Pediatric Venipuncture Research Articles

Safety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial

PurposeThe goal of this study was to determine if a lidocaine hydrochloride monohydrate powder intradermal system designed to provide cutaneous analgesia is efficacious, safe, and tolerable for pediatric subjects compared with a sham placebo system. MethodsCOMFORT-004, A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects, was a single-dose, parallel group study of children undergoing venipuncture or peripheral venous cannulation at the antecubital fossa or back of the hand. Included were subjects (3–18 years) in 3 age groups: 3–7, 8–12, and 13–18 years. Excluded were those with recent similar procedures or with implantable devices or skin pathologies at the anatomical site, insufficient cognitive skills, or allergies to local anesthetics or adhesives. Subjects were randomized to receive the needle-free powder lidocaine delivery system (active system, 0.5 mg of lidocaine/21 ± 1 bar of pressure [n = 269]) or sham placebo (n = 266) 1–3 minutes before venipuncture or peripheral venous cannulation. Analgesic efficacy was assessed patient self-report of venous access pain (Wong-Baker FACES Pain Rating Scale [3–18 years] and visual analog scale [VAS; 8–18 years]) and parental observational VAS. Safety assessments included adverse events (AEs) and relationship to study treatment. Skin signs and symptoms were graded numerically. Wong-Baker FACES scores, VAS, and parental VAS were analyzed by using an ANOVA model. Responder ratings and success rates were compared by using a Cochran-Mantel-Haenszel test stratified according to center, age group, and body site. FindingsThe active system group had significantly (P = 0.0022) less pain compared with the sham placebo in all age groups combined according to the modified Wong-Baker FACES scale. Secondary efficacy analyses found that the active system resulted in less pain as assessed by subjects’ VAS pain assessments aged 8–18 years (P = 0.1856), responder analysis (P = 0.054), and parents’ VAS assessments (P = 0.002). Venous procedures were successful in 95.5% and 96.2% of the active system and sham placebo groups, respectively. Treatment-emergent AEs, most commonly nausea and/or emesis, were not significant between groups. There were no serious AEs. The active system group had significantly more minor erythema and hemorrhage/petechiae. ImplicationsThe needle-free powder lidocaine delivery system was well tolerated and produced superior analgesia compared with sham placebo when administered 1–3 minutes before pediatric venipuncture or peripheral venous cannulation. Treatment-related AEs occurred primarily at the administration site and were infrequent, generally mild, and resolved without sequelae. ClinicalTrials.gov identifier: NCT00140088.

Portable Medical Equipment Holder Assists Pediatric Venipuncture

Objectives: Phlebotomy and venous cannulation are common, technically challenging and potentiallydistressing procedures in pediatrics. The aim of this pilot study was to assess whether a novel medical equipment holdercould be a useful adjunct for venipuncture in children. Methods: Doctors and nurses at a district general hospital were asked to analyze the portable medical equipment holderand complete a questionnaire. The questionnaire consisted of twelve questions regarding seniority of the practitioner andtheir opinions of the device. Results: Fifty-three questionnaires were completed by a variety of pediatric health professionals. Overall, 98% ofparticipants rated the device as useful, 2% assumed a neutral position and no practitioner described the device as notuseful. A positive first impression was shared by 92% of the participants. A non-disposable device was preferred over thedisposable alternative. The square shape and plain colour of the prototype were considered suitable by the majority ofparticipants. Plastic was the preferred material. The modal price range suggested for a non-disposable device was £5 ($8)or less. Several modifications to the design were suggested. Conclusion: The portable medical equipment holder was well received by the pediatric staff. Design modifications putforward by the participants progressed to the development of an improved device. Further clinical research, preferably in amulti-centre study, is required.

