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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMONO (usual care administered to all the children undergoing painful procedures) | No Intervention | 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. | |
| EMONO + audiovisuals tool | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMONO + audiovisuals tool | Other | EMONO + use of audiovisuals tool on smartphone or tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| collaboration | children cooperation during procedure assessed with Groningen Distress Rating Scale (Humphrey et al., 1992; Herd et al., 2006; Doumit et al., 2016) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| pain perception in 2 years-old children | pain perceprion during procedure assessed with FLACC scale (Merkel et al., 1997) | 30 minutes |
| pain perception in 3 to 5 years-old children | pain perceprion during procedure assessed with Wong-Baker scale (Wong and Baker, 1988) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Maiandi, PhDs | Azienda Socio Sanitaria Territoriale di Lodi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stefano Maiandi | Lodi | Lombardy | 26900 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40762409 | Derived | Maiandi S, Coluccia S, Ghizzardi G, Nicardi R, Giacchero R, Lusignani M, Gianni ML, Edefonti VC. Effectiveness of Equimolar Mixture of Oxygen and Nitrous Oxide Combined With Audiovisual in Young Children: A Randomised Controlled Trial. Eur J Pain. 2025 Sep;29(8):e70096. doi: 10.1002/ejp.70096. | |
| 37419632 | Derived |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 | 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 | 30 minutes |
| Maiandi S, Ghizzardi G, Edefonti V, Giacchero R, Lusignani M, Gianni ML. Is the equimolar mixture of oxygen and nitrous oxide (EMONO) associated with audiovisuals effective in reducing pain and side effects during peripheral venous access placement in children? Protocol for a single-centre randomised controlled trial from Italy. BMJ Open. 2023 Jul 7;13(7):e067912. doi: 10.1136/bmjopen-2022-067912. |