montréal Quebec CanadaDepartment of Pediatric Emergency Medicine CHU Sainte‐Justine Montréal Quebec CanadaDepartment of Pediatric Emergency Medicine CHU Sainte‐Justine Montréal Quebec CanadaDepartment of Pediatrics, Division of Pediatric Emergency Medicine, Schulich School of Medicine and Dentistry Western University London Ontario CanadaFaculty of Nursing Université de Montréal Montréal Quebec CanadaAbstract The use of a rapid, easy‐to‐use intervention could improve needle‐related procedural pain management practices in the context of the Emergency Department (ED). As such, the Buzzy device seems to be a promising alternative to topical anesthetics. The aim of this study was to determine if a cold vibrating device was non‐inferior to a topical anesthetic cream for pain management in children undergoing needle‐related procedures in the ED. In this randomized controlled non‐inferiority trial, we enrolled children between 4 and 17 years presenting to the ED and requiring a needle‐related procedure. Participants were randomly assigned to either the cold vibrating device or topical anesthetic (4% liposomal lidocaine; standard of care). The primary outcome was the mean difference (MD) in adjusted procedural pain intensity on the 0–10 Color Analogue Scale (CAS), using a non‐inferiority margin of 0.70. A total of 352 participants were randomized (cold vibration device n = 176, topical anesthetic cream n = 176). Adjusted procedural pain scores' MD between groups was 0.56 (95% CI:−0.08–1.20) on the CAS, showing that the cold vibrating device was not considered non‐inferior to topical anesthetic. The cold vibrating device was not considered non‐inferior to the topical anesthetic cream for pain management in children during a needle‐related procedure in the ED. As topical anesthetic creams require an application time of 30 min, cost approximately CAD $40.00 per tube, are underused in the ED setting, the cold vibrating device remains a promising alternative as it is a rapid, easy‐to‐use, and reusable device.https://doi.org/10.1002/pne2.12125childrencold and vibrationemergencymedical deviceneedle‐related procedurespain management |
| spellingShingle | Ariane Ballard Christelle Khadra Olivier Fortin Estelle Guingo Evelyne D. Trottier Benoit Bailey Naveen Poonai Sylvie Le May Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trial Paediatric & Neonatal Pain children cold and vibration emergency medical device needle‐related procedures pain management |
| title | Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trial |
| title_full | Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trial |
| title_fullStr | Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trial |
| title_full_unstemmed | Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trial |
| title_short | Cold and vibration for children undergoing needle‐related procedures: A non‐inferiority randomized clinical trial |
| title_sort | cold and vibration for children undergoing needle related procedures a non inferiority randomized clinical trial |
| topic | children cold and vibration emergency medical device needle‐related procedures pain management |
| url | https://doi.org/10.1002/pne2.12125 |
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