An interventional study of EMONO + audiovisuals tool in Pain, Acute, Child, Only and Nurse's Role, sponsored by Azienda Socio Sanitaria Territoriale di Lodi. Completed at 1 site in Italy. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Azienda Socio Sanitaria Territoriale di Lodi · Not applicable, Interventional, and Treatment
Children experience numerous painful experiences from nursing procedures: peripheral venous access placement is the main cause of procedural pain.
As much as pharmacological and nonpharmacological tools are known, their application during venipuncture is not systematic by children's hospitals.
Among pharmacological tools, the Equimolar Mixture of Nitrogen Protoxide and Oxygen (EMONO) provides adequate protection from procedural pain through inhalation of the gas mixture at least 3 minutes before the procedure.
Literature reports that the combination of nonpharmacological distractive tools and pharmacological interventions increases their analgesic effect.
The aim of the study is to measure children's cooperation during procedure (primary outcome), pain perception and side effects when EMONO is combined with audiovisuals compared with EMONO alone in peripheral venous access placement.
Exclusion Criteria:
Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) with facial mask. In the hospital EMONO is administered to all the children for procedure pain control.
Use of the Equimolar Mixture of Oxide Nitrous and Oxygen (EMONO) with facial mask and vision of audiovisual toll with smartphone or tablet. The intervention is represented by the audiovisual tool.
Other: EMONO + audiovisuals tool
EMONO + use of audiovisuals tool on smartphone or tablet
collaboration
children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016)
Time frame: 30 minutes
pain perception in 2 years-old children
pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997)
Time frame: 30 minutes
pain perception in 3 to 5 years-old children
pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988)
Time frame: 30 minutes
side effect 1
vomiting during procedure Due to not available scales, numerical values from 0 (absence of sign) to 3 (presence of sign requiring medical intervention ) will be assigned to these signs
Time frame: 30 minutes
side effect 2
gag reflex during procedure Due to not available scales, numerical values from 0 (absence of sign) to 3 (presence of sign requiring medical intervention ) will be assigned to these signs
Time frame: 30 minutes
Plan to share: No
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Azienda Socio Sanitaria Territoriale di Lodi