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

Fondation Lenval

Status: Not yet enrolling

Conditions: Pain Management

Treatments: Drug: non- pharmacological interventions and usual pharmacological interventions; Device: Test group : standard multimodal strategy with PARO robot

Study type: Interventional

Funder types: Other

Identifiers

NCT07299006

2025-A00617-42 (Other Identifier)

24-HPNCL-05 PARO

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control group : standard multimodal stratgey

Active Comparator group

Description:

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

Treatment:

Drug: non- pharmacological interventions and usual pharmacological interventions

tes group: standard multimodal Strategy with PARO robot

Experimental group

Description:

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.

Treatment:

Device: Test group : standard multimodal strategy with PARO robot