Best Practices for Pain Reduction Associated with Venipuncture in Children University of Alaska Anchorage NS 400 Jennifer Crow, Dawn Reishus, Brenda (Cooper) McMillan, Char Corkery, Rachel Chesser

Suggestions for Future Research Searchable Question: What are best nursing practices to reduce the pain of venipuncture in children? Background Venipuncture is found to be a common cause of pain in children. (Inal & Kelleci, 2012) Venipuncture pain in children may lead to long term avoidance of seeking health care, immunizations, and donations. (Baxter et al., 2011) Databases Searched CINAHL Cochrane Google Scholar PsychINFO Conclusion Reduction of pain in children during venipuncture will help prevent increased pain and anxiety in future procedures. Pain control methods can be achieved through various inexpensive, non-invasive means. Further education and training is advised for nursing staff regarding pain reduction techniques for children. Results Critical appraisal of the literature suggests that some form of pain control during venipuncture will be beneficial for children. Venipuncture procedures are found to be a common cause of pain in children. Pain during venipuncture may lead to long-term negative effects later in life, such as not seeking future medical care, missing immunizations, and avoiding blood donations. To determine the best nursing practices to reduce the pain of venipuncture in children, a review of the literature was performed. The nine articles reviewed included randomized controlled trails and Cochrane reviews. The articles were found using CINAHL, Cochrane, Google Scholar, and PsychINFO databases. Based on these articles, methods for decreasing venipuncture related pain in neonates to children 18 years of age included the use of distraction, sweet tasting solutions and various types of topically applied analgesics. All methods reviewed were found to be cost effective with minimum adverse effects and superior pain relief in comparison to standard interventions. It is important for nurses to be aware of and utilize the various methods of pain reduction in neonates and children. Summary of Evidence Sweet-tasting solutions significantly reduce pain of venipuncture in infants under 1 year of age (Gradin et al., 2002; Harrison et al., 2011). Amethocaine cream provided significant pain relief of venipuncture compared to EMLA cream in children 3 months - 15 years old (Lander & Weltman, 2006). Xylocaine topical spray significant reduced pain of venipuncture in neonates under 34 weeks gestation in addition to standard care (Chen et al., 2006). Jet delivery of lidocaine or a placebo provided superior pain relief to no pretreatment for children 5-18 years old (Auerbach et al., 2009). Children 6-12 years old self-reported less pain when distraction by flip-cards was used (Inal & Kelleci, 2011). External cold and vibration significantly reduced pain and anxiety in children ages 4-18 years old versus standard care (Baxter et al., 2011; Inal & Kelleci, 2012). Suggestions for Future Research Additional qualitative studies regarding various methods of pain reduction for venipuncture in children. Additional RCT studies to support use of sweet-tasting solutions for children over 1 year of age. Determine whether external cold and vibration devices could offer pain relief for more invasive procedures.

Research Question What are the best nursing practices to reduce the pain of venipuncture in children?

Background & Significance Venipuncture procedures are found to be a common cause of pain in children. (Inal & Kelleci, 2012) Venipuncture pain in children may lead to long-term negative effects later in life such as future avoidance of medical care, immunizations, and blood donations. (Baxter et al., 2011) Venipuncture is a common procedure causing pain in children. The pain that children experience can lead to life long negative effects such as avoidance of future medical care, missed immunizations, and reluctance to donate blood.

Topical Xylocaine Spray for Reducing the Pain of Venipuncture in Neonates (Chen, et al. 2006) Design: RCT, Level 2 Population: Newborn infants in the neonatal intensive care units with gestational age of more than 34 weeks (n=40) Sample: Purposive Sample/ Random Group Assignment Intervention: Administration of a 10% xylocaine solution pump spray applied topically before venipuncture. Findings: Infants in the study group had lower heart rate and less changes in oxygen saturations than infants in the control group. Chen et al. (2006) tested the effects of topical xylocaine spray for reduction of pain in infants in the neonatal intensive care units during venipuncture as opposed to infants only receiving pacifiers before the procedure. This study, a randomized controlled trial, provided Level II evidence. The sample included 40 infants in the neonatal intensive care units with gestational ages of no more than 34 weeks. Infants were selected using a purposive sample and randomly assigned into either the study group or the control group. The results shows that infants in the study group had lower heart rates and more stable oxygen saturations than infants in the control group. Strengths: it was a randomized controlled trial and the intervention was financially feasible. Weaknesses: the population was small and the researchers were assuming that heart rate, respiratory rate and oxygen saturation are associated with pain. Strengths of the Study Financially feasible intervention RCT Weaknesses of the Study Small population Assumes that heart rate, respiratory rate and oxygen saturation are associated with pain.