Optimizing pediatric venipuncture: ensuring successful blood sample collection with minimal stress and pain

Methods At the Vancouver site of the CHILD study, we reviewed and compared current topical anesthetic creams used for pediatric venipuncture, specifically Ametop Gel (tetracaine hyrdrochloride gel 4%) versus EMLA (eutectic mixture of lidocaine 2.5% and prilocaine 2.5%). We conducted regular in-service training to ensure all members of the study team were informed and educated in understanding the importance of collecting the blood sample and dealing with pediatric populations at different developmental stages. Training also addressed parental anxiety related to the procedure and strategies to establish rapport and trust were shared. Finally, we developed a repertoire of comfort and distraction techniques to support the child, the parent, and the phlebotomist. We used quantitative and qualitative approaches to assess outcomes, including the number of blood samples successfully collected at the 1 and 5 year clinic visits and analysis of responses to our parent satisfaction survey evaluating perceptions of the venipuncture procedure.

The impact of a locally applied vibrating device on outpatient venipuncture in children.

To assess the impact of a locally applied vibrating device on outpatient venipuncture in children. A retrospective review of survey data collected prospectively as part of a quality improvement project. Both patients and phlebotomists were surveyed. The sample consisted of 64 children aged 4 to 18 years (29 prior to the implementation of the vibrating device and 35 afterward) and 7 phlebotomists. Prior to the use of the vibrating device, 17 children (59%) indicated that they wished something had been done to decrease venipuncture pain. Eighty percent of the cohort that used the vibrating device indicated that they would like it used for future procedures. Children with previous venipuncture experiences appeared to benefit most from use of the vibrating technique. The phlebotomists reported that vibration made the procedure easier in 81% of the cases; none reported that it complicated the procedure. Locally applied vibration appears to be a well-accepted technique to minimize pediatric venipuncture discomfort that may facilitate completion of the procedure.

When “don’t worry” communicates fear: Children’s perceptions of parental reassurance and distraction during a painful medical procedure

Children’s distress during painful medical procedures is strongly influenced by adult behavior. Adult reassurance (e.g., “it’s okay”) is associated with increased child distress whereas distraction is associated with increased child coping. It is unknown why reassurance shows this counterintuitive relationship with child distress. The present research investigated whether children perceive their parents as fearful when they reassure using complementary observational and experimental methodologies. One hundred children (40 boys, 60 girls) 5–10 years old ( M = 8.02, SD = 1.69) and their parents (86 mothers, 14 fathers) participated. First, spontaneous parent–child interactions during pediatric venipuncture were captured and used for a video-mediated recall task in which the children viewed instances of parental reassurance and distraction and rated their parents’ fear and happiness. Second, the children were asked to rate the intensity of parental fear and happiness for 12 video vignettes showing an actor posing as a parent during venipuncture. To determine whether the children’s perceptions varied with the qualities of the behavior, the vignettes manipulated: facial expression (happy vs. fearful), vocal tone (rising vs. falling), and content (informative reassurance vs. uninformative reassurance vs. distraction). For both tasks, the children provided higher ratings of fear during reassurance than distraction. In response to the vignettes, the children gave higher ratings of parental fear for a fearful facial expression, but the influence of vocal tone differed with the verbal content of the utterance. The results provide insight into the complexity of adult reassurance and highlight the important role of parental facial expression, tone, and verbal content during painful medical procedures.

Local Analgesia Within 1 to 3 Minutes for Pediatric Venipuncture and Peripheral Venous Cannulation Procedures Using Zingo (Lidocaine Hydrochloride Monohydrate), Powder Intradermal Injection System, 0.5 mg

Local Analgesia Within 1 to 3 Minutes for Pediatric Venipuncture and Peripheral Venous Cannulation Procedures Using Zingo (Lidocaine Hydrochloride Monohydrate), Powder Intradermal Injection System, 0.5 mg

Determination of lead in blood by laser ablation ICP-TOF-MS analysis of blood spotted and dried on filter paper: a feasibility study

