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

Official title

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.

Overview

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.

Interventions

• 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 a
• 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)

Primary outcome measures

• FLACC(Face-Legs-Activity-Cry-Consolability) -assessed procedural pain during peripheral intravenous catheterization [Time frame: periprocedural]

Secondary outcome measures (7)

• Procedural distress assessed using the PRIC (Procedural Restraint Intensity in Children) scale during peripheral intravenous catheterization [Time frame: skin disinfection AND Skin penetration]
• Heart rate variability as an indicator of procedural pain during peripheral intravenous catheterization [Time frame: periprocedural]
• Number of attempts required for successful peripheral venous access [Time frame: During the procedure (up to 3 attempts)]
• Assessment of parental satisfaction [Time frame: 15 minutes after the end of the procedure]
• Parental anxiety assessed using the State-Trait Anxiety Inventory (STAI) [Time frame: at the end of the procedure]
• Failure of peripheral venous access after three attempts [Time frame: periprocedural]
• Assessment of paramedical staff satisfaction [Time frame: 15 minutes after the end of the procedure.]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 5 centers

• Chu Morvan — Brest
• Centre hospitaliers de Grasse — Grasse
• Fondation Lenval Hôpitaux pédiatrique Nice CHU Lenval — Nice
• CHU de NICE — Nice
• Centre Hospitalier Universitaire Toulouse — Toulouse

Identifiers

NCT: NCT07299006 · 24-HPNCL-05 PARO · 2025-A00617-42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