Weaning Dexmedetomidine in Non-ICU Areas: An Implementation Effort.

OBJECTIVES: To develop and implement clinical practice guidelines for safely weaning dexmedetomidine infusions in non-ICU areas. DESIGN: Development, implementation, and analysis of effectiveness of clinical practice guidelines. SETTING: Quaternary care academic free-standing pediatric hospital. PATIENTS: Children, otherwise medically ready for transfer to non-ICU areas, who were undergoing a planned wean of a dexmedetomidine infusion. INTERVENTIONS: Subject matter experts developed evidence-based guidelines for weaning dexmedetomidine in patients whose critical phase of illness had resolved. MEASUREMENTS AND MAIN RESULTS: Searches identified no prospective studies of dexmedetomidine weaning. We identified two retrospective reviews of withdrawal symptoms and one on the use of clonidine. There were case studies on withdrawal symptoms. Guidelines were piloted on a cohort of 24 patients while in the ICU. The guidelines were then implemented in non-ICU areas for patients undergoing dexmedetomidine weaning after ICU transfer. Over a 2-year period (October 1, 2018, to September 30, 2020), 63 patients (1 mo to 18 yr old) successfully weaned dexmedetomidine in non-ICU areas. The median time to discontinuation of dexmedetomidine after transfer to non-ICU areas was 5.8 days (interquartile range, 4.75-15 d). Fifty-eight percent (n = 41) of all patients were considered high risk for dexmedetomidine withdrawal based on the dose, duration of exposure, and the risk of experiencing physiologic detriment with more than mild withdrawal. Twenty-nine patients (46%) exhibited no signs or symptoms of withdrawal while weaning per guidelines. For those with signs and symptoms of withdrawal, the most common were tachycardia (n = 26, 40%), agitation (n = 9, 14%), and hypertension (n = 9, 11%). CONCLUSIONS: Weaning dexmedetomidine in non-ICU areas is feasible and can be accomplished safely even among pediatric patients at high risk for withdrawal using standardized weaning guidelines. At our institution, implementation was associated with reduced ICU length of stay for patients recovering from critical illness.

Leveraging Parent Pain Perspectives to Improve Pain Practices for Children with Medical Complexity.

PURPOSE: Children with medical complexity (MC) must rely on others to notice and address pain. Parents are aware of child pain behaviors and can serve as reliable proxy reporters. Thus, there is a critical need to understand parent perspectives to improve pain practices. DESIGN: Individual interviews were used as a data collection method in this qualitative study. METHODS: Participants were recruited via mail and social media postings. Interviews were audio-recorded and transcribed verbatim. Transcribed documents were imported to NVIVO for qualitative analysis. Conventional and directed approaches to qualitative content analysis were used. RESULTS: From the data analysis, major themes included: pain experiences, confidence in caregivers, parents are partners, proactive communication, and a spontaneous theme, "they can hear us." Emotional pain and challenges identifying the source pain were identified as sub-themes of pain experiences. CONCLUSIONS: Parents in this study shared methods helpful to identifying pain in their children, as well as suggestions for discussing pain with caregivers. Priorities for future research include identifying methods for sharing pain information that are thorough, but do not burden parents or providers. Researchers should also determine how parents and caregivers can partner to identify and address pain in children with MC. Going forward, conversations about pain should be a key part of any admission assessment or first encounter. As pain episodes among children with MC can be complex and may not always be re-created in front of a provider, nurses may advise parents to take photos or videos to share with caregivers.

Effect of a Sedation Weaning Protocol on Safety and Medication Use among Hospitalized Children Post Critical Illness.

BACKGROUND: Best practice guidelines for the safe and compassionate care of critically ill children necessitates the use of sedation to ensure adequate ventilation, patient safety and comfort. Prolonged use of sedation can result in tolerance, physical dependence and iatrogenic withdrawal syndrome if medications are weaned too quickly. PROBLEM: In the context of medication errors related to parent administration of outpatient sedation weans, we set out to improve the safety of children weaning from sedatives. METHODS: A retrospective analysis was completed. Quality improvement was guided by using Plan-Do-Study-Act cycles. INTERVENTIONS: An evidence-based post PICU sedation weaning guideline was created and implemented over time with ongoing education, and review of progress with staff members with pre-post evaluation. RESULTS: Post intervention, there were significant differences in the numbers of patients discharged on home weaning from both opioids and benzodiazepines (11%, n = 24/219 pre; 3%, n = 7/233 post; p < 0.005). The number of patients discharged with a methadone wean decreased (7%, n = 16/219 pre; 0%, 0/233 post; p = 0.03). Despite these differences, there were no significant differences in the median hospital length of stay (42 pre; 39 post; p = 0.35). Post implementation more children had mild to moderate symptoms of withdrawal (11% pre; 21% post; p < 0.005) as compared to pre-implementation, however, the percentage of severe symptoms remained consistently low (0.6% pre; 1% post; p = 0.11). CONCLUSIONS: Implementation of an evidence-based post PICU weaning guideline significantly reduced the number of patients discharged on potentially dangerous medications with modest increases in mild-moderate symptoms of withdrawal and no significant change in length of stay or the incidence of severe symptoms of withdrawal.

