Pain Management
Conditions
Keywords
pediatric
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.
Interventions
DEVICEExperimental 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.
OTHERNon-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)
Sponsors
Fondation Lenval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FLACC(Face-Legs-Activity-Cry-Consolability) -assessed procedural pain during peripheral intravenous catheterization | periprocedural | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural distress assessed using the PRIC (Procedural Restraint Intensity in Children) scale during peripheral intravenous catheterization | skin disinfection AND Skin penetration | 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 |
| Heart rate variability as an indicator of procedural pain during peripheral intravenous catheterization | periprocedural | 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 two 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. |
| Number of attempts required for successful peripheral venous access | During the procedure (up to 3 attempts) | 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. |
| Assessment of parental satisfaction | 15 minutes after the end of the procedure | 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. |
| Parental anxiety assessed using the State-Trait Anxiety Inventory (STAI) | at the end of the procedure | 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). |
| Failure of peripheral venous access after three attempts | periprocedural | 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. |
| Assessment of paramedical staff satisfaction | 15 minutes after the end of the procedure. | 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 |
Countries
France
Contacts
CONTACTALINE JOULIE, PHD
CONTACTJennifer BATTISTA, MD
PRINCIPAL_INVESTIGATORBarbara LE GALLO, MD
Hôpitaux pédiatrique Nice CHU Lenval
Outcome results
None listed