Screening programs for pediatric lead (Pb) poisoning routinely collect blood by finger stick onto specially designed filter paper (FP) for subsequent laboratory testing. Here, laser ablation inductively coupled plasma time-of-flight mass spectrometry is evaluated as a novel method for the determination of Pb in blood spotted onto FP cards. The method requires no sample pretreatment and may be particularly suitable for rapidly screening a large number of samples. Signal intensity from the ICP-MS strongly correlated (r (2) = 0.996) with Pb target values for five blood cards from a laboratory proficiency testing program. Better precision was obtained by replicate ablation line scans (<15% rsd) compared to a grid of 25 individual ablation spots (>30% rsd). Because <2% of the sample is consumed in the laser ablation analysis, selected samples can also be analyzed by traditional techniques or archived. Lead isotope ratios determined during the same total-Pb analysis appear to be effective for discerning contamination extraneous to the blood sample. Determining that an elevated result was due to contamination may negate the need for retesting with invasive pediatric venipuncture. Some elements monitored along with Pb exhibited signal profiles conducive to potential quantitation (Ca, V, Fe, Cu Zn), whereas others did not (Cr, Mn, Co, Ni, Cd, Hg, Tl, U). Copper, Ca, and V were inversely correlated with Pb (r = -0.89, -0.90, and -0.92, respectively). Scanning electron microscope images revealed surface modality differences between FP spotted with fresh whole blood and reconstituted freeze-dried blood reference material.

Local Analgesia Within 1 to 3 Minutes for Pediatric Venipuncture and Peripheral Venous Cannulation Procedures Using the Needle-free System ALGRX 3268

Local Analgesia Within 1 to 3 Minutes for Pediatric Venipuncture and Peripheral Venous Cannulation Procedures Using the Needle-free System ALGRX 3268

“Magic feather” can aid pediatric venipuncture

(2004). “Magic feather” can aid pediatric venipuncture. Postgraduate Medicine: Vol. 115, No. 5, pp. 96-96.

The use of EMLA cream to decrease venipuncture pain in children

Venipuncture is one of the most painful medical procedures for a child, and it is one of the most frequently performed. This literature synthesis reviews evidence for the use of eutectic mixture of local anesthetics (EMLA) cream to reduce the pain children experience during venipuncture. EMLA cream was compared with placebo, iontophoresis, and amethocaine cream and was found to be an effective local anesthetic for pediatric venipuncture pain during both intravenous cannulation and phlebotomy.

Academy advocates for increased reimbursement for pediatric venipuncture

Although performing a venipuncture on patients younger than age 3 is more intense and time-consuming than for an adult, the Centers for Medicare and Medicaid Services (CMS) continues to reimburse the procedure for children at the adult level. The Academy is working to address this inequity through

Human papillomavirus infection in women: Special aspects of infectious diseases in women

The aim of this study was to determine the effect of the distraction cards, virtual reality and Buzzy® methods on venipuncture pain and anxiety in children aged 7–12 years.This was a randomized controlled trial with parallel groups conducted between November 16, 2017 and August 14, 2018 at the pediatric venipuncture unit of a university hospital in Western Turkey. The sample consisted of 142 children who met the inclusion criteria. The experimental group consisted of 108 children divided into three groups: Distraction Cards (DC; n = 35), Virtual Reality (VR; n = 37), and Buzzy® (n = 36). The control group (n = 34) received no intervention during venipuncture. Data were collected using a descriptive characteristics form, and the Visual Analog Scale (VAS), Wong-Baker FACES, and Children's Fear Scale (CFS). The participants themselves and their parents and the researcher scored venipuncture pain and anxiety levels. The study was approved by the Ethics Committee. Permission was obtained from related institutions. Informed consent was obtained from parents. Verbal consent was obtained from children prior to participation.Buzzy® group had the lowest mean VAS score (2.2 ± 2.0), followed by the VR (2.7 ± 2.8), DC (3.4 ± 2.4), and control (5.2 ± 2.8) groups (p < 0.05). According to all raters (child, parent, and researcher), the Buzzy® group had the lowest mean Wong Baker FACES score, followed by the VR, DC, and control groups (p < 0.05). According to all raters, the Buzzy® group had the lowest mean CFS score, followed by the VR, DC, and control groups (p < 0.05).The DC, VR, and Buzzy® methods were effective in reducing venipuncture pain and anxiety in children.Nurses can use the DC, VR, and Buzzy® methods to help reduce venipuncture pain and anxiety in children.The clinical trial registration number is NCT04421430. (https://clinicaltrials.gov/ct2/show/study/NCT04421430).