Nurse Practitioner-Administered Chloroprocaine in Children with Postoperative Pain.

BACKGROUND: Pain is a complex physical and emotional experience. Therefore, assessment of acute pain requires self-report when possible, observations of emotional and behavioral responses and changes in vital signs. Peripheral nerve and epidural catheters often provide postoperative analgesia in children. Administration of chloroprocaine (a short acting local anesthetic) via a peripheral nerve or epidural catheter allows for a comparison of pain scores, observations of emotional and behavioral responses and changes in vital signs to determine catheter function. AIMS: The aims of this study are to describe the use chloroprocaine injections for testing catheters; patient response; and how changes to pain management are guided by the patient response. METHODS: This study describes the use of chloroprocaine injections to manage pain and assess the function of peripheral nerve or epidural catheters in a pediatric population. We examined 128 surgical patients, (0-25 years old), who received chloroprocaine injections for testing peripheral nerve or epidural catheters. Patient outcomes included: blood pressure, respiratory rate, heart rate and pain intensity scores. RESULTS: There were no significant adverse events. The injection guided intervention by determining the function of regional analgesia in the majority (98.5%) of patients. DISCUSSION: Chloroprocaine injections appear to be useful to evaluate functionality of peripheral nerve and epidural catheters after surgery in a pediatric population.

Patient Controlled Analgesia for Vaso-Occlusive Episodes in Children: A Retrospective Study.

OBJECTIVE: To describe Patient-Controlled Analgesia (PCA) administration in pediatric patients admitted with sickle cell vaso-occlusive episode (VOE). METHODS: This single-center retrospective study included all inpatient hematology admissions for VOE between 2014 and 2020. PCA-ratio was calculated as the ratio of bolus over continuous IV opioids dose, and time to PCA adjustment as time between first PCA order and a subsequent order that increased dosing or changed opioid medication. RESULTS: A total of 866 encounters (172 unique patients) with PCA for VOE were included. The mean age was 15.4 years old (SD = 5.0). On average, after admission (hospital arrival), the first opioid dose was given at 1 hour, PCA started at 3.5 hours, and mean length of stay was 4.3 days (SD = 2.5). The mean initial PCA-ratio was 1.7 (SD = 0.6). There were no significant associations between age, gender, initial pain score, or admission hemoglobin and PCA-ratio (linear regression model P = 0.443). In 24.7% of encounters, the PCA was adjusted within 6 hours. After adjusting by age and gender, lower admission pain scores (OR = 1.15, P = 0.004), lower PCA-ratio (OR = 2.1, P = 0.003), longer time to PCA start (OR = 1.2, P = 0.001), and no adjuvant ketamine (OR = 2.4, P < 0.001) were associated with PCA unadjusted within 6 hours. CONCLUSION: At our institution, patients with VOE received opioids and PCA within the first hours of admission. PCAs were started at a ratio of 1.5-1.8, considered normal continuous. While no specific PCA-ratio was clearly superior for pain control, lower ratios (high continuous infusion) were associated with not requiring PCA adjustments at 6 hours. Prospective studies are needed.

Standardizing Opioid Prescribing in a Pediatric Hospital: A Quality Improvement Effort.

