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

NCT07299006 | Recruiting

• 2 other identifiers: 24-HPNCL-05 PARO2025-A00617-42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Pain Management

Keywords

pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Procedural distress assessed using the PRIC (Procedural Restraint Intensity in Children) scale during peripheral intravenous catheterization

  skin disinfection AND Skin penetration

• Heart rate variability as an indicator of procedural pain during peripheral intravenous catheterization

  periprocedural

• Number of attempts required for successful peripheral venous access

  During the procedure (up to 3 attempts)

• Assessment of parental satisfaction

  15 minutes after the end of the procedure

• Parental anxiety assessed using the State-Trait Anxiety Inventory (STAI)

  at the end of the procedure

Study Arms (2)

Control group : standard multimodal stratgey

ACTIVE COMPARATOR

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.

Experimental group: Standard multimodal pain management strategy supplemented by the PARO therapeuti

EXPERIMENTAL

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.

Interventions

Experimental group: Standard multimodal pain management strategy supplemented with the PARO therapeutic robot. DEVICE

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.

Also known as: PARO group

Experimental group: Standard multimodal pain management strategy supplemented by the PARO therapeuti

Non-pharmacological and standard pharmacological interventions. OTHER

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)

Control group : standard multimodal stratgey

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (4)

Chu Morvan

Brest, France

NOT YET RECRUITING

Centre hospitaliers de Grasse

Grasse, France

NOT YET RECRUITING

Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Nice, 06000, France

RECRUITING

CHU de NICE

Nice, France

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbara LE GALLO, MD

  Hôpitaux pédiatrique Nice CHU Lenval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ALINE JOULIE, PHD

CONTACT

+33492030520; joulie.a@chu-nice.fr

Jennifer BATTISTA, MD

CONTACT

+ 33 6 36 80 27 42; battista.j@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 23, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)