A Randomized, Double-blind Controlled Study of Jet Lidocaine Compared to Jet Placebo for Pain Relief in Children Undergoing Needle Insertion in the Emergency Department (Auerbach et al. 2009) Design: RCT, Double Blind Study, Level 2 Population: Children ages of 5-18 at a pediatric hospital requiring acute needle insertion (venipuncture or peripheral venous cannulation) (n=197) Sample: Convenience Sample/ Random Group Assignment Intervention: Pretreatment with jet delivered lidocaine (n=75) or a with jet-delivered placebo 60 seconds before undergoing needle insertion. (n=75) Findings: The mean needle insertion pain score for both the jet lidocaine and the jet placebo groups were lower than the needle insertion pain scores for the no device group. Auerbach et al. (2009) compared the effectiveness of pain relief for a jet delivered lidocaine pretreatment for needle insertion to a jet delivered placebo pretreatment as well as to a separate cohort that received no pretreatment during needle insertion. This study provided level 2 evidence by using a randomized double-blind control trial. A convenience sample of 197 children between the ages of 5 and 18 was used. 150 of the children were randomly assigned to be in either the jet delivered placebo or the jet delivered lidocaine groups, while the remaining 47 children were placed in the non-intervention group. Using the CAS tool to measure pain, the data showed that there was no significant difference in pain scores between the jet delivered lidocaine and the jet-delivered placebo groups. However the mean pain score for the intervention groups was lower than the pain scores for the non-intervention group. Strengths: Researchers used random double-blind control trials, the interventions were financially feasible ($2.00 per jet delivery device), large sample size the was comprised of male and female patients, and a CAS tool was used to measure pain. Weaknesses: Even though a CAS tool was used, pain is a subjective experience, parental presence or lack of was not documented for each patient and may have effected the comfort level of the children, the nonintervention group was smaller than the intervention groups, the provider’s skills in needle insertion may have varied and effected the pain scores. Strengths of the Study RCT, Double-blind study Financially feasible intervention Large sample size Patients reported pain levels using a CAS tool Weaknesses of the Study Pain scores are subjective Parental presence or lack of was not documented for each patient Nonintervention group was smaller than the intervention groups Variations in provider’s skills could impact the study.

Pain reduction at venipuncture in newborns: oral glucose compared with local anesthetic cream (Gradin et. al, 2002) Design: Experimental-controlled randomized double blind Population: 201 Newborns Interventions: Newborns receiving glucose prior to venipuncture Findings: Significantly fewer scored as having pain (19.3%) compared to EMLA group (41.7%) Strengths of the Study Decreased wait time Easy to use RCT Large sample size Financially possible. . Weaknesses of the Study Habituation to glucose Difficult to measure pain Effectiveness applies to newborns only Unknown reason why glucose works best Gradin, M., et.al (2002) conducted a qualitative experimental RCT with double blind, a level II evidence. 201 newborns (gestation >36 weeks, postnatal >24 hours but < 30 days) needing venipuncture received 1 ml 30% glucose orally or 0.5 g of EMLA. Premature Infant Pain Profile (PIPP) assessed pain levels. Significantly lower pain for glucose group 19.3%, compared with EMLA group 41.7% (P = .0007) was found. Strengths include the RCT and large sample size, and tight control of extraneous variables. Glucose is easy to use, financially possible, and short time period between administration and venipuncture is needed. Weaknesses of study include possible habituation to glucose, the controversy of measuring pain in newborns, limited generalizability, and unknown reason why glucose works.