BACKGROUND: Opioids are indicated for moderate-to-severe pain caused by trauma, ischemia, surgery, cancer and sickle cell disease, and vaso-occlusive episodes (SCD-VOC). There is only limited evidence regarding the appropriate number of doses to prescribe for specific indications. Therefore, we developed and implemented an opioid prescribing algorithm with dosing guidelines for specific procedures and conditions. We aimed to reach and sustain 90% compliance within 1 year of implementation. METHODS: We conducted this quality improvement effort at a pediatric academic quaternary care institution. In 2018, a multidisciplinary team identified the need for a standard approach to opioid prescribing. The algorithm guides prescribers to evaluate the medical history, physical examination, red flags, pain type, and to initiate opioid-sparing interventions before prescribing opioids. Opioid prescriptions written between January 2015 and September 2020 were included. Examples from 2 hospital departments will be highlighted. Control charts for compliance with guidelines and variability in the doses prescribed are presented for selected procedures and conditions. RESULTS: Over 5 years, 83 037 opioid prescriptions in 53 804 unique patients were entered electronically. The encounters with ≥1 opioid prescription decreased from 48% to 25% between 2015 and 2019. Compliance with the specific guidelines increased to ∼85% for periacetabular osteotomies and SCD-VOC and close to 100% for anterior-cruciate ligament surgery. In all 3 procedures and conditions, variability in the number of doses prescribed decreased significantly. CONCLUSION: We developed an algorithm, guidelines, and a process for improvement. The number of opioid prescriptions and variability in opioid prescribing decreased. Future evaluation of specific initiatives within departments is needed.

Trends in Gabapentin and Pregabalin Prescribing in a Tertiary Pediatric Medical Center.

OBJECTIVES: Analgesic medications are commonly prescribed in pediatrics, with prescribing practices frequently extrapolated from adult trials. Gabapentinoids (gabapentin and pregabalin) are widely used as analgesics but are labeled in pediatrics only for epilepsy. We aim to (1) define trends in pediatric gabapentinoid prescribing (label and off-label) over 7 years, and (2) evaluate use in chronic pain clinic (CPC) patients during 2018. METHODS: Retrospective data from a tertiary-care pediatric hospital were collected between 2013 and 2019. Annual numbers of gabapentinoid prescriptions were stratified by prescriber specialty. Additional information about gabapentinoid prescribing in the CPC was manually collected from initial clinic notes in 2018. RESULTS: There were 15 808 outpatient prescriptions for gabapentinoids among 5172 patients over 7 years. Of these, 93% were gabapentin and 7% were pregabalin. Numbers of patients receiving gabapentin and pregabalin prescriptions increased by 1.4- and 1.3-fold, respectively, between 2013 and 2019. Few prescriptions were done for patients with a previous epilepsy diagnosis (in 2019, 16% for gabapentin and 13% for pregabalin). Approximately 28% of 650 CPC new patients were prescribed gabapentin or pregabalin before referral. Among those, 44% had discontinued the medication because of adverse events (35%), inefficacy (46%), or both (5%). Most side effects reported were mild to moderate. Diagnoses at first visit were diverse, not limited to neuropathic pain conditions, and did not differ between patients receiving or not receiving gabapentinoid prescriptions. CONCLUSIONS: In our hospital, gabapentinoids are commonly prescribed off-label for diverse indications, including chronic pain. Future research is needed to evaluate gabapentinoid efficacy in these indications.

Initial Validation of GRASP: A Differential Diagnoses Algorithm for Children With Medical Complexity and an Unknown Source of Pain.

OBJECTIVES: Identifying the source of pain for children with medical complexity (MC) is challenging. The purpose of this study was the initial validation of a tool to guide the medical evaluation for identifying the source of pain in children with MC by using differential diagnoses. The tool is entitled Guidelines for Ruling Out and Assessing Source of Pain (GRASP). METHODS: A mixed-methods approach that included expert review, focus groups, Web-based surveys, and a trial of the GRASP was used to determine validity as well as perceived clinical utility. RESULTS: Focus groups were held with 26 inpatient and outpatient clinicians. Participants consistently responded in support of the GRASP. Participants advised several suggestions for tool organization such as designing the tool as a flow diagram. Seven clinicians participated in Web-based surveys and made specific suggestions for making the GRASP more comprehensive. Six participants trialed the GRASP for 14 children with MC and pain of unknown origin. Overall, participants found that the GRASP was a clinically effective tool for guiding medical evaluation. CONCLUSIONS: These results provide preliminary evidence that the GRASP has content and face validity in evaluating the source of pain in children with MC. This tool can be used to systematically guide clinicians through a balanced approach to evaluation with a goal of determining the pain source, preventing harm, and relieving suffering without unnecessary tests.

The Use of Music by Adolescents and Young Adults With Sickle Cell Disease.

