Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine whether the act of venipuncture is more successful on the first attempt using near infrared light compared to a standard puncture on children or newborn whose venous access is considered difficult due to lack of visibility of the veins.


Clinical Trial Description

This trial aims to evaluate the act of venipuncture with or without the near-infrared light device for any children requiring a venipuncture for a blood sample in neonatal intensive care and neonatology, and in pediatric emergencies. For any eligible patient, at least one parent will be approached by a member of the medical or paramedical team trained on the protocol to explain the study to him/her and to be able to include the child during the next venous blood sampling. In case the parent agrees on the child's participation, the investigator is in charge of obtaining an informed consent. During the next venous blood sampling, the nurse responsible for the patient: - Takes the next consecutively numbered randomization envelope from the room intended for this purpose. This envelope is opaque and contains the randomization group in which the child is assigned (near infrared light or standard technique) - Takes a study observation book located in the room intended for this purpose. - Once the nurse is ready to do the venipuncture and before having identified the vein to be punctured, he/she opens the envelope to find out whether or not near infrared light will be used for spotting the vein to be punctured while the person (caregiver or nurse) who will help him during the collection is present. - Venous blood sampling according to the technique indicated by the randomization (near infrared light or standard technique) for the first attempt at venipuncture. - If the first venipuncture attempt fails, the nurse can chose to carry out the 2nd or 3rd attempt with or without near infrared light. Only the first 3 attempts progress will be recorded in the observation book. - When the venous blood drawing is over, whether it is successful or not, the assistant present during the sampling completes the observation book on the sampling part. - The notebook and the envelope used are stored in the room intended for this purpose. To avoid device-related bias, the AccuVein® AV 400 (CE 0086 marking) was chosen. This device uses near infrared light to detect superficial veins under the skin and then projects an image of these veins onto the skin surface, exactly above the veins. The device will be held between 10 and 20 cm perpendicular to the skin, because at this distance the projected image corresponds to the actual size of the veins located below the skin. It will be either attached to an articulated arm in order to free the operator's hands to perform the procedure, or held by an assistant above the venipuncture site. The assistant can reorient the device during the procedure. The light from the AccuVein® device should not be aimed at the child's eyes. In neonatal intensive care and neonatology, during any use, the newborn's eyes will be covered during the procedure's implementation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05831605
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Delphine DUCOURNAU, Nurse
Phone +33 1.71.73.88.85
Email delphine.ducournau@aphp.fr
Status Recruiting
Phase N/A
Start date May 17, 2023
Completion date May 2024

See also
  Status Clinical Trial Phase
Completed NCT05374902 - Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children N/A
Completed NCT06173622 - Effects of Fetal Positioning During Venipuncture N/A
Completed NCT03139045 - Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics Phase 3
Completed NCT03122574 - The Effects of Aromatherapy on the Incidence and Severity of Acute Pain N/A
Completed NCT03004456 - Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population N/A
Completed NCT05727631 - The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture N/A
Completed NCT04027218 - Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture. N/A
Recruiting NCT05878483 - Autonomous Blood Drawing Optimization and Performance Testing N/A
Recruiting NCT05404594 - Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants N/A
Completed NCT05441241 - Leap Motion Controller for Pain During Venipuncture in Pediatrics N/A
Completed NCT05077345 - The Effects of Different Procedures on Pain Levels at Preterm and Term Infants in Neonatal Intensive Care Unit
Completed NCT04690257 - Effectiveness of Art Therapy on Reducing Pain and Anxiety in Children Receiving Venipuncture N/A
Completed NCT05680649 - Effect of Breathing Exercise During Peripheral Intravenous Catheter N/A
Completed NCT00233844 - Studying the Analgesic Mechanism of the "Cough-Trick" Phase 2
Completed NCT06077409 - ''The Effect of Skin-to-Skin Contact and Gentle Touch Method Applied During Blood Collection on Early Detection of Pain and Physiological Parameters'' N/A
Completed NCT03899766 - Support Activities for the Reduction of Distress and Pain in Children During Venipuncture
Not yet recruiting NCT04983303 - Comparison of the Effectiveness of Distraction N/A
Completed NCT01115062 - Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children Phase 2
Completed NCT04346732 - Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors N/A