Using non-nutritive sucking and oral glucose solution with neonates to relieve pain: A randomized controlled trial (Liu et. al, 2010) Design: Randomized, parallel group controlled trial Population: 105 neonates at least 32 weeks gestational Interventions: Newborns receiving glucose prior to venipuncture Findings: Glucose group and non nutritive sucking group had significantly lower pain scores than control group Weaknesses of the Study Limited generalizability No use of double blind Liu, M., et. al (2010) used a randomized parallel group controlled trial, a level II evidence. 105 neonates at least 32 weeks gestation, medically stable, an APGAR >7, not crying 5 minutes before receiving a venipuncture. The neonate groups included being given 2ml of 25% glucose (GW), non-nutritive sucking (NNS), or control group (CON). Neonatal Infant Pain Scale (NIPS) measured neonate pain. The NNS (B = -1.98, p < 0.001) and GW (B = -1.33, p < 0.005) had significantly lower pain scores than CON. Strengths include the use of NIPS, relevance to clinical practice is simple and convenient, and it promotes orofacial motor function and induce self regulation. Weaknesses include limited generalizability to other ages and there was no use of a double blind. Strengths of the Study Use of NIPS RCT Relevance to Clinical Practice

Sweet tasting solutions for reduction of needle-related procedural pain in children aged one to 16 years. (Harrison et al., 2011) Design: Systematic Review of RCTs, Level I Evidence Population: 4 studies and 330 children 12 months to 16 years of age Intervention: The use of sweet tasting solutions in children over one year of age during venipuncture. Findings: Sweet tasting solutions did not show a reduction in pain with needle related proceedures in children 12 months to 16 years of age. f Strengths of the Study High Level Cochrane Review Weaknesses of the Study Conflicting Studies Requires more well-conducted RCTs with larger sample sizes The Harrison et al. (2011) systematic review was conducted to determine if sweet tasting solutions or substances deliver effective, safe, and feasible pain reduction in needle-related procedures for children greater than one year of age. This review of Level I evidence, examines randomized controlled trials (RCTs) and the quality of each review was evaluated by two review authors independently, and a third review author to resolve differences through a consensus process. The review included four trials with a total of 330 children aged 12 months to 16 years old. This is a High-level Cochrane review. The use of sweet tasting solutions in children over one year of age showed to have conflicting studies making the evidence insufficient to recommend sweet tasting solutions for children beyond 1 year of age at this time. The findings support the need for more randomized controlled studies to be conducted before sweet tasting solutions are used in practice to reduce pain of needle-related procedures. 9

Distracting children during blood draw: Looking through distraction cards (Inal & Kelleci, 2012) Design: RCT, Level II Population: Children 6 – 12 years (n=123) Sample: Convenience Sample, Random Group Assignment Intervention: Flippits® Distraction Cards during blood draw procedures Findings: Children receiving intervention self-reported and were observed to have less pain and anxiety Weaknesses of the Study Not suitable for children with neurologic, visual, or auditory deficits Effectiveness after multiple uses with one child are unclear Strengths of the Study RCT, large sample Financially feasible Inal & Kelleci (2012) tested the effectiveness of the use of distraction cards (Flippits) in reducing pain and anxiety associated with venipuncture in children. The randomized control trial provided level II evidence. The sample included 123 children, ages 6-12 years. Exclusion criteria included children with a neurologic, visual or auditory deficit. The children were recruited using a convenience sample and were then randomly assigned to either the intervention or the control group. Levels of anxiety were assessed pre-procedure and post-procedure using the Children’s Anxiety and Pain Scales (CAPS). Post-procedural pain was assessed with the child’s self-report, observer and parent report using the Faces Pain Scale-Revised (FPS-R). The strengths of the study included randomization, a large sample, and a financially feasible intervention. The weaknesses included that it was not generalizable to all children and the effectiveness after multiple uses on the same child are unclear. 10

EMLA and Amethocaine for reduction of children’s pain associated with needle insertion (Review) (Lander, Weltman, & So, 2010) Design: Systematic Review of RCT, Level I Population: 6 trials of 534 children 3 months to 15 years of age Intervention: Compared EMLA to Amethocaine in reduction of pain associated with venipuncture Findings: Amethocaine significantly reduced risk of pain when compared with EMLA Strengths of the Study High-level Cochrane review Exhaustive database search and hand-search of reference lists and journals Weaknesses of the Study Some of the trials used scales that had not been properly analyzed Lander, Weltman, & So (2010) performed this systematic review to determine the effectiveness of EMLA versus Amethocaine in reducing children’s pain associated with venipuncture. This review provides level I evidence. The researchers performed an exhaustive search of over 30 databases and handsearched reference lists and journals. Each trial that met the inclusion criteria was then scored by a separate author using the Oxford Quality Scale and the ABCD concealment of allocation scale. This review includes six trials with a total of 534 children aged 3 months to 15 years of age. The findings suggested that Amethocaine significantly reduced the risked of pain when compared to EMLA. The strengths for this review include that it is a high-level Cochrane review and an exhaustive literature search was performed. Unfortunately, some of the trails used scales that had not been properly analyzed, making it difficult to ensure the validity of the scale. 11