Pain is common and often severe in people with sickle cell disease (SCD), occurring as acute intermittent pain episodes called vaso-occlusive episodes (VOEs), as well as chronic pain conditions including bone infarctions, avascular necrosis of joints, and neuropathic pain. Analgesics such as opioids, nonsteroidal anti-inflammatory medications (NSAIDS), and anticonvulsants for neuropathic pain, although often necessary to manage these types of pain, are associated with side effects. Nonpharmacologic interventions such as to listening to music and music therapy may reduce pain. The objectives of this study were to determine whether the use of music by adolescents and young adults with SCD was helpful, and if so, the types of music that helped, and how music helped them. A convenience sample of nine English-speaking inpatients ages 13 to 21 years, with SCD and at least two prior hospitalizations for VOE, took part in interviews with music therapists. Participants were asked open-ended questions about both pain and music. Participants identified that music was helpful for pain relief as well as for mood regulation, focusing attention during cognitive tasks such as homework, distraction, relaxation, and feeling understood or connected with others. Despite this, while hospitalized, participants reported that they did not tend to use music to help with pain. These findings support the use of both music medicine and music therapy as interventions for pain and distress in adolescents and young adults with SCD.

CE: Original Research: Pain in Nonverbal Children with Medical Complexity: A Two-Year Retrospective Study.

: Purpose: Children with medical complexity experience frequent pain. But it can be challenging to recognize unexpected behaviors as pain related, especially in the absence of self-report. Often these children undergo extensive workups aimed at diagnosing the sources of pain. This study had three objectives: to describe the signs and symptoms parents of nonverbal children with medical complexity found worrisome, to describe the sources of pain in these children, and to describe nursing pain assessment practices in this population. DESIGN AND METHODS: Retrospective chart review was used to identify the initial presenting symptoms, sources of pain, and nursing documentation for 46 children with medical complexity who were admitted with a chief concern of pain to a 395-bed pediatric teaching hospital in the northeastern United States. RESULTS: Irritability, pain, feeding intolerance, and "not acting like herself [or himself]" were common parent-reported symptoms that prompted further evaluation. On average, five diagnostic studies were taken to identify a source of pain, and four specialty services were consulted during the admission. Nursing assessments of pain were documented approximately every three hours; the mean pain intensity score documented was 1.1 out of 10. The discharge diagnoses included infection (including urinary tract infection), seizures, constipation, chronic pain, failure to thrive, dehydration, and subdural hematoma. CONCLUSIONS: The discharge diagnoses covered a wide range. A systematic approach to pain evaluation could help to ensure that the diagnostic process is both thorough and efficient. Common childhood ailments such as constipation or urinary tract infection, as well as other causes, must be considered when diagnosing pain in this population. Practice implications include consulting parents regarding changes in a child's behavior.

In Defense of Routine Inpatient Pain Assessment.

Getting rid of the fifth vital sign won't solve the opioid abuse crisis.

Gabapentin for management of recurrent pain in 22 nonverbal children with severe neurological impairment: a retrospective analysis.

BACKGROUND: Children with severe impairment of the central nervous system (CNS) have a high incidence of distressing symptoms, with many experiencing frequent recurrent pain episodes. OBJECTIVE: The study objective was to describe presenting pain behaviors, daily dose, and response to gabapentin for the management of frequent recurrent pain in this population. METHODS: A retrospective analysis was performed with data from 22 children with severe impairment of the CNS residing at a long-term care facility, treated with gabapentin for recurrent pain behaviors. Response was considered significant if the frequency and severity of symptoms decreased by more than 50% as assessed by nursing staff. RESULTS: Pain behaviors commonly reported included facial grimacing, crying, or moaning. Intermittent increase in muscle tone was identified in 86% (n=19). Gastrointestinal (GI) symptoms occurred in 64% (n=14), including pain localized to the GI tract and vomiting. All were assessed for nociceptive pain sources, many with repeated testing. Most were on medications for spasticity (n=20, 91%) and gastroesophageal reflux disease (GERD) (n=22, 100%) prior to gabapentin use. Of the 22 treated with gabapentin, 21 (91%) had a significant decrease in symptoms. No serious adverse events occurred. The mean gabapentin dose for children five years of age or less (n=11) was 50 mg/kg/day (95% CI 45-56) compared to children older than 11 years (n=11) with a mean dose of 36 mg/kg/day (95% CI 34-38). CONCLUSIONS: Gabapentin appears to be an effective treatment for children with severe impairment of the CNS and recurrent pain behaviors, including intermittent changes in muscle tone. Dosing information can guide treatment trials and future prospective studies.

Publicly available online educational videos regarding pediatric needle pain: a scoping review.

