Child, Only, Nitrous Oxide, Nurse's Role, Pain, Acute
Conditions
Brief summary
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.
Interventions
OTHEREMONO + audiovisuals tool
EMONO + use of audiovisuals tool on smartphone or tablet
Sponsors
Azienda Socio Sanitaria Territoriale di Lodi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Age between 2 years and 5 years and 364 days * Prescription for peripheral venous access placement * Parental consent for participation in the study * Presence of at least one parent in possession of a smartphone/tablet with the ability to connect to the Internet through Wi-Fi available to users * Absence of contraindications to the administration of EMONO reported in health records * Absence of facial pathology * Presence on duty of at least one experimental nurse trained in the use of EMONO
Exclusion criteria
* Age less than 2 years and more than 5 years and 364 days * No parental consent to participate in the study * Parents not in possession of a smartphone/tablet with the ability to connect to the internet through Wi-Fi available to users * Presence of contraindications to EMONO administration * Presence of facial pathology * Oxygen therapy * Presence of tracheostomy * Absence on duty of at least one experimental nurse trained in the use of EMONO
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| collaboration | 30 minutes | children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain perception in 2 years-old children | 30 minutes | pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997) |
| pain perception in 3 to 5 years-old children | 30 minutes | pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988) |
| side effect 1 | 30 minutes | 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 |
| side effect 2 | 30 minutes | 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 |
Countries
Italy
Outcome results
None listed