An Integration of Vibration and Cold Relieves Venipuncture Pain in a Pediatric Emergency Department (Baxter et al., 2011) Design: RCT, Level II Population: Children 4-18 years (n=81) Sample: Convenience Sample/Random Group Assignment Intervention: The use of both cold & vibration during venipuncture Findings: Children in the device group had significantly lower pain by parent report and the observational scale than children in the standard care group In their 2011 study, Baxter et al., found that the use of both cold & vibration during venipuncture in pediatric patients reduced the pain reported by the patient, the parent and by researcher observation. Their study was a Randomized Control Trial, consisting of 81 children ages 4-18. The strengths of their findings included the design of their study, the quick-acting nature of the device vs. topical analgesics and the low cost to implement the method. Weaknesses included the small sample size, the fact that blinding was not used and there were no controls for placebo-effects. Strengths of the Study RCT Quick-acting option vs. topical analgesics Low cost ($0.09 per attempt) Weaknesses of the Study Small Sample Subjects & coders not blinded to intervention groups No control for placebo effects

Relief of Pain During Blood Specimen Collection in Pediatric Patients (Inal & Kelleci, 2012) Design: RCT, Level II Population: Children 6-12 years (n=120) Sample: Convenience Sample/Random Group Assignment Intervention: using the “Buzzy” or cold & vibration applied to the site of insertion during venipuncture Findings: Children in the device group had significantly lower pain (p<0.001) and anxiety (p<0.001) Strengths of the Study RCT Quick-acting option vs. topical analgesics Large sample size Pain & anxiety levels not assess by researcher to limit bias Weaknesses of the Study Not double-blind No control for placebo effects Nurses not randomly selected In their 2012 study, Inal & Kelleci also found that using the “Buzzy” or cold & vibration during venipuncture reduced the pain & anxiety levels in children. They sampled 120 6-12 year olds. Strengths: Randomized control trial design with a large sample size. Researcher bias was also limited d/t the fact that pain and anxiety levels were not directly measured by the researcher but by the patient’s themselves, their parents and an observer. Weaknesses: It was Not double blind, there was no control for placebo-effects and the nurses were not randomly assigned.

Stake Holders Nurses Certified Nursing Assistants Phlebotomists Intravenous Access Team Facility Administration/Accounting The stakeholders that could be effected by this project include: Nurses, certified nursing assistants, phlebotomists, intravenous access team, facility administration or accounting

Future Research Additional qualitative studies regarding various methods of pain reduction for venipuncture in children. Additional RCT studies to support use of sweet-tasting solutions for children over 1 year of age. Through our project the need for further research was identified. The research should include qualitative and quantitative studies, additional research regarding the use of sweet solutions for children over 1 year of age, and the use of the afore mentioned methods as a form of pain relief for more invasive procedures. Determine whether external cold and vibration devices could offer pain relief for more invasive procedures.

(Gradin et al., 2002; Harrison et al., 2011). Summary of Evidence Xylocaine topical spray significantly reduced the pain of venipuncture in neonates under 34 weeks gestation in addition to standard care. (Chen et al., 2006) Sweet-tasting solutions significantly reduce the pain of venipuncture in infants under one year of age. (Gradin et al., 2002; Harrison et al., 2011). The research suggests that sweet tasting solutions are effective pain reduction in children under one year of age. A topical spray, Xylocaine, was also found to significantly reduce pain in neonates.