OBJECTIVES: The objectives of this scoping review were to: (1) identify publicly available educational videos on needle pain management; and (2) evaluate the content of these videos. METHODS: Reviewers screened publicly available educational videos on pediatric needle pain management available on YouTube and Google using a broad-based search strategy. Videos were categorized using the CRAAP Test: Current, Relevant, from a trustworthy source (Authority), Accurate and evidence-based, and for what Purpose does the source exist. RESULTS: Twenty-five relevant, educational videos were identified. The intended audience for most videos was parents (n=16, 64%), followed by clinicians (n=6, 24%) and children (n=3, 12%). Common examples of needle pain included immunizations or IV insertion, with interventions appropriate for infants through school-aged children. The most frequently described techniques were parent-guided distraction and behavioral factors such as comfort holds and parent demeanor. Most videos were Current (96%), Relevant (100%), created by a trustworthy source: Authority (76%), and all were Accurate, with Purpose relating to needle pain management. None of the videos addressed the unique needs of children with a preexisting diagnosis of needle phobia. DISCUSSION: Publicly available educational videos offer clinicians, parents, and children evidence-based techniques to manage pediatric needle pain. Further evaluation is needed to determine whether this form of education meets the needs of target audiences and whether this type of content can lead to improved management of pediatric needle pain.

A single institution's effort to translate codeine knowledge into specific clinical practice.

BACKGROUND: Codeine is an unpredictable analgesic because of its variable pharmacokinetic, pharmacodynamic, and pharmacogenetic properties. This variability may lead to ineffective analgesia in some and respiratory depression in others. Despite this, codeine is still widely used. At a pediatric tertiary medical institution, codeine was prescribed despite efforts to inform prescribers of the potentially unpredictable analgesia and serious side effects. MEASURES: A retrospective/prospective metric was introduced to determine the frequency of codeine orders as compared with similar institutions using Pediatric Health Information Systems data. INTERVENTION: Interventions included formal and informal education to prescribers, and replacing codeine with oxycodone for patients aged older than six months and an age-appropriate medication for those patients younger than six months within ordersets. Identifying and addressing the major barriers to change also was a key part of the process. OUTCOMES: Codeine use was reduced by 97% from the first quarter of 2008 through the third quarter of 2012. This was accomplished through orderset changes and education. Codeine was completely eliminated from the hospital formulary in January 2013. CONCLUSIONS/LESSONS LEARNED: This quality improvement initiative was successful in eliminating codeine from the hospital formulary. Although education decreased codeine orders, understanding and addressing the barriers to change and directly changing the ordersets were the most effective and efficient for knowledge translation.

Documented electronic medical record-based pain intensity scores at a tertiary pediatric medical center: a cohort analysis.

CONTEXT: Previous surveys have suggested that pain in hospitalized patients remains undertreated. However, little is known about those with persistently high pain scores. OBJECTIVES: To document the distribution of scores and analyze the clinical characteristics of outliers with persistently high pain scores. METHODS: With institutional review board approval, a retrospective cohort analysis of more than 1.5 million documented scores was completed in a tertiary pediatric medical center during a three-year period. Patients with persistently high pain scores were identified for subgroup analysis. RESULTS: The median score was 0 (all years), and the means were 1.46, 1.34, and 1.3 in 2010, 2011, and 2012, respectively. Approximately 68% of admissions had at least one score of 4 or greater, although this level did not persist. Only 9% had mean scores of 4 or greater, and 1% (n = 492) had mean scores of 7 or greater. Scores remained high in patients within identifiable groups, that is, those with chronic pain (n = 311), sickle cell vaso-occlusive episodes (n = 52), and pain in children with developmental and neuromuscular disorders (n = 32). Few had persistently high scores with acute pain but without known comorbidities (n = 56). CONCLUSION: Detailed review of clinical characteristics of patients with persistently high scores led to the strong impression that, in most cases, persistently high pain was not simply because of inadequate administration of opioids. Instead, the first step in improving pain management of hospitalized children may be the identification of outliers with high pain scores to direct efforts on the development of interventions for patient groups with mechanistically similar pain.

Parent described pain responses in nonverbal children with intellectual disability.

