Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children. (PARO)

Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children, a Multicenter Randomized Prospective Study.

Peripheral intravenous catheterization is one of the most frequently performed procedures in pediatric emergency departments and hospital units. It is often associated with significant anxiety in both children and their parents, which may exacerbate the pain experienced during the procedure, as fear and pain are closely interrelated. Effective management of pain and anxiety is therefore essential to optimize the child's well-being in the short, medium, and long term.

The quality of pediatric analgesia relies on a multimodal approach combining pharmacological and non-pharmacological interventions. In recent years, several non-pharmacological strategies have been developed to reduce pain and anxiety. Among these, innovative technologies such as therapeutic assistance robots incorporating artificial intelligence have emerged; however, their clinical benefits remain to be established.

The present study aims to evaluate the effectiveness of PARO, a therapeutic assistance robot designed in the form of a baby seal, in the management of pain during peripheral intravenous catheterization in children. The investigators will compare the effects of PARO in combination with standard care versus standard care alone during needle-related procedures. The primary objective is to determine whether the use of this device improves pain management in children undergoing skin puncture.

This study is designed as a multicenter, randomized, open-label, superiority trial conducted across five pediatric centers. A total of 120 infants and children aged 12 months to 7 years undergoing peripheral intravenous catheterization will be enrolled. Pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale, which is validated for this age group.

Secondary objectives include the assessment and comparison of procedural distress between groups using the PRIC (Procedural Restraint Intensity in Children) score, evaluation of heart rate variability, number of catheterization attempts, parental anxiety measured by the STAI (State-Trait Anxiety Inventory), and satisfaction levels among both parents and healthcare staff.

Study Overview

• Status: Recruiting
• Conditions: Pain Management
• Intervention / Treatment: Other: Non-pharmacological and standard pharmacological interventions.; Device: Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ALINE JOULIE, PHD; Phone Number: +33492030520; Email: joulie.a@chu-nice.fr
• Study Contact Backup: Name: Jennifer BATTISTA, MD; Phone Number: + 33 6 36 80 27 42; Email: battista.j@chu-nice.fr

Study Locations

• France
  • Brest, France
    • Not yet recruiting
    • CHU Morvan
    • Contact: Elise SACAZE, MD; Phone Number: +33 04.92.22.36.57; Email: elise.sacaze@chu-brest.fr
  • Grasse, France
    • Not yet recruiting
    • Centre hospitaliers de Grasse
    • Contact: Blandine DESSE, MD; Phone Number: 04.92.09.75.41; Email: b.desse@chu-grasse.fr
  • Nice, France
    • Recruiting
    • CHU de Nice
    • Contact: Jennifer Battista, MD; Phone Number: +33492030039; Email: battista.j@chu-nice.fr
  • Nice, France, 06000
    • Recruiting
    • Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval
    • Contact: Aline JOULIE; Phone Number: +33492030520; Email: joulie.a@chu-nice.fr
    • Principal Investigator: Barabra LE GALLO, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 12 months and 7 years.
2. Requirement for peripheral intravenous catheterization (PIC).
3. Written informed consent obtained from at least one parent or legal guardian.
4. Affiliation with the national health insurance system (social security).

Exclusion Criteria:

1. Requirement for contact isolation, including colonization or infection with multidrug-resistant organisms (MDROs).
2. Visual or hearing impairment.
3. Known psychiatric disorder.
4. Inability to understand French.
5. Life-threatening emergency requiring immediate intervention.
6. Need for strong analgesic medication (e.g., morphine, ketamine, or intranasal analgesics).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group : standard multimodal stratgey; 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.	Other: Non-pharmacological and standard pharmacological interventions.; 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)
Experimental: Experimental group: Standard multimodal pain management strategy supplemented by the PARO therapeuti; 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.	Device: Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot.; 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.; Other Names: PARO group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC(Face-Legs-Activity-Cry-Consolability) -assessed procedural pain during peripheral intravenous catheterization	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.	periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural distress assessed using the PRIC (Procedural Restraint Intensity in Children) scale during peripheral intravenous catheterization	Children's distress will be evaluated using the PRIC scale (Procedural Restraint Intensity in Children), which measures the intensity of restraint required during pediatric procedures as an indirect indicator of procedural distress. The scale is stratified into five levels, assessing both the degree of physical restraint applied and the child's behavioral response. A score ≥3 is considered clinically significant and should prompt reassessment of pain and/or anxiolytic management. The PRIC scale has been preliminarily validated in a cohort of 20 children aged 2 months to 13 years, showing acceptable metrological properties; however, further studies are ongoing to confirm its validity in real-life clinical settings, as no gold standard currently exists. Procedural distress will be assessed at two time points: during skin disinfection with identification of the puncture site, and at skin penetration. Results will be compared between groups	skin disinfection AND Skin penetration
Heart rate variability as an indicator of procedural pain during peripheral intravenous catheterization	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.	periprocedural
Number of attempts required for successful peripheral venous access	The effectiveness of the procedure will also be assessed by the number of attempts required to establish peripheral venous access. An attempt is defined as each skin puncture attempt. For ethical reasons, a maximum of three attempts will be permitted; beyond this threshold, the procedure will be considered a failure and alternative management in the operating room will be proposed.	During the procedure (up to 3 attempts)
Assessment of parental satisfaction	Parental satisfaction will be evaluated using a structured questionnaire administered to parents following the procedure. The instrument includes four items rated on a Likert-type response scale.	15 minutes after the end of the procedure
Parental anxiety assessed using the State-Trait Anxiety Inventory (STAI)	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).	at the end of the procedure
Failure of peripheral venous access after three attempts	Failure of peripheral intravenous catheterization is defined as the inability to establish venous access after a maximum of three attempts, as previously defined, necessitating management by the anesthesia team.	periprocedural
Assessment of paramedical staff satisfaction	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	15 minutes after the end of the procedure.

Collaborators and Investigators

• Sponsor: Fondation Lenval
• Investigators: Principal Investigator: Barbara LE GALLO, MD, Hôpitaux pédiatrique Nice CHU Lenval

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pediatric
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: 24-HPNCL-05 PARO; 2025-A00617-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No