(Baxter et al., 2011; Inal & Kelleci, 2012). Summary of Evidence Children 6-12 years old self-reported less pain when distraction by flip-cards was used (Inal & Kelleci, 2011). External cold and vibration significantly reduced pain and anxiety in children ages 4-18 years old versus standard care (Baxter et al., 2011; Inal & Kelleci, 2012). Distraction in the form of flip-cards was found to be an effective method of pain reduction in children. Another form of pain reduction for children found to be effective was the use of an external cold, vibrating device.

Summary of Evidence Amethocaine cream provided significant pain relief of venipuncture compared to EMLA cream in children 3 months - 15 years old. (Lander & Weltman, 2006) Jet delivery of lidocaine or a placebo provided superior pain relief to no pretreatment for children 5-18 years old. (Auerbach et al., 2009) Research found significant pain reduction with the use of amethocaine when compared to EMLA cream. Further research suggests that a jet delivery system, with lidocaine or a placebo, provided pain reduction in children.

Results Critical appraisal of the literature suggests that some form of pain control during venipuncture will be beneficial for children.

Implementation Create EBP quality intervention teams Provide training for staff regarding pain relief methods To implement the use of pain reducing interventions, the following methods were developed: The use of evidence based practice teams to examine the various forms of pain reduction interventions, training and continuing education credits for nurses and phlebotomists regarding the methods of pain reduction during venipuncture, and development of standards of care based on evidence based practice for hospital staff. Implement protocol for venipuncture pain relief

Evaluation Assess pain using hospital approved pain scales Document pain response to used intervention To evaluate the effectiveness of the implementation, pain should be assessed using hospital approved pain scales and proper documentation should occur. The documentation should be reviewed periodically. Periodic review of documentation regarding response to intervention

Conclusion Reduction of pain in children during venipuncture will help prevent increased pain and anxiety in future procedures. Pain control methods can be achieved through various inexpensive, non-invasive means. In conclusion, pain control during venipuncture is a prevelent issue among children. This issue must be addressed with further research examining inexpensive, non-invasive methods. Education regarding the various methods of pain reduction would provide nurses with a wide range of methods for use during venipuncture. Further education and training is advised for nursing staff regarding pain reduction techniques for children.

References Auerbach, M., Tunik, M., & Mojica, M. (2009). A randomized, double-blind controlled study of jet lidocaine compared to jet placebo for pain relief in children undergoing needle insertion in the emergency department. Academic Emergency Medicine, 16(5), 388-393. doi:10.1111/j.1553-2712.2009.00401.x Baxter, A., Cohen, L., McElvery, H., Lawson, M., & von Baeyer, C. (2011). An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatric Emergency Care, 27(12), 1151-1156. Chen, H., Tzeng, C., Liu, W., Huang, Y., & Chen, Y. (2006). Topical xylocaine spray for reducing the pain of venipuncture in neonates. Clinical Neonatology, 13(2), 38-41. Gradin, M., Eriksson, M., Holmqvist, G., Holstein, Å., & Schollin, J. (2002). Pain reduction at venipuncture in newborns: oral glucose compared with local anesthetic cream. Pediatrics, 110(6 part 1), 1053-1057. Harrison D., Yamada J., Adam-Webber T., Ohlsson A., Beyene J., & Stevens B. Sweet tasting solutions for reduction of needle-related procedual pain in children aged one to 16 years. cochrane review 2011, Issue 10

References Inal, S., & Kelleci, M. (2012). Distracting children during blood draw: Looking through distraction cards is effective in pain relief of children during blood draw. International Journal Of Nursing Practice, 18(2), 210-219. doi:10.1111/j.1440-172X.2012.02016.x İnal, S., & Kelleci, M. (2012). Relief of Pain During Blood Specimen Collection in Pediatric Patients. MCN: The American Journal Of Maternal Child Nursing, 37(5), 339-345. doi:10.1097/NMC.0b013e31825a8aa Lander JA, Weltman BJ, So SS. EMLA and Amethocaine for reduction of children's pain associated with needle insertion. Cochrane Database of Systematic Reviews 2006, Issue 3. Art. No.: CD004236. DOI: 10.1002/14651858.CD004236.pub2. Liu, M., Lin, K., Chou, Y., & Lee, T. (2010). Using non-nutritive sucking and oral glucose solution with neonates to relieve pain: A randomized controlled trial. Journal Of Clinical Nursing, 19(11-12), 1604-1611.