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

NCT07299006 | Not Yet Recruiting

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

Brief Summary

Peripheral intravenous catheterization is one of the most frequently performed procedures in children in emergency rooms and pediatric units. It often causes anxiety for both the child and their parents, which increases the pain associated with the procedure itself, as fear and pain are closely linked. Managing the child's pain and anxiety is essential to optimize the child's well-being in the short, medium, and long term. The quality of pediatric analgesia largely depends on the multimodal approach to interventions offered to children in pain. Recently, several non-pharmacological therapies for pain management and anxiety reduction have been developed. Among these techniques, new technologies have emerged, such as therapeutic assistance robots equipped with artificial intelligence, but their therapeutic benefits still need to be evaluated. The investigators therefore aim to conduct a study on PARO, a therapeutic assistance robot shaped like a baby seal, to evaluate its role in pain management during peripheral venous catheterization in children. The investigators intend to compare the therapeutic effects of PARO combined with standard techniques versus standard techniques alone during painful procedures. The objective is to determine whether the use of this therapeutic assistance robot can improve and optimize the overall management of children undergoing needle-induced skin punctures. Thus, the investigators plan a multicenter, randomized, open-label, superiority study conducted in five pediatric centers. The investigators aim to recruit 120 infants and children aged 12 months to 7 years who will undergo peripheral venous catheterization. Pain will be assessed using the FLACC (Face-Legs-Activity-Cry-Consolability) hetero-assessment scale in this age group. Secondary objectives include assessing and comparing distress in the two groups using the PRIC (Procedural Restraint Intensity for Children) tool, which measures restraint intensity, as well as monitoring heart rate variability, the number of attempts required to complete the procedure, parental anxiety via the STAI (State-Trait Anxiety Inventory) questionnaire, and finally, the satisfaction of both parents and paramedical staff.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain assessed using the FLACC (Face-Legs-Activity-Cry-Consolability) scale.

  The effectiveness of PARO in reducing pain during the procedure will be assessed using the FLACC (Face-Legs-Activity-Cry-Consolability) hetero-evaluation scale. The FLACC is a validated hetero-assessment tool used for the evaluation of pain in children aged between 12 months and 7 years old, particulary in the immediate postoperative pain and during brief pain associated with medical procedures. This scale assesses five behavioral parameters: facial expression, leg movement, activity, crying, and consolability. Each parameter 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 between 7 and 10 reflect severe pain or significant distress. A score of 3 or above is considered to be the threshold for initiating pain treatment.

  periprocedural

Secondary Outcomes (5)

• Heart rate measure

  periprocedural

• Parental anxiety assessment using the STAI (State Trait Anxiety Inventory) questionnaire.

  at the end of the procedure

• failure rate of peripheral intravenous catheterization

  periprocedural

• questionnaire of Parental satisfaction

  15 minutes after the end of the procedure

• Questionnaire of paramedical team satisfaction

  15 minutes after the end of the procedure.

Study Arms (2)

Control group : standard multimodal stratgey

ACTIVE COMPARATOR

The child will go to the emergency room. If EMLA cream is used to stop pain, it will be put on the skin 30 minutes to 1 hour before the procedure. If MEOPA is used to help with pain, the child will wear a mask with the gas. The procedure starts by cleaning the skin and finding a vein. The procedure really begins when the needle first goes into the skin. The procedure ends when the needle is taken out and a bandage is put on

Drug: non- pharmacological interventions and usual pharmacological interventions

tes group: standard multimodal Strategy with PARO robot

EXPERIMENTAL

The child will be taken to the emergency room. If EMLA cream is used to reduce pain, it will be put on the skin 30 minutes to 1 hour before the procedure. To help the child feel comfortable with PARO, the robot will be placed on or next to the child's lap 15 minutes before the procedure starts. If MEOPA is used to relieve pain, the mask with the gas will be put on the child's face. The procedure will start with cleaning the skin and looking for a vein. The procedure officially begins when the skin is first pierced. The procedure will finish when the needle is taken out and a bandage is put on.

Device: Test group : standard multimodal strategy with PARO robot

Interventions

non- pharmacological interventions and usual pharmacological interventions DRUG

Pharmacological therapies : EMONO and EMLA cream EMONO = Equimolar Mixture of Oxygen and Nitrous Oxide EMLA cream = Eutectic Mixture of Local Anesthetics cream Non-pharmacological interventions (include music therapy and watching cartoons).

Control group : standard multimodal stratgey

Test group : standard multimodal strategy with PARO robot DEVICE

The child will be taken to the emergency room. If EMLA cream is used to reduce pain, it will be put on the skin 30 minutes to 1 hour before the procedure. To help the child feel comfortable with PARO, the robot will be placed on or next to the child's lap 15 minutes before the procedure starts. If MEOPA is used to relieve pain, the mask with the gas will be put on the child's face. The procedure will start with cleaning the skin and looking for a vein. The procedure officially begins when the skin is first pierced. The procedure will finish when the needle is taken out and a bandage is put on.

tes group: standard multimodal Strategy with PARO robot

Eligibility Criteria

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

You may qualify if:

• are between 12 months and 7 years old
• require a peripheral intravenous catheterization (PIC)
• speak and understand French.

You may not qualify if:

• the need for contact isolation including colonization or infection with multidrug-resistant bacteria (MRB),
• visual or hearing impairment;
• psychiatric pathology that could impair the understanding;
• life-threatening emergency;
• the requirement for stronger analgesic drugs (such as Morphine, Ketamine, and intranasal therapeutics).

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval

Nice, 06000, France

Location

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: January 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)