Evaluering af Paro, en terapeutisk assistentrobot i analgesisk behandling under placering af en perifer intravenøs kateter hos spædbørn og børn. (PARO)

The child will be admitted to the emergency department.

If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin prior to the procedure.

If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, the child will inhale the gas via a mask during the procedure.

Non-pharmacological interventions, such as music therapy and/or watching cartoons, may also be used as part of standard care.

The procedure will begin with skin disinfection and identification of a suitable vein.

For the purposes of the study, the start of the procedure is defined as the moment the needle first penetrates the skin.

The procedure is considered complete once the needle is withdrawn and a dressing is applied.

Pharmacological interventions:

EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) EMLA cream (Eutectic Mixture of Local Anesthetics)

Non-pharmacological interventions:

Music therapy Audiovisual distraction (e.g., watching cartoons)

The child will be admitted to the emergency department.

If topical anesthesia (EMLA cream) is used to reduce pain, it will be applied to the skin 30 to 60 minutes prior to the procedure.

To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure.

If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child.

The procedure will begin with skin disinfection and identification of a suitable vein.

For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin.

The procedure will be considered complete once the needle is withdrawn and a dressing is applied.

The child will be admitted to the emergency department.

If topical anesthesia (EMLA cream) is used for pain prevention, it will be applied to the skin 30 to 60 minutes prior to the procedure.

To facilitate familiarization with the PARO therapeutic robot, the device will be placed on or next to the child's lap approximately 15 minutes before the start of the procedure.

If analgesia with MEOPA (equimolar mixture of oxygen and nitrous oxide) is indicated, a face mask delivering the gas will be applied to the child during the procedure.

The procedure will begin with skin disinfection and identification of a suitable vein.

For study purposes, the start of the procedure is defined as the moment the needle first penetrates the skin.

The procedure will be considered complete once the needle is withdrawn and a dressing is applied.

• PARO group

The effectiveness of PARO in reducing procedural pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale. The FLACC is a validated hetero-assessment tool for evaluating pain in children aged 12 months to 7 years, particularly in the context of acute postoperative pain and brief painful medical procedures.

This scale evaluates five behavioral domains: facial expression, leg movement, activity, crying, and consolability. Each item is scored from 0 to 2, resulting in a total score ranging from 0 to 10. A score of 0 indicates a relaxed and comfortable child, while scores of 7 to 10 indicate severe pain or significant distress. A score of ≥3 is commonly considered indicative of clinically relevant pain requiring analgesic intervention.

Heart rate variability may serve as an indirect indicator of pain intensity, reflecting autonomic (sympathetic and parasympathetic) responses to nociceptive stimulation. Heart rate is a recognized physiological marker of pain in infants and children and may increase by approximately 10 to 25 beats per minute during painful procedures.

In this study, heart rate will be used to assess the effect of PARO on procedural pain. It will be continuously monitored using standard clinical monitoring equipment. Measurements will be recorded at three time points: 15 minutes before the procedure, during PARO introduction (if applicable), and at the time of venipuncture. The primary analysis will focus on the change (delta) in heart rate between baseline (15 minutes before the procedure) and venipuncture. Comparisons will be made between study groups.

Parental anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). The STAI is a self-administered questionnaire consisting of 40 items divided into two subscales: the State Anxiety subscale (STAI Form Y-1), which assesses current anxiety levels, and the Trait Anxiety subscale (STAI Form Y-2), which assesses general predisposition to anxiety.

Each item is rated on a 4-point Likert scale, with scores ranging from 1 (low anxiety) to 4 (high anxiety).

Satisfaction of the paramedical team will be assessed using a dedicated questionnaire administered to all nursing staff involved in the study at the end of the trial. The questionnaire will be completed once by each participant and consists of four items rated on a Likert-type scale.

In addition, one or more debriefing meetings will be organized with the care team at study completion to gather qualitative feedback regarding their experience and perceptions of the intervention