BACKGROUND: Assessing pain for nonverbal children with intellectual disability is challenging. These children are at risk for pain from complex medical conditions and the interventions to treat those conditions. Pain responses are often misunderstood, given that the children are nonverbal and limited by their physical abilities. OBJECTIVES: The general purpose was to examine the words that parents of children with intellectual disability use to describe their child's pain response in order to improve pain recognition and management. Specifically, the aims were to: (1) identify common pain responses as reported by parents; (2) examine relationships between type of pain response and independent variables; (3) compare pain responses to those identified in the literature. DESIGN: The study design includes: (1) a summative qualitative content analysis of the parent described pain responses; (2) quantitative analysis of the relationships between type of pain response and independent variables and; (3) a comparison of pain responses to those identified in the literature. SETTING: A pediatric hospital in the northeastern United States. PARTICIPANTS: Parents of 50 nonverbal children with intellectual disabilities ages 6-18 years. METHODS: A non-directed summative content analysis identified patterns within 335 parent described pain responses. Chi square analysis was used to examine relationships between type of pain response and selected demographic factors. RESULTS: Seven distinct categories of pain responses were identified. The most commonly reported pain responses were within the categories of: vocalization (39.4%), social behavior (21.8%) and facial expressions (16%). Four types of pain responses: vocalization, social behavior, muscle tone and activity level included opposite responses to pain. There were significant relationships between type of pain response and (1) pain severity; (2) causes of intellectual disabilities and; (3) sex of the child. Pain responses varied with severity. Patients with seizure disorders expressed pain more vocally. Females expressed pain with more social responses and males with more vocalizations. CONCLUSIONS: The results support evidence that parents can articulate their child's pain responses. The study provides evidence of: (1) extremes of pain responses and (2) a significant relationship between type of responses and severity of pain, cause of intellectual disability and sex of child.

Validation of the Individualized Numeric Rating Scale (INRS): a pain assessment tool for nonverbal children with intellectual disability.

Clinical observations suggest that nonverbal children with severe intellectual disability exhibit pain in a wide variety yet uniquely individual ways. Here, we investigate the feasibility and describe the initial psychometrics properties of the Individualized Numeric Rating Scale (INRS), a personalized pain assessment tool for nonverbal children with intellectual disability based on the parent's knowledge of the child. Parents of 50 nonverbal children with severe intellectual disability scheduled for surgery were able to complete the task of describing then rank ordering their child's usual and pain indicators. The parent, bedside nurse and research assistant (RA) triad then simultaneously yet independently scored the patient's post-operative pain using the INRS for a maximum of two sets of pre/post paired observations. A total of 170 triad assessments were completed before (n=85) and after (n=85) an intervention to manage the child's pain. INRS inter-rater agreement between the parents and research nurse was high (ICC 0.82-0.87) across all ratings. Parent and bedside nurse agreement (ICC 0.65-0.74) and bedside nurse and research nurse agreement (ICC 0.74-0.80) also suggest good reliability. A moderate to strong correlation (0.63-0.73) between INRS ratings and NCCPC-PV total scores provides evidence of convergent validity. These results provide preliminary data that the INRS is a valid and reliable tool for assessing pain in nonverbal children with severe intellectual disability in an acute care setting.

A randomized controlled trial to evaluate S-Caine patch for reducing pain associated with vascular access in children.

BACKGROUND: A randomized, double-blinded trial was performed to evaluate the efficacy and safety of the S-Caine Patch (ZARS, Inc., Salt Lake City, UT), a eutectic mixture of lidocaine and tetracaine, for pain relief during venipuncture in children. METHODS: With institutional review board approval, parental consent, and patient assent, 64 children who were scheduled for medically indicated vascular access at two centers were randomly assigned (2:1) to receive either an S-Caine Patch or a placebo patch for 20 min before venipuncture procedures. The primary outcome measure was the child's rating of pain during venipuncture using the Oucher pain scale. Additional measures of efficacy included the blinded investigator's and an independent observer's four-point categorical scores. Variables were compared between treatments using Mantel-Haenszel summary chi-square tests or Pearson chi-square tests. RESULTS: The S-Caine Patch produced significantly greater pain relief compared with placebo (median Oucher scores of 0 vs. 60; P < 0.001). Fifty-nine percent of the children in the S-Caine Patch group reported no pain compared with 20% of the children in the placebo patch group. The investigator estimated that 76% of the children in the S-Caine Patch group experienced no pain during venipuncture versus 20% in the placebo patch group (P = 0.001). Independent observer ratings also favored the S-Caine Patchtrade mark (P < 0.001). Mild skin erythema (< 38%) and edema (< 2%) occurred with similar frequencies between the groups. CONCLUSION: This study demonstrated that a 20-min application of the S-Caine Patch is effective in lessening pain associated with venipuncture procedures. Adverse events after S-Caine Patch application were mild and transient.